M. Alexander Otto

SAN FRANCISCO – Sublingual immunotherapy desensitized 11 children to peanut allergies in a double-blind, placebo-controlled trial.

When challenged with peanut after a year of treatment, they tolerated a median of 1,710 mg (about seven peanuts), while 7 children in the placebo arm tolerated a median of 85 mg (about one-fifth of a peanut), a 20-fold difference (P = .011).

Photo credit: © mates/Fotolia.com

The results were so impressive that the interim analysis was cut short to switch placebo children to active therapy, said senior investigator Dr. Wesley Burks, professor of pediatrics and chief of the division of pediatric allergy and immunology at Duke University Medical Center, Durham, N.C.

But however promising these results, and those of other immunotherapy trials, Dr. Burks cautioned that additional efficacy and safety verification are needed.

In some immunotherapy trials, children who seemed to tolerate gradual exposure and desensitization to their particular allergens had unexpected anaphylactic reactions, especially if they came down with a viral illness. A significant proportion of children also can’t tolerate oral immunotherapy, he said.

Those points are often missed in news reports that suggest immunotherapy cures food allergies. Until more is known, immunotherapy "is not the right thing to do right now. We don’t put people on immunotherapy unless it’s in a study," he said.

Children in the trial were aged 1- to 11-years-old and had histories of peanut reactions plus elevated peanut IgE levels.

Treated children were dose escalated over a period of 6 months to a total of 2,000 mcg of peanut protein daily, then maintenance dosed for the next 6 months. The peanut extract was placed under their tongues, held for a couple minutes, then swallowed; 2,500-mg peanut challenges came at the 1-year mark.

Although the median was 1,710 mg, "there was a pretty wide range in how much [treated children] tolerated," Dr. Burks said, with some able to handle the entire 2,500 mg, others only 200 mg.

Peanut-specific IgE increased over the first 4 months of treatment (P = .002), then steadily decreased over the remaining 8 months (P = .003). Peanut-specific IgG4 increased over the entire year of therapy (P = .014).

"Their skin-prick tests [also] went down in the first 6 months [of treatment] and stayed down" versus placebo, Dr. Burks said. Treated children had wheal sizes significantly smaller than children in the placebo group (P = .020).

The findings "suggest a significant change in the allergic response," Dr. Burks concluded.

Dosing side effects were mostly oropharyngeal and seldom required treatment.

Children in the placebo group were switched to sublingual therapy following the peanut challenges. After a year of treatment, five of the seven now tolerate 2,500 mg of peanut, with the other two tolerating between 1,500 and 2,000 mg, Dr. Burks said.

Dr. Burks disclosed that he is a consultant for Actogenix, Dannon, Intelliject, McNeil Nutritionals, Novartis, Schering-Plough (now a part of Merck), and Nutricia. He is a minority stockholder in Allertein Therapeutics and Mast Cell Pharmaceuticals.

SAN FRANCISCO – Sublingual immunotherapy desensitized 11 children to peanut allergies in a double-blind, placebo-controlled trial.

When challenged with peanut after a year of treatment, they tolerated a median of 1,710 mg (about seven peanuts), while 7 children in the placebo arm tolerated a median of 85 mg (about one-fifth of a peanut), a 20-fold difference (P = .011).

Photo credit: © mates/Fotolia.com

The results were so impressive that the interim analysis was cut short to switch placebo children to active therapy, said senior investigator Dr. Wesley Burks, professor of pediatrics and chief of the division of pediatric allergy and immunology at Duke University Medical Center, Durham, N.C.

But however promising these results, and those of other immunotherapy trials, Dr. Burks cautioned that additional efficacy and safety verification are needed.

In some immunotherapy trials, children who seemed to tolerate gradual exposure and desensitization to their particular allergens had unexpected anaphylactic reactions, especially if they came down with a viral illness. A significant proportion of children also can’t tolerate oral immunotherapy, he said.

Those points are often missed in news reports that suggest immunotherapy cures food allergies. Until more is known, immunotherapy "is not the right thing to do right now. We don’t put people on immunotherapy unless it’s in a study," he said.

Children in the trial were aged 1- to 11-years-old and had histories of peanut reactions plus elevated peanut IgE levels.

Treated children were dose escalated over a period of 6 months to a total of 2,000 mcg of peanut protein daily, then maintenance dosed for the next 6 months. The peanut extract was placed under their tongues, held for a couple minutes, then swallowed; 2,500-mg peanut challenges came at the 1-year mark.

Although the median was 1,710 mg, "there was a pretty wide range in how much [treated children] tolerated," Dr. Burks said, with some able to handle the entire 2,500 mg, others only 200 mg.

Peanut-specific IgE increased over the first 4 months of treatment (P = .002), then steadily decreased over the remaining 8 months (P = .003). Peanut-specific IgG4 increased over the entire year of therapy (P = .014).

"Their skin-prick tests [also] went down in the first 6 months [of treatment] and stayed down" versus placebo, Dr. Burks said. Treated children had wheal sizes significantly smaller than children in the placebo group (P = .020).

The findings "suggest a significant change in the allergic response," Dr. Burks concluded.

Dosing side effects were mostly oropharyngeal and seldom required treatment.

Children in the placebo group were switched to sublingual therapy following the peanut challenges. After a year of treatment, five of the seven now tolerate 2,500 mg of peanut, with the other two tolerating between 1,500 and 2,000 mg, Dr. Burks said.

Dr. Burks disclosed that he is a consultant for Actogenix, Dannon, Intelliject, McNeil Nutritionals, Novartis, Schering-Plough (now a part of Merck), and Nutricia. He is a minority stockholder in Allertein Therapeutics and Mast Cell Pharmaceuticals.

SAN FRANCISCO – Sublingual immunotherapy desensitized 11 children to peanut allergies in a double-blind, placebo-controlled trial.

When challenged with peanut after a year of treatment, they tolerated a median of 1,710 mg (about seven peanuts), while 7 children in the placebo arm tolerated a median of 85 mg (about one-fifth of a peanut), a 20-fold difference (P = .011).

Photo credit: © mates/Fotolia.com

The results were so impressive that the interim analysis was cut short to switch placebo children to active therapy, said senior investigator Dr. Wesley Burks, professor of pediatrics and chief of the division of pediatric allergy and immunology at Duke University Medical Center, Durham, N.C.

But however promising these results, and those of other immunotherapy trials, Dr. Burks cautioned that additional efficacy and safety verification are needed.

In some immunotherapy trials, children who seemed to tolerate gradual exposure and desensitization to their particular allergens had unexpected anaphylactic reactions, especially if they came down with a viral illness. A significant proportion of children also can’t tolerate oral immunotherapy, he said.

Those points are often missed in news reports that suggest immunotherapy cures food allergies. Until more is known, immunotherapy "is not the right thing to do right now. We don’t put people on immunotherapy unless it’s in a study," he said.

Children in the trial were aged 1- to 11-years-old and had histories of peanut reactions plus elevated peanut IgE levels.

Treated children were dose escalated over a period of 6 months to a total of 2,000 mcg of peanut protein daily, then maintenance dosed for the next 6 months. The peanut extract was placed under their tongues, held for a couple minutes, then swallowed; 2,500-mg peanut challenges came at the 1-year mark.

Although the median was 1,710 mg, "there was a pretty wide range in how much [treated children] tolerated," Dr. Burks said, with some able to handle the entire 2,500 mg, others only 200 mg.

Peanut-specific IgE increased over the first 4 months of treatment (P = .002), then steadily decreased over the remaining 8 months (P = .003). Peanut-specific IgG4 increased over the entire year of therapy (P = .014).

"Their skin-prick tests [also] went down in the first 6 months [of treatment] and stayed down" versus placebo, Dr. Burks said. Treated children had wheal sizes significantly smaller than children in the placebo group (P = .020).

The findings "suggest a significant change in the allergic response," Dr. Burks concluded.

Dosing side effects were mostly oropharyngeal and seldom required treatment.

Children in the placebo group were switched to sublingual therapy following the peanut challenges. After a year of treatment, five of the seven now tolerate 2,500 mg of peanut, with the other two tolerating between 1,500 and 2,000 mg, Dr. Burks said.

Dr. Burks disclosed that he is a consultant for Actogenix, Dannon, Intelliject, McNeil Nutritionals, Novartis, Schering-Plough (now a part of Merck), and Nutricia. He is a minority stockholder in Allertein Therapeutics and Mast Cell Pharmaceuticals.

SAN FRANCISCO – In a University of Toronto case series, 150-mg injections of omalizumab (Xolair) put seven of nine patients with severe, refractory chronic idiopathic urticaria into remission, sometimes after the first injection.

There have been other reports of the anti-IgE monoclonal antibody successfully treating refractory chronic idiopathic urticaria (CIU), but usually at higher doses.

"Because of the cost, we wanted to see if it would work at 150 mg," the standard dose for asthma, said lead investigator Dr. Gordon Sussman, division director of clinical allergy and immunology at the university.

Cost was an issue because the patients paid for the biologic themselves. Although omalizumab carries an asthma indication, it is not yet indicated for chronic urticaria, and so was not covered by the patients’ insurance. A single 150-mg injection costs from $500-$1,000, Dr. Sussman said at the annual meeting of the American Academy of Allergy, Asthma, and Immunology.

"The patients paid for it, and would pay for it again because it’s effective," he said.

"The standard dose seemed to work after one treatment. In some people [hives came back] in sometimes 2 months, sometimes 4 months. But when [they] came back and we treated people again, they seemed to be able to respond to the second treatment," Dr. Sussman said.

The five women and four men in the series were aged 27-66 years (mean 47.7) and had suffered from severe, refractory CIU from 1-13 years (mean 5.5). Initial IgE levels ranged up to 750 mcg/L. Initial urticaria activity scores ranged from about 33 to 40.

They were all taking nonsedating antihistamines, 20- to 50-mg prednisone daily, and other drugs to control their hives, without success.

The first patient was dosed at 225 mg based on an IgE of 384 mcg/L but because of the cost issue, subsequent patients were treated with 150-mg doses. They each received from one to five doses spaced from 2-10 weeks apart, depending on symptoms.

The 225-mg patient and four 150-mg patients went into spontaneous remissions within a week of their first injections. Another two patients went into remission after two 150-mg injections and another patient after three.

Dr. Sussman and his colleagues took those patients off their prednisone, but kept them on their antihistamines, the standard treatment for urticaria.

Three patients have remained symptom free for up to 8 months. Other patients have gotten follow-up omalizumab shots as needed.

A ninth patient went into remission after three doses, but symptoms returned after several months. A second course of three injections had little effect, and the woman is currently on 10-mg dose of prednisone daily.

"She responded at first very well, and then she rebounded. At this point she’s refractory. So it doesn’t work for everyone," Dr. Sussman said.

Initial IgE level "is not really a predictor" of response, he noted. "We don’t think [the effect] is related to IgE. My hypothesis is that maybe it’s related to down-regulation of IgE receptors in some way that we don’t really understand."

Even so, "Xolair seems to work quickly after the first treatment. We think it’s a real effect," Dr. Sussman said.

Dr. Sussman said he had no relevant financial disclosures. The case series received no outside funding.

SAN FRANCISCO – In a University of Toronto case series, 150-mg injections of omalizumab (Xolair) put seven of nine patients with severe, refractory chronic idiopathic urticaria into remission, sometimes after the first injection.

There have been other reports of the anti-IgE monoclonal antibody successfully treating refractory chronic idiopathic urticaria (CIU), but usually at higher doses.

"Because of the cost, we wanted to see if it would work at 150 mg," the standard dose for asthma, said lead investigator Dr. Gordon Sussman, division director of clinical allergy and immunology at the university.

Cost was an issue because the patients paid for the biologic themselves. Although omalizumab carries an asthma indication, it is not yet indicated for chronic urticaria, and so was not covered by the patients’ insurance. A single 150-mg injection costs from $500-$1,000, Dr. Sussman said at the annual meeting of the American Academy of Allergy, Asthma, and Immunology.

"The patients paid for it, and would pay for it again because it’s effective," he said.

"The standard dose seemed to work after one treatment. In some people [hives came back] in sometimes 2 months, sometimes 4 months. But when [they] came back and we treated people again, they seemed to be able to respond to the second treatment," Dr. Sussman said.

The five women and four men in the series were aged 27-66 years (mean 47.7) and had suffered from severe, refractory CIU from 1-13 years (mean 5.5). Initial IgE levels ranged up to 750 mcg/L. Initial urticaria activity scores ranged from about 33 to 40.

They were all taking nonsedating antihistamines, 20- to 50-mg prednisone daily, and other drugs to control their hives, without success.

The first patient was dosed at 225 mg based on an IgE of 384 mcg/L but because of the cost issue, subsequent patients were treated with 150-mg doses. They each received from one to five doses spaced from 2-10 weeks apart, depending on symptoms.

The 225-mg patient and four 150-mg patients went into spontaneous remissions within a week of their first injections. Another two patients went into remission after two 150-mg injections and another patient after three.

Dr. Sussman and his colleagues took those patients off their prednisone, but kept them on their antihistamines, the standard treatment for urticaria.

Three patients have remained symptom free for up to 8 months. Other patients have gotten follow-up omalizumab shots as needed.

A ninth patient went into remission after three doses, but symptoms returned after several months. A second course of three injections had little effect, and the woman is currently on 10-mg dose of prednisone daily.

"She responded at first very well, and then she rebounded. At this point she’s refractory. So it doesn’t work for everyone," Dr. Sussman said.

Initial IgE level "is not really a predictor" of response, he noted. "We don’t think [the effect] is related to IgE. My hypothesis is that maybe it’s related to down-regulation of IgE receptors in some way that we don’t really understand."

Even so, "Xolair seems to work quickly after the first treatment. We think it’s a real effect," Dr. Sussman said.

Dr. Sussman said he had no relevant financial disclosures. The case series received no outside funding.

SAN FRANCISCO – In a University of Toronto case series, 150-mg injections of omalizumab (Xolair) put seven of nine patients with severe, refractory chronic idiopathic urticaria into remission, sometimes after the first injection.

There have been other reports of the anti-IgE monoclonal antibody successfully treating refractory chronic idiopathic urticaria (CIU), but usually at higher doses.

"Because of the cost, we wanted to see if it would work at 150 mg," the standard dose for asthma, said lead investigator Dr. Gordon Sussman, division director of clinical allergy and immunology at the university.

Cost was an issue because the patients paid for the biologic themselves. Although omalizumab carries an asthma indication, it is not yet indicated for chronic urticaria, and so was not covered by the patients’ insurance. A single 150-mg injection costs from $500-$1,000, Dr. Sussman said at the annual meeting of the American Academy of Allergy, Asthma, and Immunology.

"The patients paid for it, and would pay for it again because it’s effective," he said.

"The standard dose seemed to work after one treatment. In some people [hives came back] in sometimes 2 months, sometimes 4 months. But when [they] came back and we treated people again, they seemed to be able to respond to the second treatment," Dr. Sussman said.

The five women and four men in the series were aged 27-66 years (mean 47.7) and had suffered from severe, refractory CIU from 1-13 years (mean 5.5). Initial IgE levels ranged up to 750 mcg/L. Initial urticaria activity scores ranged from about 33 to 40.

They were all taking nonsedating antihistamines, 20- to 50-mg prednisone daily, and other drugs to control their hives, without success.

The first patient was dosed at 225 mg based on an IgE of 384 mcg/L but because of the cost issue, subsequent patients were treated with 150-mg doses. They each received from one to five doses spaced from 2-10 weeks apart, depending on symptoms.

The 225-mg patient and four 150-mg patients went into spontaneous remissions within a week of their first injections. Another two patients went into remission after two 150-mg injections and another patient after three.

Dr. Sussman and his colleagues took those patients off their prednisone, but kept them on their antihistamines, the standard treatment for urticaria.

Three patients have remained symptom free for up to 8 months. Other patients have gotten follow-up omalizumab shots as needed.

A ninth patient went into remission after three doses, but symptoms returned after several months. A second course of three injections had little effect, and the woman is currently on 10-mg dose of prednisone daily.

"She responded at first very well, and then she rebounded. At this point she’s refractory. So it doesn’t work for everyone," Dr. Sussman said.

Initial IgE level "is not really a predictor" of response, he noted. "We don’t think [the effect] is related to IgE. My hypothesis is that maybe it’s related to down-regulation of IgE receptors in some way that we don’t really understand."

Even so, "Xolair seems to work quickly after the first treatment. We think it’s a real effect," Dr. Sussman said.

Dr. Sussman said he had no relevant financial disclosures. The case series received no outside funding.

SAN FRANCISCO – In a University of Toronto case series, 150-mg injections of omalizumab (Xolair) put seven of nine patients with severe, refractory chronic idiopathic urticaria into remission, sometimes after the first injection.

There have been other reports of the anti-IgE monoclonal antibody successfully treating refractory chronic idiopathic urticaria (CIU), but usually at higher doses.

"Because of the cost, we wanted to see if it would work at 150 mg," the standard dose for asthma, said lead investigator Dr. Gordon Sussman, division director of clinical allergy and immunology at the university.

Cost was an issue because the patients paid for the biologic themselves. Although omalizumab carries an asthma indication, it is not yet indicated for chronic urticaria, and so was not covered by the patients’ insurance. A single 150-mg injection costs from $500-$1,000, Dr. Sussman said at the annual meeting of the American Academy of Allergy, Asthma, and Immunology.

"The patients paid for it, and would pay for it again because it’s effective," he said.

"The standard dose seemed to work after one treatment. In some people [hives came back] in sometimes 2 months, sometimes 4 months. But when [they] came back and we treated people again, they seemed to be able to respond to the second treatment," Dr. Sussman said.

The five women and four men in the series were aged 27-66 years (mean 47.7) and had suffered from severe, refractory CIU from 1-13 years (mean 5.5). Initial IgE levels ranged up to 750 mcg/L. Initial urticaria activity scores ranged from about 33 to 40.

They were all taking nonsedating antihistamines, 20- to 50-mg prednisone daily, and other drugs to control their hives, without success.

The first patient was dosed at 225 mg based on an IgE of 384 mcg/L but because of the cost issue, subsequent patients were treated with 150-mg doses. They each received from one to five doses spaced from 2-10 weeks apart, depending on symptoms.

The 225-mg patient and four 150-mg patients went into spontaneous remissions within a week of their first injections. Another two patients went into remission after two 150-mg injections and another patient after three.

Dr. Sussman and his colleagues took those patients off their prednisone, but kept them on their antihistamines, the standard treatment for urticaria.

Three patients have remained symptom free for up to 8 months. Other patients have gotten follow-up omalizumab shots as needed.

A ninth patient went into remission after three doses, but symptoms returned after several months. A second course of three injections had little effect, and the woman is currently on 10-mg dose of prednisone daily.

"She responded at first very well, and then she rebounded. At this point she’s refractory. So it doesn’t work for everyone," Dr. Sussman said.

Initial IgE level "is not really a predictor" of response, he noted. "We don’t think [the effect] is related to IgE. My hypothesis is that maybe it’s related to down-regulation of IgE receptors in some way that we don’t really understand."

Even so, "Xolair seems to work quickly after the first treatment. We think it’s a real effect," Dr. Sussman said.

Dr. Sussman said he had no relevant financial disclosures. The case series received no outside funding.

SAN FRANCISCO – In a University of Toronto case series, 150-mg injections of omalizumab (Xolair) put seven of nine patients with severe, refractory chronic idiopathic urticaria into remission, sometimes after the first injection.

There have been other reports of the anti-IgE monoclonal antibody successfully treating refractory chronic idiopathic urticaria (CIU), but usually at higher doses.

"Because of the cost, we wanted to see if it would work at 150 mg," the standard dose for asthma, said lead investigator Dr. Gordon Sussman, division director of clinical allergy and immunology at the university.

Cost was an issue because the patients paid for the biologic themselves. Although omalizumab carries an asthma indication, it is not yet indicated for chronic urticaria, and so was not covered by the patients’ insurance. A single 150-mg injection costs from $500-$1,000, Dr. Sussman said at the annual meeting of the American Academy of Allergy, Asthma, and Immunology.

"The patients paid for it, and would pay for it again because it’s effective," he said.

"The standard dose seemed to work after one treatment. In some people [hives came back] in sometimes 2 months, sometimes 4 months. But when [they] came back and we treated people again, they seemed to be able to respond to the second treatment," Dr. Sussman said.

The five women and four men in the series were aged 27-66 years (mean 47.7) and had suffered from severe, refractory CIU from 1-13 years (mean 5.5). Initial IgE levels ranged up to 750 mcg/L. Initial urticaria activity scores ranged from about 33 to 40.

They were all taking nonsedating antihistamines, 20- to 50-mg prednisone daily, and other drugs to control their hives, without success.

The first patient was dosed at 225 mg based on an IgE of 384 mcg/L but because of the cost issue, subsequent patients were treated with 150-mg doses. They each received from one to five doses spaced from 2-10 weeks apart, depending on symptoms.

The 225-mg patient and four 150-mg patients went into spontaneous remissions within a week of their first injections. Another two patients went into remission after two 150-mg injections and another patient after three.

Dr. Sussman and his colleagues took those patients off their prednisone, but kept them on their antihistamines, the standard treatment for urticaria.

Three patients have remained symptom free for up to 8 months. Other patients have gotten follow-up omalizumab shots as needed.

A ninth patient went into remission after three doses, but symptoms returned after several months. A second course of three injections had little effect, and the woman is currently on 10-mg dose of prednisone daily.

"She responded at first very well, and then she rebounded. At this point she’s refractory. So it doesn’t work for everyone," Dr. Sussman said.

Initial IgE level "is not really a predictor" of response, he noted. "We don’t think [the effect] is related to IgE. My hypothesis is that maybe it’s related to down-regulation of IgE receptors in some way that we don’t really understand."

Even so, "Xolair seems to work quickly after the first treatment. We think it’s a real effect," Dr. Sussman said.

Dr. Sussman said he had no relevant financial disclosures. The case series received no outside funding.

SAN FRANCISCO – In a University of Toronto case series, 150-mg injections of omalizumab (Xolair) put seven of nine patients with severe, refractory chronic idiopathic urticaria into remission, sometimes after the first injection.

There have been other reports of the anti-IgE monoclonal antibody successfully treating refractory chronic idiopathic urticaria (CIU), but usually at higher doses.

"Because of the cost, we wanted to see if it would work at 150 mg," the standard dose for asthma, said lead investigator Dr. Gordon Sussman, division director of clinical allergy and immunology at the university.

Cost was an issue because the patients paid for the biologic themselves. Although omalizumab carries an asthma indication, it is not yet indicated for chronic urticaria, and so was not covered by the patients’ insurance. A single 150-mg injection costs from $500-$1,000, Dr. Sussman said at the annual meeting of the American Academy of Allergy, Asthma, and Immunology.

"The patients paid for it, and would pay for it again because it’s effective," he said.

"The standard dose seemed to work after one treatment. In some people [hives came back] in sometimes 2 months, sometimes 4 months. But when [they] came back and we treated people again, they seemed to be able to respond to the second treatment," Dr. Sussman said.

The five women and four men in the series were aged 27-66 years (mean 47.7) and had suffered from severe, refractory CIU from 1-13 years (mean 5.5). Initial IgE levels ranged up to 750 mcg/L. Initial urticaria activity scores ranged from about 33 to 40.

They were all taking nonsedating antihistamines, 20- to 50-mg prednisone daily, and other drugs to control their hives, without success.

The first patient was dosed at 225 mg based on an IgE of 384 mcg/L but because of the cost issue, subsequent patients were treated with 150-mg doses. They each received from one to five doses spaced from 2-10 weeks apart, depending on symptoms.

The 225-mg patient and four 150-mg patients went into spontaneous remissions within a week of their first injections. Another two patients went into remission after two 150-mg injections and another patient after three.

Dr. Sussman and his colleagues took those patients off their prednisone, but kept them on their antihistamines, the standard treatment for urticaria.

Three patients have remained symptom free for up to 8 months. Other patients have gotten follow-up omalizumab shots as needed.

A ninth patient went into remission after three doses, but symptoms returned after several months. A second course of three injections had little effect, and the woman is currently on 10-mg dose of prednisone daily.

"She responded at first very well, and then she rebounded. At this point she’s refractory. So it doesn’t work for everyone," Dr. Sussman said.

Initial IgE level "is not really a predictor" of response, he noted. "We don’t think [the effect] is related to IgE. My hypothesis is that maybe it’s related to down-regulation of IgE receptors in some way that we don’t really understand."

Even so, "Xolair seems to work quickly after the first treatment. We think it’s a real effect," Dr. Sussman said.

Dr. Sussman said he had no relevant financial disclosures. The case series received no outside funding.

VANCOUVER, B.C. – Precedex (dexmedetomidine), a drug used for years by intensivists and anesthesiologists for sedation, is increasingly being recognized as a valuable palliative care tool, according to Dr. Ellen M. Flanagan.

The alpha-2 agonist is an opioid-sparing analgesic that does not depress respiratory function; an anxiolytic with benzodiazepine-like activity but less risk of delirium and disinhibition; and a sedative from which patients can be aroused, among other properties, said Dr. Flanagan, an anesthesiologist at Duke University, Durham, N.C., with a special interest in palliative and end-of-life care.

Precedex "is incredible. It has really got some pretty profound implications for those patients who are having horrible deaths [with] intractable pain, agitation, and delirium." When standard drugs are "not sufficient to control symptoms, Precedex could do the trick," she said at the annual meeting of the American Academy of Hospice and Palliative Care Medicine.

Intensive-care doctors and anesthesiologists use the drug routinely. More than 4.5 million vials have been administered since the Food and Drug Administration approved it in 1999 to sedate intubated and mechanically ventilated ICU patients. The drug received a second indication in 2008 for sedation of nonintubated patients before or during surgical and other procedures.

But "it’s a new drug to most palliative care physicians," Dr. Flanagan said.

Part of the reason is that Precedex has not been studied in palliative care patients. To date, case reports offer the strongest evidence of palliative efficacy, she said.

Dr. Flanagan and her colleagues hope to change the situation. Their investigational new drug application was approved by the FDA for a study in nine advanced cancer patients in the final week of life.

The team will assess the drug’s impact as an add-on to standard therapy for pain, agitation, delirium, communication capacity, dyspnea, vomiting, and oral secretions. The team is currently negotiating funding with Hospira, the drug’s maker, and other possible sources.

For now, the best dose, duration, and symptom targets for palliative care remain uncertain, she said.

Still, nurse practitioner Jennifer Gentry, palliative care services clinical coordinator at Duke and copresenter with Dr. Flanagan, said she has seen Precedex ease end-of-life suffering when other drugs failed to do so adequately, and enable reductions in opioid use so patients could be extubated and allowed to die in hospice or other comfortable settings, instead of the ICU.

Meanwhile, studies in other populations have shown good effect, Dr. Flanagan said.

In a study of postoperative pain control in 100 women following hysterectomy, women given Precedex required 29% less morphine and reported less pain and nausea on the first postoperative day. Sedation was similar between the morphine alone and morphine-plus-Precedex groups (Br. J. Anaesth. 2009;102:117-22).

In another trial of mechanically ventilated ICU patients, 54% of 244 patients given Precedex 0.2-1.4 mcg/kg per hour experienced delirium, but 76.6% of 122 given midazolam 0.02-0.1 mg/kg per hour became delirious. Precedex patients were able to be extubated a median of 1.9 days sooner, as well (JAMA 2009;301:489-99).

In general, the drug provides arousable sedation, which "I think is one of the most incredible things about it. Instead of just titrating morphine until the patient is unconscious, the patient can be sedated so they look like they’re sleeping, and you shake their shoulder and all of a sudden they are awake. When the family comes in and wants to talk, you may be able to arouse that patient" for meaningful communication, Dr. Flanagan said.

Precedex is expensive, however, at about $58/100 mcg, or about $600 per day. It’s coming off patent in 2013, so less-expensive generic formulations may soon be available, she said.

The drug’s side effects include dry mouth, hypotension, and bradycardia. For the study, "we did a lot of work with the FDA to try to set up parameters trying to figure out what [bradycardia and hypotension] might be due to drug and what might be due to the natural trajectory of death," Dr. Flanagan said.

Dr. Flanagan said she has no financial interests in Precedex.

VANCOUVER, B.C. – Precedex (dexmedetomidine), a drug used for years by intensivists and anesthesiologists for sedation, is increasingly being recognized as a valuable palliative care tool, according to Dr. Ellen M. Flanagan.

The alpha-2 agonist is an opioid-sparing analgesic that does not depress respiratory function; an anxiolytic with benzodiazepine-like activity but less risk of delirium and disinhibition; and a sedative from which patients can be aroused, among other properties, said Dr. Flanagan, an anesthesiologist at Duke University, Durham, N.C., with a special interest in palliative and end-of-life care.

Precedex "is incredible. It has really got some pretty profound implications for those patients who are having horrible deaths [with] intractable pain, agitation, and delirium." When standard drugs are "not sufficient to control symptoms, Precedex could do the trick," she said at the annual meeting of the American Academy of Hospice and Palliative Care Medicine.

Intensive-care doctors and anesthesiologists use the drug routinely. More than 4.5 million vials have been administered since the Food and Drug Administration approved it in 1999 to sedate intubated and mechanically ventilated ICU patients. The drug received a second indication in 2008 for sedation of nonintubated patients before or during surgical and other procedures.

But "it’s a new drug to most palliative care physicians," Dr. Flanagan said.

Part of the reason is that Precedex has not been studied in palliative care patients. To date, case reports offer the strongest evidence of palliative efficacy, she said.

Dr. Flanagan and her colleagues hope to change the situation. Their investigational new drug application was approved by the FDA for a study in nine advanced cancer patients in the final week of life.

The team will assess the drug’s impact as an add-on to standard therapy for pain, agitation, delirium, communication capacity, dyspnea, vomiting, and oral secretions. The team is currently negotiating funding with Hospira, the drug’s maker, and other possible sources.

For now, the best dose, duration, and symptom targets for palliative care remain uncertain, she said.

Still, nurse practitioner Jennifer Gentry, palliative care services clinical coordinator at Duke and copresenter with Dr. Flanagan, said she has seen Precedex ease end-of-life suffering when other drugs failed to do so adequately, and enable reductions in opioid use so patients could be extubated and allowed to die in hospice or other comfortable settings, instead of the ICU.

Meanwhile, studies in other populations have shown good effect, Dr. Flanagan said.

In a study of postoperative pain control in 100 women following hysterectomy, women given Precedex required 29% less morphine and reported less pain and nausea on the first postoperative day. Sedation was similar between the morphine alone and morphine-plus-Precedex groups (Br. J. Anaesth. 2009;102:117-22).

In another trial of mechanically ventilated ICU patients, 54% of 244 patients given Precedex 0.2-1.4 mcg/kg per hour experienced delirium, but 76.6% of 122 given midazolam 0.02-0.1 mg/kg per hour became delirious. Precedex patients were able to be extubated a median of 1.9 days sooner, as well (JAMA 2009;301:489-99).

In general, the drug provides arousable sedation, which "I think is one of the most incredible things about it. Instead of just titrating morphine until the patient is unconscious, the patient can be sedated so they look like they’re sleeping, and you shake their shoulder and all of a sudden they are awake. When the family comes in and wants to talk, you may be able to arouse that patient" for meaningful communication, Dr. Flanagan said.

Precedex is expensive, however, at about $58/100 mcg, or about $600 per day. It’s coming off patent in 2013, so less-expensive generic formulations may soon be available, she said.

The drug’s side effects include dry mouth, hypotension, and bradycardia. For the study, "we did a lot of work with the FDA to try to set up parameters trying to figure out what [bradycardia and hypotension] might be due to drug and what might be due to the natural trajectory of death," Dr. Flanagan said.

Dr. Flanagan said she has no financial interests in Precedex.

VANCOUVER, B.C. – Precedex (dexmedetomidine), a drug used for years by intensivists and anesthesiologists for sedation, is increasingly being recognized as a valuable palliative care tool, according to Dr. Ellen M. Flanagan.

The alpha-2 agonist is an opioid-sparing analgesic that does not depress respiratory function; an anxiolytic with benzodiazepine-like activity but less risk of delirium and disinhibition; and a sedative from which patients can be aroused, among other properties, said Dr. Flanagan, an anesthesiologist at Duke University, Durham, N.C., with a special interest in palliative and end-of-life care.

Precedex "is incredible. It has really got some pretty profound implications for those patients who are having horrible deaths [with] intractable pain, agitation, and delirium." When standard drugs are "not sufficient to control symptoms, Precedex could do the trick," she said at the annual meeting of the American Academy of Hospice and Palliative Care Medicine.

Intensive-care doctors and anesthesiologists use the drug routinely. More than 4.5 million vials have been administered since the Food and Drug Administration approved it in 1999 to sedate intubated and mechanically ventilated ICU patients. The drug received a second indication in 2008 for sedation of nonintubated patients before or during surgical and other procedures.

But "it’s a new drug to most palliative care physicians," Dr. Flanagan said.

Part of the reason is that Precedex has not been studied in palliative care patients. To date, case reports offer the strongest evidence of palliative efficacy, she said.

Dr. Flanagan and her colleagues hope to change the situation. Their investigational new drug application was approved by the FDA for a study in nine advanced cancer patients in the final week of life.

The team will assess the drug’s impact as an add-on to standard therapy for pain, agitation, delirium, communication capacity, dyspnea, vomiting, and oral secretions. The team is currently negotiating funding with Hospira, the drug’s maker, and other possible sources.

For now, the best dose, duration, and symptom targets for palliative care remain uncertain, she said.

Still, nurse practitioner Jennifer Gentry, palliative care services clinical coordinator at Duke and copresenter with Dr. Flanagan, said she has seen Precedex ease end-of-life suffering when other drugs failed to do so adequately, and enable reductions in opioid use so patients could be extubated and allowed to die in hospice or other comfortable settings, instead of the ICU.

Meanwhile, studies in other populations have shown good effect, Dr. Flanagan said.

In a study of postoperative pain control in 100 women following hysterectomy, women given Precedex required 29% less morphine and reported less pain and nausea on the first postoperative day. Sedation was similar between the morphine alone and morphine-plus-Precedex groups (Br. J. Anaesth. 2009;102:117-22).

In another trial of mechanically ventilated ICU patients, 54% of 244 patients given Precedex 0.2-1.4 mcg/kg per hour experienced delirium, but 76.6% of 122 given midazolam 0.02-0.1 mg/kg per hour became delirious. Precedex patients were able to be extubated a median of 1.9 days sooner, as well (JAMA 2009;301:489-99).

In general, the drug provides arousable sedation, which "I think is one of the most incredible things about it. Instead of just titrating morphine until the patient is unconscious, the patient can be sedated so they look like they’re sleeping, and you shake their shoulder and all of a sudden they are awake. When the family comes in and wants to talk, you may be able to arouse that patient" for meaningful communication, Dr. Flanagan said.

Precedex is expensive, however, at about $58/100 mcg, or about $600 per day. It’s coming off patent in 2013, so less-expensive generic formulations may soon be available, she said.

The drug’s side effects include dry mouth, hypotension, and bradycardia. For the study, "we did a lot of work with the FDA to try to set up parameters trying to figure out what [bradycardia and hypotension] might be due to drug and what might be due to the natural trajectory of death," Dr. Flanagan said.

Dr. Flanagan said she has no financial interests in Precedex.

VANCOUVER, B.C. – Gynecologic cancer symptoms may be more severe in younger women; in women with histories of anxiety, depression, and chronic pain; and in women on active treatment, according to survey results from the University of California, San Francisco.

The findings suggest that outpatient palliative care might best be targeted to women in those categories, said lead investigator Dr. Carolyn Casey, an ob.gyn. with the UCSF Helen Diller Family Comprehensive Cancer Center, San Francisco.

She cautioned against overinterpretation, however. The comparisons are unadjusted and simply correlations at this point. "They don’t speak to the ‘whys’ at all," she said.

The findings are important because outpatient palliative care is a newer field and not routinely offered in all cancer centers. Data are limited on who is most likely to benefit.

The handful of previous symptom studies in outpatient gynecologic cancer patients had fewer than 75 patients, and most women had ovarian cancer and were on chemotherapy.

Dr. Casey and her colleagues wanted a broader sample, so they gave Edmonton Symptom Assessment Scale (ESAS) surveys to 305 women in the gynecologic oncology waiting room over a 19-month period, asking them about symptoms during the previous week. The response rate to the survey is unknown at this point.

About 53% of respondents were between 50 and 70 years old, with 18% older and 29% younger; 46% had ovarian cancer, 37% endometrial cancer, and 17% cervical cancer.

The women were split fairly evenly between early- and late-stage disease and between being on and off treatment. Over a third had no evidence of cancer at the time of the survey. About 17% had histories of anxiety or depression, and 11% had chronic pain histories.

The survey asked women to rate pain, fatigue, anxiety, depression, and well-being on a 10-point scale, with 10 being worst. Severity scores of 4 or higher were considered clinically significant.

Thirty-two percent of the women reported clinically significant pain; 32%, depression; 45%, anxiety; and 47%, fatigue.

"We thought that was pretty high, especially in a population where over a third had no evidence of disease. It highlights a high symptom burden in this population that deserves attention," Dr. Casey said.

The findings also illustrate "the potential benefit of incorporating standardized symptom burden evaluations into clinic visits, and targeting patients found to have higher symptom burdens for referrals to, or at least discussion of, the option of concurrent outpatient palliative care," she said.

Simply asking women whether they’d like outpatient help with their symptoms, a question included in the survey, proved to be an excellent screening method for appropriate referral.

Positive responses "really did highlight a group that had a much higher symptom burden across the board. It turns out that just asking a patient if they are interested in that referral does pretty much as good a job as any other categorization," Dr. Casey said.

She and her colleagues compared women aged less than 50 years to women over 70 and found a trend toward greater symptom burden in younger patients, although it reached statistical significance only for pain; 44% of women under 50 reported pain at or above level 4 severity, while that level of pain was reported by only 17% of women over 70 (P = .001).

No difference in symptom burden was found by cancer stage and no statistically significant difference by type of cancer, although there was a trend toward less pain and fatigue in endometrial cancer and less anxiety in cervical cancer.

"Not surprisingly, patients with no evidence of disease at the time of their visit had a lower symptom burden across the board," Dr. Casey said. Similarly, those under treatment had a greater burden of anxiety and fatigue and worse well-being.

A chronic pain history correlated with increased pain, fatigue, and depression. Patients with a history of depression or anxiety had greater anxiety and fatigue and a worse sense of well-being.

For instance, 66% of women with anxiety or depression histories reported fatigue; the prevalence was 45% among women without those histories (P = .016). About 60% with chronic pain histories reported depression; depression was reported by 30% of those without that history (P = .002).

Without the comparisons being adjusted, it’s possible younger patients were simply more likely to be on treatment at the time of the survey, or treated more aggressively. Perhaps older women were less likely to report symptoms.

"We just don’t know," Dr. Casey said.

Dr. Casey said she had no relevant financial disclosures.

VANCOUVER, B.C. – Gynecologic cancer symptoms may be more severe in younger women; in women with histories of anxiety, depression, and chronic pain; and in women on active treatment, according to survey results from the University of California, San Francisco.

The findings suggest that outpatient palliative care might best be targeted to women in those categories, said lead investigator Dr. Carolyn Casey, an ob.gyn. with the UCSF Helen Diller Family Comprehensive Cancer Center, San Francisco.

She cautioned against overinterpretation, however. The comparisons are unadjusted and simply correlations at this point. "They don’t speak to the ‘whys’ at all," she said.

The findings are important because outpatient palliative care is a newer field and not routinely offered in all cancer centers. Data are limited on who is most likely to benefit.

The handful of previous symptom studies in outpatient gynecologic cancer patients had fewer than 75 patients, and most women had ovarian cancer and were on chemotherapy.

Dr. Casey and her colleagues wanted a broader sample, so they gave Edmonton Symptom Assessment Scale (ESAS) surveys to 305 women in the gynecologic oncology waiting room over a 19-month period, asking them about symptoms during the previous week. The response rate to the survey is unknown at this point.

About 53% of respondents were between 50 and 70 years old, with 18% older and 29% younger; 46% had ovarian cancer, 37% endometrial cancer, and 17% cervical cancer.

The women were split fairly evenly between early- and late-stage disease and between being on and off treatment. Over a third had no evidence of cancer at the time of the survey. About 17% had histories of anxiety or depression, and 11% had chronic pain histories.

The survey asked women to rate pain, fatigue, anxiety, depression, and well-being on a 10-point scale, with 10 being worst. Severity scores of 4 or higher were considered clinically significant.

Thirty-two percent of the women reported clinically significant pain; 32%, depression; 45%, anxiety; and 47%, fatigue.

"We thought that was pretty high, especially in a population where over a third had no evidence of disease. It highlights a high symptom burden in this population that deserves attention," Dr. Casey said.

The findings also illustrate "the potential benefit of incorporating standardized symptom burden evaluations into clinic visits, and targeting patients found to have higher symptom burdens for referrals to, or at least discussion of, the option of concurrent outpatient palliative care," she said.

Simply asking women whether they’d like outpatient help with their symptoms, a question included in the survey, proved to be an excellent screening method for appropriate referral.

Positive responses "really did highlight a group that had a much higher symptom burden across the board. It turns out that just asking a patient if they are interested in that referral does pretty much as good a job as any other categorization," Dr. Casey said.

She and her colleagues compared women aged less than 50 years to women over 70 and found a trend toward greater symptom burden in younger patients, although it reached statistical significance only for pain; 44% of women under 50 reported pain at or above level 4 severity, while that level of pain was reported by only 17% of women over 70 (P = .001).

No difference in symptom burden was found by cancer stage and no statistically significant difference by type of cancer, although there was a trend toward less pain and fatigue in endometrial cancer and less anxiety in cervical cancer.

"Not surprisingly, patients with no evidence of disease at the time of their visit had a lower symptom burden across the board," Dr. Casey said. Similarly, those under treatment had a greater burden of anxiety and fatigue and worse well-being.

A chronic pain history correlated with increased pain, fatigue, and depression. Patients with a history of depression or anxiety had greater anxiety and fatigue and a worse sense of well-being.

For instance, 66% of women with anxiety or depression histories reported fatigue; the prevalence was 45% among women without those histories (P = .016). About 60% with chronic pain histories reported depression; depression was reported by 30% of those without that history (P = .002).

Without the comparisons being adjusted, it’s possible younger patients were simply more likely to be on treatment at the time of the survey, or treated more aggressively. Perhaps older women were less likely to report symptoms.

"We just don’t know," Dr. Casey said.

Dr. Casey said she had no relevant financial disclosures.

VANCOUVER, B.C. – Gynecologic cancer symptoms may be more severe in younger women; in women with histories of anxiety, depression, and chronic pain; and in women on active treatment, according to survey results from the University of California, San Francisco.

The findings suggest that outpatient palliative care might best be targeted to women in those categories, said lead investigator Dr. Carolyn Casey, an ob.gyn. with the UCSF Helen Diller Family Comprehensive Cancer Center, San Francisco.

She cautioned against overinterpretation, however. The comparisons are unadjusted and simply correlations at this point. "They don’t speak to the ‘whys’ at all," she said.

The findings are important because outpatient palliative care is a newer field and not routinely offered in all cancer centers. Data are limited on who is most likely to benefit.

The handful of previous symptom studies in outpatient gynecologic cancer patients had fewer than 75 patients, and most women had ovarian cancer and were on chemotherapy.

Dr. Casey and her colleagues wanted a broader sample, so they gave Edmonton Symptom Assessment Scale (ESAS) surveys to 305 women in the gynecologic oncology waiting room over a 19-month period, asking them about symptoms during the previous week. The response rate to the survey is unknown at this point.

About 53% of respondents were between 50 and 70 years old, with 18% older and 29% younger; 46% had ovarian cancer, 37% endometrial cancer, and 17% cervical cancer.

The women were split fairly evenly between early- and late-stage disease and between being on and off treatment. Over a third had no evidence of cancer at the time of the survey. About 17% had histories of anxiety or depression, and 11% had chronic pain histories.

The survey asked women to rate pain, fatigue, anxiety, depression, and well-being on a 10-point scale, with 10 being worst. Severity scores of 4 or higher were considered clinically significant.

Thirty-two percent of the women reported clinically significant pain; 32%, depression; 45%, anxiety; and 47%, fatigue.

"We thought that was pretty high, especially in a population where over a third had no evidence of disease. It highlights a high symptom burden in this population that deserves attention," Dr. Casey said.

The findings also illustrate "the potential benefit of incorporating standardized symptom burden evaluations into clinic visits, and targeting patients found to have higher symptom burdens for referrals to, or at least discussion of, the option of concurrent outpatient palliative care," she said.

Simply asking women whether they’d like outpatient help with their symptoms, a question included in the survey, proved to be an excellent screening method for appropriate referral.

Positive responses "really did highlight a group that had a much higher symptom burden across the board. It turns out that just asking a patient if they are interested in that referral does pretty much as good a job as any other categorization," Dr. Casey said.

She and her colleagues compared women aged less than 50 years to women over 70 and found a trend toward greater symptom burden in younger patients, although it reached statistical significance only for pain; 44% of women under 50 reported pain at or above level 4 severity, while that level of pain was reported by only 17% of women over 70 (P = .001).

No difference in symptom burden was found by cancer stage and no statistically significant difference by type of cancer, although there was a trend toward less pain and fatigue in endometrial cancer and less anxiety in cervical cancer.

"Not surprisingly, patients with no evidence of disease at the time of their visit had a lower symptom burden across the board," Dr. Casey said. Similarly, those under treatment had a greater burden of anxiety and fatigue and worse well-being.

A chronic pain history correlated with increased pain, fatigue, and depression. Patients with a history of depression or anxiety had greater anxiety and fatigue and a worse sense of well-being.

For instance, 66% of women with anxiety or depression histories reported fatigue; the prevalence was 45% among women without those histories (P = .016). About 60% with chronic pain histories reported depression; depression was reported by 30% of those without that history (P = .002).

Without the comparisons being adjusted, it’s possible younger patients were simply more likely to be on treatment at the time of the survey, or treated more aggressively. Perhaps older women were less likely to report symptoms.

"We just don’t know," Dr. Casey said.

Dr. Casey said she had no relevant financial disclosures.

VANCOUVER, B.C. – Gynecologic cancer symptoms may be more severe in younger women; in women with histories of anxiety, depression, and chronic pain; and in women on active treatment, according to survey results from the University of California, San Francisco.

The findings suggest that outpatient palliative care might best be targeted to women in those categories, said lead investigator Dr. Carolyn Casey, an ob.gyn. with the UCSF Helen Diller Family Comprehensive Cancer Center, San Francisco.

She cautioned against overinterpretation, however. The comparisons are unadjusted and simply correlations at this point. "They don’t speak to the ‘whys’ at all," she said.

The findings are important because outpatient palliative care is a newer field and not routinely offered in all cancer centers. Data are limited on who is most likely to benefit.

The handful of previous symptom studies in outpatient gynecologic cancer patients had fewer than 75 patients, and most women had ovarian cancer and were on chemotherapy.

Dr. Casey and her colleagues wanted a broader sample, so they gave Edmonton Symptom Assessment Scale (ESAS) surveys to 305 women in the gynecologic oncology waiting room over a 19-month period, asking them about symptoms during the previous week. The response rate to the survey is unknown at this point.

About 53% of respondents were between 50 and 70 years old, with 18% older and 29% younger; 46% had ovarian cancer, 37% endometrial cancer, and 17% cervical cancer.

The women were split fairly evenly between early- and late-stage disease and between being on and off treatment. Over a third had no evidence of cancer at the time of the survey. About 17% had histories of anxiety or depression, and 11% had chronic pain histories.

The survey asked women to rate pain, fatigue, anxiety, depression, and well-being on a 10-point scale, with 10 being worst. Severity scores of 4 or higher were considered clinically significant.

Thirty-two percent of the women reported clinically significant pain; 32%, depression; 45%, anxiety; and 47%, fatigue.

"We thought that was pretty high, especially in a population where over a third had no evidence of disease. It highlights a high symptom burden in this population that deserves attention," Dr. Casey said.

The findings also illustrate "the potential benefit of incorporating standardized symptom burden evaluations into clinic visits, and targeting patients found to have higher symptom burdens for referrals to, or at least discussion of, the option of concurrent outpatient palliative care," she said.

Simply asking women whether they’d like outpatient help with their symptoms, a question included in the survey, proved to be an excellent screening method for appropriate referral.

Positive responses "really did highlight a group that had a much higher symptom burden across the board. It turns out that just asking a patient if they are interested in that referral does pretty much as good a job as any other categorization," Dr. Casey said.

She and her colleagues compared women aged less than 50 years to women over 70 and found a trend toward greater symptom burden in younger patients, although it reached statistical significance only for pain; 44% of women under 50 reported pain at or above level 4 severity, while that level of pain was reported by only 17% of women over 70 (P = .001).

No difference in symptom burden was found by cancer stage and no statistically significant difference by type of cancer, although there was a trend toward less pain and fatigue in endometrial cancer and less anxiety in cervical cancer.

"Not surprisingly, patients with no evidence of disease at the time of their visit had a lower symptom burden across the board," Dr. Casey said. Similarly, those under treatment had a greater burden of anxiety and fatigue and worse well-being.

A chronic pain history correlated with increased pain, fatigue, and depression. Patients with a history of depression or anxiety had greater anxiety and fatigue and a worse sense of well-being.

For instance, 66% of women with anxiety or depression histories reported fatigue; the prevalence was 45% among women without those histories (P = .016). About 60% with chronic pain histories reported depression; depression was reported by 30% of those without that history (P = .002).

Without the comparisons being adjusted, it’s possible younger patients were simply more likely to be on treatment at the time of the survey, or treated more aggressively. Perhaps older women were less likely to report symptoms.

"We just don’t know," Dr. Casey said.

Dr. Casey said she had no relevant financial disclosures.

VANCOUVER, B.C. – Gynecologic cancer symptoms may be more severe in younger women; in women with histories of anxiety, depression, and chronic pain; and in women on active treatment, according to survey results from the University of California, San Francisco.

The findings suggest that outpatient palliative care might best be targeted to women in those categories, said lead investigator Dr. Carolyn Casey, an ob.gyn. with the UCSF Helen Diller Family Comprehensive Cancer Center, San Francisco.

She cautioned against overinterpretation, however. The comparisons are unadjusted and simply correlations at this point. "They don’t speak to the ‘whys’ at all," she said.

The findings are important because outpatient palliative care is a newer field and not routinely offered in all cancer centers. Data are limited on who is most likely to benefit.

The handful of previous symptom studies in outpatient gynecologic cancer patients had fewer than 75 patients, and most women had ovarian cancer and were on chemotherapy.

Dr. Casey and her colleagues wanted a broader sample, so they gave Edmonton Symptom Assessment Scale (ESAS) surveys to 305 women in the gynecologic oncology waiting room over a 19-month period, asking them about symptoms during the previous week. The response rate to the survey is unknown at this point.

About 53% of respondents were between 50 and 70 years old, with 18% older and 29% younger; 46% had ovarian cancer, 37% endometrial cancer, and 17% cervical cancer.

The women were split fairly evenly between early- and late-stage disease and between being on and off treatment. Over a third had no evidence of cancer at the time of the survey. About 17% had histories of anxiety or depression, and 11% had chronic pain histories.

The survey asked women to rate pain, fatigue, anxiety, depression, and well-being on a 10-point scale, with 10 being worst. Severity scores of 4 or higher were considered clinically significant.

Thirty-two percent of the women reported clinically significant pain; 32%, depression; 45%, anxiety; and 47%, fatigue.

"We thought that was pretty high, especially in a population where over a third had no evidence of disease. It highlights a high symptom burden in this population that deserves attention," Dr. Casey said.

The findings also illustrate "the potential benefit of incorporating standardized symptom burden evaluations into clinic visits, and targeting patients found to have higher symptom burdens for referrals to, or at least discussion of, the option of concurrent outpatient palliative care," she said.

Simply asking women whether they’d like outpatient help with their symptoms, a question included in the survey, proved to be an excellent screening method for appropriate referral.

Positive responses "really did highlight a group that had a much higher symptom burden across the board. It turns out that just asking a patient if they are interested in that referral does pretty much as good a job as any other categorization," Dr. Casey said.

She and her colleagues compared women aged less than 50 years to women over 70 and found a trend toward greater symptom burden in younger patients, although it reached statistical significance only for pain; 44% of women under 50 reported pain at or above level 4 severity, while that level of pain was reported by only 17% of women over 70 (P = .001).

No difference in symptom burden was found by cancer stage and no statistically significant difference by type of cancer, although there was a trend toward less pain and fatigue in endometrial cancer and less anxiety in cervical cancer.

"Not surprisingly, patients with no evidence of disease at the time of their visit had a lower symptom burden across the board," Dr. Casey said. Similarly, those under treatment had a greater burden of anxiety and fatigue and worse well-being.

A chronic pain history correlated with increased pain, fatigue, and depression. Patients with a history of depression or anxiety had greater anxiety and fatigue and a worse sense of well-being.

For instance, 66% of women with anxiety or depression histories reported fatigue; the prevalence was 45% among women without those histories (P = .016). About 60% with chronic pain histories reported depression; depression was reported by 30% of those without that history (P = .002).

Without the comparisons being adjusted, it’s possible younger patients were simply more likely to be on treatment at the time of the survey, or treated more aggressively. Perhaps older women were less likely to report symptoms.

"We just don’t know," Dr. Casey said.

Dr. Casey said she had no relevant financial disclosures.

VANCOUVER, B.C. – Gynecologic cancer symptoms may be more severe in younger women; in women with histories of anxiety, depression, and chronic pain; and in women on active treatment, according to survey results from the University of California, San Francisco.

The findings suggest that outpatient palliative care might best be targeted to women in those categories, said lead investigator Dr. Carolyn Casey, an ob.gyn. with the UCSF Helen Diller Family Comprehensive Cancer Center, San Francisco.

She cautioned against overinterpretation, however. The comparisons are unadjusted and simply correlations at this point. "They don’t speak to the ‘whys’ at all," she said.

The findings are important because outpatient palliative care is a newer field and not routinely offered in all cancer centers. Data are limited on who is most likely to benefit.

The handful of previous symptom studies in outpatient gynecologic cancer patients had fewer than 75 patients, and most women had ovarian cancer and were on chemotherapy.

Dr. Casey and her colleagues wanted a broader sample, so they gave Edmonton Symptom Assessment Scale (ESAS) surveys to 305 women in the gynecologic oncology waiting room over a 19-month period, asking them about symptoms during the previous week. The response rate to the survey is unknown at this point.

About 53% of respondents were between 50 and 70 years old, with 18% older and 29% younger; 46% had ovarian cancer, 37% endometrial cancer, and 17% cervical cancer.

The women were split fairly evenly between early- and late-stage disease and between being on and off treatment. Over a third had no evidence of cancer at the time of the survey. About 17% had histories of anxiety or depression, and 11% had chronic pain histories.

The survey asked women to rate pain, fatigue, anxiety, depression, and well-being on a 10-point scale, with 10 being worst. Severity scores of 4 or higher were considered clinically significant.

Thirty-two percent of the women reported clinically significant pain; 32%, depression; 45%, anxiety; and 47%, fatigue.

"We thought that was pretty high, especially in a population where over a third had no evidence of disease. It highlights a high symptom burden in this population that deserves attention," Dr. Casey said.

The findings also illustrate "the potential benefit of incorporating standardized symptom burden evaluations into clinic visits, and targeting patients found to have higher symptom burdens for referrals to, or at least discussion of, the option of concurrent outpatient palliative care," she said.

Simply asking women whether they’d like outpatient help with their symptoms, a question included in the survey, proved to be an excellent screening method for appropriate referral.

Positive responses "really did highlight a group that had a much higher symptom burden across the board. It turns out that just asking a patient if they are interested in that referral does pretty much as good a job as any other categorization," Dr. Casey said.

She and her colleagues compared women aged less than 50 years to women over 70 and found a trend toward greater symptom burden in younger patients, although it reached statistical significance only for pain; 44% of women under 50 reported pain at or above level 4 severity, while that level of pain was reported by only 17% of women over 70 (P = .001).

No difference in symptom burden was found by cancer stage and no statistically significant difference by type of cancer, although there was a trend toward less pain and fatigue in endometrial cancer and less anxiety in cervical cancer.

"Not surprisingly, patients with no evidence of disease at the time of their visit had a lower symptom burden across the board," Dr. Casey said. Similarly, those under treatment had a greater burden of anxiety and fatigue and worse well-being.

A chronic pain history correlated with increased pain, fatigue, and depression. Patients with a history of depression or anxiety had greater anxiety and fatigue and a worse sense of well-being.

For instance, 66% of women with anxiety or depression histories reported fatigue; the prevalence was 45% among women without those histories (P = .016). About 60% with chronic pain histories reported depression; depression was reported by 30% of those without that history (P = .002).

Without the comparisons being adjusted, it’s possible younger patients were simply more likely to be on treatment at the time of the survey, or treated more aggressively. Perhaps older women were less likely to report symptoms.

"We just don’t know," Dr. Casey said.

Dr. Casey said she had no relevant financial disclosures.

VANCOUVER, B.C. – Gynecologic cancer symptoms may be more severe in younger women; in women with histories of anxiety, depression, and chronic pain; and in women on active treatment, according to survey results from the University of California, San Francisco.

The findings suggest that outpatient palliative care might best be targeted to women in those categories, said lead investigator Dr. Carolyn Casey, an ob.gyn. with the UCSF Helen Diller Family Comprehensive Cancer Center, San Francisco.

She cautioned against overinterpretation, however. The comparisons are unadjusted and simply correlations at this point. "They don’t speak to the ‘whys’ at all," she said.

The findings are important because outpatient palliative care is a newer field and not routinely offered in all cancer centers. Data are limited on who is most likely to benefit.

The handful of previous symptom studies in outpatient gynecologic cancer patients had fewer than 75 patients, and most women had ovarian cancer and were on chemotherapy.

Dr. Casey and her colleagues wanted a broader sample, so they gave Edmonton Symptom Assessment Scale (ESAS) surveys to 305 women in the gynecologic oncology waiting room over a 19-month period, asking them about symptoms during the previous week. The response rate to the survey is unknown at this point.

About 53% of respondents were between 50 and 70 years old, with 18% older and 29% younger; 46% had ovarian cancer, 37% endometrial cancer, and 17% cervical cancer.

The women were split fairly evenly between early- and late-stage disease and between being on and off treatment. Over a third had no evidence of cancer at the time of the survey. About 17% had histories of anxiety or depression, and 11% had chronic pain histories.

The survey asked women to rate pain, fatigue, anxiety, depression, and well-being on a 10-point scale, with 10 being worst. Severity scores of 4 or higher were considered clinically significant.

Thirty-two percent of the women reported clinically significant pain; 32%, depression; 45%, anxiety; and 47%, fatigue.

"We thought that was pretty high, especially in a population where over a third had no evidence of disease. It highlights a high symptom burden in this population that deserves attention," Dr. Casey said.

The findings also illustrate "the potential benefit of incorporating standardized symptom burden evaluations into clinic visits, and targeting patients found to have higher symptom burdens for referrals to, or at least discussion of, the option of concurrent outpatient palliative care," she said.

Simply asking women whether they’d like outpatient help with their symptoms, a question included in the survey, proved to be an excellent screening method for appropriate referral.

Positive responses "really did highlight a group that had a much higher symptom burden across the board. It turns out that just asking a patient if they are interested in that referral does pretty much as good a job as any other categorization," Dr. Casey said.

She and her colleagues compared women aged less than 50 years to women over 70 and found a trend toward greater symptom burden in younger patients, although it reached statistical significance only for pain; 44% of women under 50 reported pain at or above level 4 severity, while that level of pain was reported by only 17% of women over 70 (P = .001).

No difference in symptom burden was found by cancer stage and no statistically significant difference by type of cancer, although there was a trend toward less pain and fatigue in endometrial cancer and less anxiety in cervical cancer.

"Not surprisingly, patients with no evidence of disease at the time of their visit had a lower symptom burden across the board," Dr. Casey said. Similarly, those under treatment had a greater burden of anxiety and fatigue and worse well-being.

A chronic pain history correlated with increased pain, fatigue, and depression. Patients with a history of depression or anxiety had greater anxiety and fatigue and a worse sense of well-being.

For instance, 66% of women with anxiety or depression histories reported fatigue; the prevalence was 45% among women without those histories (P = .016). About 60% with chronic pain histories reported depression; depression was reported by 30% of those without that history (P = .002).

Without the comparisons being adjusted, it’s possible younger patients were simply more likely to be on treatment at the time of the survey, or treated more aggressively. Perhaps older women were less likely to report symptoms.

"We just don’t know," Dr. Casey said.

Dr. Casey said she had no relevant financial disclosures.

VANCOUVER, B.C. – Gynecologic cancer symptoms may be more severe in younger women; in women with histories of anxiety, depression, and chronic pain; and in women on active treatment, according to survey results from the University of California, San Francisco.

The findings suggest that outpatient palliative care might best be targeted to women in those categories, said lead investigator Dr. Carolyn Casey, an ob.gyn. with the UCSF Helen Diller Family Comprehensive Cancer Center, San Francisco.

She cautioned against overinterpretation, however. The comparisons are unadjusted and simply correlations at this point. "They don’t speak to the ‘whys’ at all," she said.

The findings are important because outpatient palliative care is a newer field and not routinely offered in all cancer centers. Data are limited on who is most likely to benefit.

The handful of previous symptom studies in outpatient gynecologic cancer patients had fewer than 75 patients, and most women had ovarian cancer and were on chemotherapy.

Dr. Casey and her colleagues wanted a broader sample, so they gave Edmonton Symptom Assessment Scale (ESAS) surveys to 305 women in the gynecologic oncology waiting room over a 19-month period, asking them about symptoms during the previous week. The response rate to the survey is unknown at this point.

About 53% of respondents were between 50 and 70 years old, with 18% older and 29% younger; 46% had ovarian cancer, 37% endometrial cancer, and 17% cervical cancer.

The women were split fairly evenly between early- and late-stage disease and between being on and off treatment. Over a third had no evidence of cancer at the time of the survey. About 17% had histories of anxiety or depression, and 11% had chronic pain histories.

The survey asked women to rate pain, fatigue, anxiety, depression, and well-being on a 10-point scale, with 10 being worst. Severity scores of 4 or higher were considered clinically significant.

Thirty-two percent of the women reported clinically significant pain; 32%, depression; 45%, anxiety; and 47%, fatigue.

"We thought that was pretty high, especially in a population where over a third had no evidence of disease. It highlights a high symptom burden in this population that deserves attention," Dr. Casey said.

The findings also illustrate "the potential benefit of incorporating standardized symptom burden evaluations into clinic visits, and targeting patients found to have higher symptom burdens for referrals to, or at least discussion of, the option of concurrent outpatient palliative care," she said.

Simply asking women whether they’d like outpatient help with their symptoms, a question included in the survey, proved to be an excellent screening method for appropriate referral.

Positive responses "really did highlight a group that had a much higher symptom burden across the board. It turns out that just asking a patient if they are interested in that referral does pretty much as good a job as any other categorization," Dr. Casey said.

She and her colleagues compared women aged less than 50 years to women over 70 and found a trend toward greater symptom burden in younger patients, although it reached statistical significance only for pain; 44% of women under 50 reported pain at or above level 4 severity, while that level of pain was reported by only 17% of women over 70 (P = .001).

No difference in symptom burden was found by cancer stage and no statistically significant difference by type of cancer, although there was a trend toward less pain and fatigue in endometrial cancer and less anxiety in cervical cancer.

"Not surprisingly, patients with no evidence of disease at the time of their visit had a lower symptom burden across the board," Dr. Casey said. Similarly, those under treatment had a greater burden of anxiety and fatigue and worse well-being.

A chronic pain history correlated with increased pain, fatigue, and depression. Patients with a history of depression or anxiety had greater anxiety and fatigue and a worse sense of well-being.

For instance, 66% of women with anxiety or depression histories reported fatigue; the prevalence was 45% among women without those histories (P = .016). About 60% with chronic pain histories reported depression; depression was reported by 30% of those without that history (P = .002).

Without the comparisons being adjusted, it’s possible younger patients were simply more likely to be on treatment at the time of the survey, or treated more aggressively. Perhaps older women were less likely to report symptoms.

"We just don’t know," Dr. Casey said.

Dr. Casey said she had no relevant financial disclosures.

VANCOUVER, B.C. – Gynecologic cancer symptoms may be more severe in younger women; in women with histories of anxiety, depression, and chronic pain; and in women on active treatment, according to survey results from the University of California, San Francisco.

The findings suggest that outpatient palliative care might best be targeted to women in those categories, said lead investigator Dr. Carolyn Casey, an ob.gyn. with the UCSF Helen Diller Family Comprehensive Cancer Center, San Francisco.

She cautioned against overinterpretation, however. The comparisons are unadjusted and simply correlations at this point. "They don’t speak to the ‘whys’ at all," she said.

The findings are important because outpatient palliative care is a newer field and not routinely offered in all cancer centers. Data are limited on who is most likely to benefit.

The handful of previous symptom studies in outpatient gynecologic cancer patients had fewer than 75 patients, and most women had ovarian cancer and were on chemotherapy.

Dr. Casey and her colleagues wanted a broader sample, so they gave Edmonton Symptom Assessment Scale (ESAS) surveys to 305 women in the gynecologic oncology waiting room over a 19-month period, asking them about symptoms during the previous week. The response rate to the survey is unknown at this point.

About 53% of respondents were between 50 and 70 years old, with 18% older and 29% younger; 46% had ovarian cancer, 37% endometrial cancer, and 17% cervical cancer.

The women were split fairly evenly between early- and late-stage disease and between being on and off treatment. Over a third had no evidence of cancer at the time of the survey. About 17% had histories of anxiety or depression, and 11% had chronic pain histories.

The survey asked women to rate pain, fatigue, anxiety, depression, and well-being on a 10-point scale, with 10 being worst. Severity scores of 4 or higher were considered clinically significant.

Thirty-two percent of the women reported clinically significant pain; 32%, depression; 45%, anxiety; and 47%, fatigue.

"We thought that was pretty high, especially in a population where over a third had no evidence of disease. It highlights a high symptom burden in this population that deserves attention," Dr. Casey said.

The findings also illustrate "the potential benefit of incorporating standardized symptom burden evaluations into clinic visits, and targeting patients found to have higher symptom burdens for referrals to, or at least discussion of, the option of concurrent outpatient palliative care," she said.

Simply asking women whether they’d like outpatient help with their symptoms, a question included in the survey, proved to be an excellent screening method for appropriate referral.

Positive responses "really did highlight a group that had a much higher symptom burden across the board. It turns out that just asking a patient if they are interested in that referral does pretty much as good a job as any other categorization," Dr. Casey said.

She and her colleagues compared women aged less than 50 years to women over 70 and found a trend toward greater symptom burden in younger patients, although it reached statistical significance only for pain; 44% of women under 50 reported pain at or above level 4 severity, while that level of pain was reported by only 17% of women over 70 (P = .001).

No difference in symptom burden was found by cancer stage and no statistically significant difference by type of cancer, although there was a trend toward less pain and fatigue in endometrial cancer and less anxiety in cervical cancer.

"Not surprisingly, patients with no evidence of disease at the time of their visit had a lower symptom burden across the board," Dr. Casey said. Similarly, those under treatment had a greater burden of anxiety and fatigue and worse well-being.

A chronic pain history correlated with increased pain, fatigue, and depression. Patients with a history of depression or anxiety had greater anxiety and fatigue and a worse sense of well-being.

For instance, 66% of women with anxiety or depression histories reported fatigue; the prevalence was 45% among women without those histories (P = .016). About 60% with chronic pain histories reported depression; depression was reported by 30% of those without that history (P = .002).

Without the comparisons being adjusted, it’s possible younger patients were simply more likely to be on treatment at the time of the survey, or treated more aggressively. Perhaps older women were less likely to report symptoms.

"We just don’t know," Dr. Casey said.

Dr. Casey said she had no relevant financial disclosures.

SAN FRANCISCO – Baseline milk-IgE level and skin-prick wheal size do a good job of predicting if a child will outgrow a milk allergy, but variation in eczema severity does not, two studies have shown.

"If you have a low milk-specific IgE, less than 2 on the ImmunoCAP test, about [65%] of babies outgrow their allergy" by 30 months. "If you look at those with higher numbers, greater than 10, only 7% of those babies outgrow their allergy," said lead investigator Dr. Robert A. Wood, professor of pediatrics and chief of the division of allergy and immunology at Johns Hopkins Children’s Center, Baltimore.

In the eczema study, "what we found was that the more severe the eczema you had when you came into the study, the less chance of outgrowing your milk allergy," but reduction in eczema severity did not correlate with milk allergy resolution, said Dr. Wood, also an investigator on the second trial.

Being able to predict resolution is important not only to reassure parents and guide treatment, but also because immunotherapy desensitization techniques being developed by Dr. Wood and others may be widely available in 5 or 10 years.

"If we have a marker that says this child can do it on their own by the time they are 2½, that’s great. If we have a marker that says this child will have a lifetime milk allergy, and maybe [immunotherapy] will be most effective if we initiate it early, that will be an incredibly important piece of information," he said at the annual meeting of the American Academy of Allergy, Asthma, and Immunology.

Populations for both studies were drawn from the Consortium of Food Allergy Research (CoFAR) cohort, a National Institutes of Health–funded project with more than 500 children.

In the first study, 89 (36.5%) of 244 milk-allergic infants aged 3-15 months tolerated milk by month 30. The median age of resolution was 2 years.

Those who outgrew their allergy started the trial with a median baseline milk-IgE of 0.72 kU/L; those who did not started with a median of 6.99 kU/L. Only 14.2% of infants who entered the trial with IgE values at or above 5 kU/L resolved their allergy by month 30.

Also associated with resolution was a median baseline milk skin-prick wheal size of 5.0 mm. The median size of those who remained allergic was 9.25 mm (P = less than .001).

"You could really tell a mother with [a] 9-month old baby based on IgE and skin test that [there is a] possibility of outgrowing" the allergy within 30 months. Both are "very useful predictors," Dr. Wood said.

In the eczema study, 27 (46%) of 59 infants aged 3-15 months with mild eczema resolved their milk allergies within 2 years, while only 41 (25%) of 165 with moderate to severe eczema outgrew their allergy (P = .004).

However, in a finding that may surprise some allergists, just 12 (19%) of 62 children enrolled with moderate to severe eczema outgrew their allergy even though their eczema improved to none or mild; among 66 children whose eczema didn’t improve, 21 (32%) outgrew their allergy (P = .11).

"We saw kids whose eczema got a lot better who stayed allergic, and other kids whose eczema stayed severe who managed to outgrow their allergies," Dr. Wood said.

That’s surprising because "there’s just sort of an assumption that many allergists [have] that as atopic dermatitis [gets better, children] are more likely to outgrow their food allergy. What this study showed was there wasn’t that direct line," he said.

Dr. Wood and his colleagues also looked at egg allergy; 13 (39%) of 33 children with no or mild eczema at enrollment outgrew their egg allergy within 2 years, compared with 19 (21%) of 89 enrolled with moderate to severe eczema (P = .047).

About a quarter resolved their egg allergies whether their eczema improved or not, but the finding wasn’t statistically significant.

Dr. Wood said he had no relevant financial disclosures.

SAN FRANCISCO – Baseline milk-IgE level and skin-prick wheal size do a good job of predicting if a child will outgrow a milk allergy, but variation in eczema severity does not, two studies have shown.

"If you have a low milk-specific IgE, less than 2 on the ImmunoCAP test, about [65%] of babies outgrow their allergy" by 30 months. "If you look at those with higher numbers, greater than 10, only 7% of those babies outgrow their allergy," said lead investigator Dr. Robert A. Wood, professor of pediatrics and chief of the division of allergy and immunology at Johns Hopkins Children’s Center, Baltimore.

In the eczema study, "what we found was that the more severe the eczema you had when you came into the study, the less chance of outgrowing your milk allergy," but reduction in eczema severity did not correlate with milk allergy resolution, said Dr. Wood, also an investigator on the second trial.

Being able to predict resolution is important not only to reassure parents and guide treatment, but also because immunotherapy desensitization techniques being developed by Dr. Wood and others may be widely available in 5 or 10 years.

"If we have a marker that says this child can do it on their own by the time they are 2½, that’s great. If we have a marker that says this child will have a lifetime milk allergy, and maybe [immunotherapy] will be most effective if we initiate it early, that will be an incredibly important piece of information," he said at the annual meeting of the American Academy of Allergy, Asthma, and Immunology.

Populations for both studies were drawn from the Consortium of Food Allergy Research (CoFAR) cohort, a National Institutes of Health–funded project with more than 500 children.

In the first study, 89 (36.5%) of 244 milk-allergic infants aged 3-15 months tolerated milk by month 30. The median age of resolution was 2 years.

Those who outgrew their allergy started the trial with a median baseline milk-IgE of 0.72 kU/L; those who did not started with a median of 6.99 kU/L. Only 14.2% of infants who entered the trial with IgE values at or above 5 kU/L resolved their allergy by month 30.

Also associated with resolution was a median baseline milk skin-prick wheal size of 5.0 mm. The median size of those who remained allergic was 9.25 mm (P = less than .001).

"You could really tell a mother with [a] 9-month old baby based on IgE and skin test that [there is a] possibility of outgrowing" the allergy within 30 months. Both are "very useful predictors," Dr. Wood said.

In the eczema study, 27 (46%) of 59 infants aged 3-15 months with mild eczema resolved their milk allergies within 2 years, while only 41 (25%) of 165 with moderate to severe eczema outgrew their allergy (P = .004).

However, in a finding that may surprise some allergists, just 12 (19%) of 62 children enrolled with moderate to severe eczema outgrew their allergy even though their eczema improved to none or mild; among 66 children whose eczema didn’t improve, 21 (32%) outgrew their allergy (P = .11).

"We saw kids whose eczema got a lot better who stayed allergic, and other kids whose eczema stayed severe who managed to outgrow their allergies," Dr. Wood said.

That’s surprising because "there’s just sort of an assumption that many allergists [have] that as atopic dermatitis [gets better, children] are more likely to outgrow their food allergy. What this study showed was there wasn’t that direct line," he said.

Dr. Wood and his colleagues also looked at egg allergy; 13 (39%) of 33 children with no or mild eczema at enrollment outgrew their egg allergy within 2 years, compared with 19 (21%) of 89 enrolled with moderate to severe eczema (P = .047).

About a quarter resolved their egg allergies whether their eczema improved or not, but the finding wasn’t statistically significant.

Dr. Wood said he had no relevant financial disclosures.

SAN FRANCISCO – Baseline milk-IgE level and skin-prick wheal size do a good job of predicting if a child will outgrow a milk allergy, but variation in eczema severity does not, two studies have shown.

"If you have a low milk-specific IgE, less than 2 on the ImmunoCAP test, about [65%] of babies outgrow their allergy" by 30 months. "If you look at those with higher numbers, greater than 10, only 7% of those babies outgrow their allergy," said lead investigator Dr. Robert A. Wood, professor of pediatrics and chief of the division of allergy and immunology at Johns Hopkins Children’s Center, Baltimore.

In the eczema study, "what we found was that the more severe the eczema you had when you came into the study, the less chance of outgrowing your milk allergy," but reduction in eczema severity did not correlate with milk allergy resolution, said Dr. Wood, also an investigator on the second trial.

Being able to predict resolution is important not only to reassure parents and guide treatment, but also because immunotherapy desensitization techniques being developed by Dr. Wood and others may be widely available in 5 or 10 years.

"If we have a marker that says this child can do it on their own by the time they are 2½, that’s great. If we have a marker that says this child will have a lifetime milk allergy, and maybe [immunotherapy] will be most effective if we initiate it early, that will be an incredibly important piece of information," he said at the annual meeting of the American Academy of Allergy, Asthma, and Immunology.

Populations for both studies were drawn from the Consortium of Food Allergy Research (CoFAR) cohort, a National Institutes of Health–funded project with more than 500 children.

In the first study, 89 (36.5%) of 244 milk-allergic infants aged 3-15 months tolerated milk by month 30. The median age of resolution was 2 years.

Those who outgrew their allergy started the trial with a median baseline milk-IgE of 0.72 kU/L; those who did not started with a median of 6.99 kU/L. Only 14.2% of infants who entered the trial with IgE values at or above 5 kU/L resolved their allergy by month 30.

Also associated with resolution was a median baseline milk skin-prick wheal size of 5.0 mm. The median size of those who remained allergic was 9.25 mm (P = less than .001).

"You could really tell a mother with [a] 9-month old baby based on IgE and skin test that [there is a] possibility of outgrowing" the allergy within 30 months. Both are "very useful predictors," Dr. Wood said.

In the eczema study, 27 (46%) of 59 infants aged 3-15 months with mild eczema resolved their milk allergies within 2 years, while only 41 (25%) of 165 with moderate to severe eczema outgrew their allergy (P = .004).

However, in a finding that may surprise some allergists, just 12 (19%) of 62 children enrolled with moderate to severe eczema outgrew their allergy even though their eczema improved to none or mild; among 66 children whose eczema didn’t improve, 21 (32%) outgrew their allergy (P = .11).

"We saw kids whose eczema got a lot better who stayed allergic, and other kids whose eczema stayed severe who managed to outgrow their allergies," Dr. Wood said.

That’s surprising because "there’s just sort of an assumption that many allergists [have] that as atopic dermatitis [gets better, children] are more likely to outgrow their food allergy. What this study showed was there wasn’t that direct line," he said.

Dr. Wood and his colleagues also looked at egg allergy; 13 (39%) of 33 children with no or mild eczema at enrollment outgrew their egg allergy within 2 years, compared with 19 (21%) of 89 enrolled with moderate to severe eczema (P = .047).

About a quarter resolved their egg allergies whether their eczema improved or not, but the finding wasn’t statistically significant.

Dr. Wood said he had no relevant financial disclosures.

SAN FRANCISCO – Baseline milk-IgE level and skin-prick wheal size do a good job of predicting if a child will outgrow a milk allergy, but variation in eczema severity does not, two studies have shown.

"If you have a low milk-specific IgE, less than 2 on the ImmunoCAP test, about [65%] of babies outgrow their allergy" by 30 months. "If you look at those with higher numbers, greater than 10, only 7% of those babies outgrow their allergy," said lead investigator Dr. Robert A. Wood, professor of pediatrics and chief of the division of allergy and immunology at Johns Hopkins Children’s Center, Baltimore.

In the eczema study, "what we found was that the more severe the eczema you had when you came into the study, the less chance of outgrowing your milk allergy," but reduction in eczema severity did not correlate with milk allergy resolution, said Dr. Wood, also an investigator on the second trial.

Being able to predict resolution is important not only to reassure parents and guide treatment, but also because immunotherapy desensitization techniques being developed by Dr. Wood and others may be widely available in 5 or 10 years.

"If we have a marker that says this child can do it on their own by the time they are 2½, that’s great. If we have a marker that says this child will have a lifetime milk allergy, and maybe [immunotherapy] will be most effective if we initiate it early, that will be an incredibly important piece of information," he said at the annual meeting of the American Academy of Allergy, Asthma, and Immunology.

Populations for both studies were drawn from the Consortium of Food Allergy Research (CoFAR) cohort, a National Institutes of Health–funded project with more than 500 children.

In the first study, 89 (36.5%) of 244 milk-allergic infants aged 3-15 months tolerated milk by month 30. The median age of resolution was 2 years.

Those who outgrew their allergy started the trial with a median baseline milk-IgE of 0.72 kU/L; those who did not started with a median of 6.99 kU/L. Only 14.2% of infants who entered the trial with IgE values at or above 5 kU/L resolved their allergy by month 30.

Also associated with resolution was a median baseline milk skin-prick wheal size of 5.0 mm. The median size of those who remained allergic was 9.25 mm (P = less than .001).

"You could really tell a mother with [a] 9-month old baby based on IgE and skin test that [there is a] possibility of outgrowing" the allergy within 30 months. Both are "very useful predictors," Dr. Wood said.

In the eczema study, 27 (46%) of 59 infants aged 3-15 months with mild eczema resolved their milk allergies within 2 years, while only 41 (25%) of 165 with moderate to severe eczema outgrew their allergy (P = .004).

However, in a finding that may surprise some allergists, just 12 (19%) of 62 children enrolled with moderate to severe eczema outgrew their allergy even though their eczema improved to none or mild; among 66 children whose eczema didn’t improve, 21 (32%) outgrew their allergy (P = .11).

"We saw kids whose eczema got a lot better who stayed allergic, and other kids whose eczema stayed severe who managed to outgrow their allergies," Dr. Wood said.

That’s surprising because "there’s just sort of an assumption that many allergists [have] that as atopic dermatitis [gets better, children] are more likely to outgrow their food allergy. What this study showed was there wasn’t that direct line," he said.

Dr. Wood and his colleagues also looked at egg allergy; 13 (39%) of 33 children with no or mild eczema at enrollment outgrew their egg allergy within 2 years, compared with 19 (21%) of 89 enrolled with moderate to severe eczema (P = .047).

About a quarter resolved their egg allergies whether their eczema improved or not, but the finding wasn’t statistically significant.

Dr. Wood said he had no relevant financial disclosures.

SAN FRANCISCO – Baseline milk-IgE level and skin-prick wheal size do a good job of predicting if a child will outgrow a milk allergy, but variation in eczema severity does not, two studies have shown.

"If you have a low milk-specific IgE, less than 2 on the ImmunoCAP test, about [65%] of babies outgrow their allergy" by 30 months. "If you look at those with higher numbers, greater than 10, only 7% of those babies outgrow their allergy," said lead investigator Dr. Robert A. Wood, professor of pediatrics and chief of the division of allergy and immunology at Johns Hopkins Children’s Center, Baltimore.

In the eczema study, "what we found was that the more severe the eczema you had when you came into the study, the less chance of outgrowing your milk allergy," but reduction in eczema severity did not correlate with milk allergy resolution, said Dr. Wood, also an investigator on the second trial.

Being able to predict resolution is important not only to reassure parents and guide treatment, but also because immunotherapy desensitization techniques being developed by Dr. Wood and others may be widely available in 5 or 10 years.

"If we have a marker that says this child can do it on their own by the time they are 2½, that’s great. If we have a marker that says this child will have a lifetime milk allergy, and maybe [immunotherapy] will be most effective if we initiate it early, that will be an incredibly important piece of information," he said at the annual meeting of the American Academy of Allergy, Asthma, and Immunology.

Populations for both studies were drawn from the Consortium of Food Allergy Research (CoFAR) cohort, a National Institutes of Health–funded project with more than 500 children.

In the first study, 89 (36.5%) of 244 milk-allergic infants aged 3-15 months tolerated milk by month 30. The median age of resolution was 2 years.

Those who outgrew their allergy started the trial with a median baseline milk-IgE of 0.72 kU/L; those who did not started with a median of 6.99 kU/L. Only 14.2% of infants who entered the trial with IgE values at or above 5 kU/L resolved their allergy by month 30.

Also associated with resolution was a median baseline milk skin-prick wheal size of 5.0 mm. The median size of those who remained allergic was 9.25 mm (P = less than .001).

"You could really tell a mother with [a] 9-month old baby based on IgE and skin test that [there is a] possibility of outgrowing" the allergy within 30 months. Both are "very useful predictors," Dr. Wood said.

In the eczema study, 27 (46%) of 59 infants aged 3-15 months with mild eczema resolved their milk allergies within 2 years, while only 41 (25%) of 165 with moderate to severe eczema outgrew their allergy (P = .004).

However, in a finding that may surprise some allergists, just 12 (19%) of 62 children enrolled with moderate to severe eczema outgrew their allergy even though their eczema improved to none or mild; among 66 children whose eczema didn’t improve, 21 (32%) outgrew their allergy (P = .11).

"We saw kids whose eczema got a lot better who stayed allergic, and other kids whose eczema stayed severe who managed to outgrow their allergies," Dr. Wood said.

That’s surprising because "there’s just sort of an assumption that many allergists [have] that as atopic dermatitis [gets better, children] are more likely to outgrow their food allergy. What this study showed was there wasn’t that direct line," he said.

Dr. Wood and his colleagues also looked at egg allergy; 13 (39%) of 33 children with no or mild eczema at enrollment outgrew their egg allergy within 2 years, compared with 19 (21%) of 89 enrolled with moderate to severe eczema (P = .047).

About a quarter resolved their egg allergies whether their eczema improved or not, but the finding wasn’t statistically significant.

Dr. Wood said he had no relevant financial disclosures.

SAN FRANCISCO – Baseline milk-IgE level and skin-prick wheal size do a good job of predicting if a child will outgrow a milk allergy, but variation in eczema severity does not, two studies have shown.

"If you have a low milk-specific IgE, less than 2 on the ImmunoCAP test, about [65%] of babies outgrow their allergy" by 30 months. "If you look at those with higher numbers, greater than 10, only 7% of those babies outgrow their allergy," said lead investigator Dr. Robert A. Wood, professor of pediatrics and chief of the division of allergy and immunology at Johns Hopkins Children’s Center, Baltimore.

In the eczema study, "what we found was that the more severe the eczema you had when you came into the study, the less chance of outgrowing your milk allergy," but reduction in eczema severity did not correlate with milk allergy resolution, said Dr. Wood, also an investigator on the second trial.

Being able to predict resolution is important not only to reassure parents and guide treatment, but also because immunotherapy desensitization techniques being developed by Dr. Wood and others may be widely available in 5 or 10 years.

"If we have a marker that says this child can do it on their own by the time they are 2½, that’s great. If we have a marker that says this child will have a lifetime milk allergy, and maybe [immunotherapy] will be most effective if we initiate it early, that will be an incredibly important piece of information," he said at the annual meeting of the American Academy of Allergy, Asthma, and Immunology.

Populations for both studies were drawn from the Consortium of Food Allergy Research (CoFAR) cohort, a National Institutes of Health–funded project with more than 500 children.

In the first study, 89 (36.5%) of 244 milk-allergic infants aged 3-15 months tolerated milk by month 30. The median age of resolution was 2 years.

Those who outgrew their allergy started the trial with a median baseline milk-IgE of 0.72 kU/L; those who did not started with a median of 6.99 kU/L. Only 14.2% of infants who entered the trial with IgE values at or above 5 kU/L resolved their allergy by month 30.

Also associated with resolution was a median baseline milk skin-prick wheal size of 5.0 mm. The median size of those who remained allergic was 9.25 mm (P = less than .001).

"You could really tell a mother with [a] 9-month old baby based on IgE and skin test that [there is a] possibility of outgrowing" the allergy within 30 months. Both are "very useful predictors," Dr. Wood said.

In the eczema study, 27 (46%) of 59 infants aged 3-15 months with mild eczema resolved their milk allergies within 2 years, while only 41 (25%) of 165 with moderate to severe eczema outgrew their allergy (P = .004).

However, in a finding that may surprise some allergists, just 12 (19%) of 62 children enrolled with moderate to severe eczema outgrew their allergy even though their eczema improved to none or mild; among 66 children whose eczema didn’t improve, 21 (32%) outgrew their allergy (P = .11).

"We saw kids whose eczema got a lot better who stayed allergic, and other kids whose eczema stayed severe who managed to outgrow their allergies," Dr. Wood said.

That’s surprising because "there’s just sort of an assumption that many allergists [have] that as atopic dermatitis [gets better, children] are more likely to outgrow their food allergy. What this study showed was there wasn’t that direct line," he said.

Dr. Wood and his colleagues also looked at egg allergy; 13 (39%) of 33 children with no or mild eczema at enrollment outgrew their egg allergy within 2 years, compared with 19 (21%) of 89 enrolled with moderate to severe eczema (P = .047).

About a quarter resolved their egg allergies whether their eczema improved or not, but the finding wasn’t statistically significant.

Dr. Wood said he had no relevant financial disclosures.

SAN FRANCISCO – Oral immunotherapy bested sublingual immunotherapy for pediatric milk allergies in the first head-to-head comparison of the two desensitization techniques.

"The results are quite striking in that we found that both groups had significant increases in the amount of milk they could tolerate, but the oral immunotherapy group had a far greater increase," said senior investigator Dr. Robert A. Wood, professor of pediatrics and chief of the division of allergy and immunology at Johns Hopkins Children’s Center, Baltimore, Md.

However, oral therapy – in which powdered milk extract is put in food and taken as a daily treatment – had more frequent adverse events.

Twelve girls and eighteen boys aged 6-17 years participated in the trial. At baseline, they reacted to less than half a teaspoon of milk and had a median baseline milk-IgE of 37.8 kUa/L, with a range 1.1-572 kUa/L.

Ten randomized to sublingual therapy were gradually escalated to maintenance doses of 7 mg of milk extract per day placed under their tongues, held for a few minutes, then swallowed.

Ten children in the oral group were gradually escalated to daily maintenance doses of 1,000 mg, ten others to 2,000 mg.

One girl dropped out because she had a severe eczema flair, but the others reached the maintenance dose and completed milk challenges.

After 3 months of maintenance, children in the sublingual group tolerated a median of 940 mg of milk – a little less than an ounce – with a range of 40-8,140 mg.

Children in the 1,000 mg oral group tolerated a median of 6,140 mg with a range of 2,540-8,140 mg. Those in the 2,000 mg group tolerated 8,140 mg of milk with a range of 4,140-8,140 mg. The findings were statistically significant.

Six children in the sublingual group repeated the challenge at 14 months; one tolerated 8,000 mg, but the rest tolerated less than 1,000 mg and were switched to oral therapy, Dr. Wood said.

Skin prick tests decreased and milk-IgG4 increased in all the groups. Milk-IgE decreased only after oral immunotherapy. Milk-IgE or milk-IgG4 did not predict food challenge outcomes.

Side effects were similar between the sublingual and oral groups, but more severe in the oral groups. Antihistamines were needed with only about 1% of the sublingual doses, but with 18% of the oral doses. Epinephrine was used twice during sublingual therapy but four times during oral therapy.

Oral therapy’s greater side effects didn’t surprise coinvestigator Dr. Wesley Burks, chief of the division of pediatric allergy and immunology at Duke University Medical Center, Durham, N.C.

"In general, oral has more side effects." In immunotherapy trials, "about 15% of children cannot tolerate the procedure at all. They have too many [gastrointestinal] symptoms," he said.

Although promising, Dr. Wood noted the results are preliminary.

His study, as well as immunotherapy trials for peanuts and other allergens, have "very small numbers where we are trying to figure out the right doses and right way to do it. We are hopeful in the next few years we will be comfortable enough with the approach to be able to do some larger studies," he said.

Dr. Wood said he had no relevant financial disclosures. Dr. Burks disclosed that he is a consultant for Actogenix, Dannon, Intelliject, McNeil Nutritionals, Novartis, Schering-Plough (now part of Merck), and Nutricia. He is a minority stockholder in Allertein Therapeutics and Mast Cell Pharmaceuticals Inc. 

SAN FRANCISCO – Oral immunotherapy bested sublingual immunotherapy for pediatric milk allergies in the first head-to-head comparison of the two desensitization techniques.

"The results are quite striking in that we found that both groups had significant increases in the amount of milk they could tolerate, but the oral immunotherapy group had a far greater increase," said senior investigator Dr. Robert A. Wood, professor of pediatrics and chief of the division of allergy and immunology at Johns Hopkins Children’s Center, Baltimore, Md.

However, oral therapy – in which powdered milk extract is put in food and taken as a daily treatment – had more frequent adverse events.

Twelve girls and eighteen boys aged 6-17 years participated in the trial. At baseline, they reacted to less than half a teaspoon of milk and had a median baseline milk-IgE of 37.8 kUa/L, with a range 1.1-572 kUa/L.

Ten randomized to sublingual therapy were gradually escalated to maintenance doses of 7 mg of milk extract per day placed under their tongues, held for a few minutes, then swallowed.

Ten children in the oral group were gradually escalated to daily maintenance doses of 1,000 mg, ten others to 2,000 mg.

One girl dropped out because she had a severe eczema flair, but the others reached the maintenance dose and completed milk challenges.

After 3 months of maintenance, children in the sublingual group tolerated a median of 940 mg of milk – a little less than an ounce – with a range of 40-8,140 mg.

Children in the 1,000 mg oral group tolerated a median of 6,140 mg with a range of 2,540-8,140 mg. Those in the 2,000 mg group tolerated 8,140 mg of milk with a range of 4,140-8,140 mg. The findings were statistically significant.

Six children in the sublingual group repeated the challenge at 14 months; one tolerated 8,000 mg, but the rest tolerated less than 1,000 mg and were switched to oral therapy, Dr. Wood said.

Skin prick tests decreased and milk-IgG4 increased in all the groups. Milk-IgE decreased only after oral immunotherapy. Milk-IgE or milk-IgG4 did not predict food challenge outcomes.

Side effects were similar between the sublingual and oral groups, but more severe in the oral groups. Antihistamines were needed with only about 1% of the sublingual doses, but with 18% of the oral doses. Epinephrine was used twice during sublingual therapy but four times during oral therapy.

Oral therapy’s greater side effects didn’t surprise coinvestigator Dr. Wesley Burks, chief of the division of pediatric allergy and immunology at Duke University Medical Center, Durham, N.C.

"In general, oral has more side effects." In immunotherapy trials, "about 15% of children cannot tolerate the procedure at all. They have too many [gastrointestinal] symptoms," he said.

Although promising, Dr. Wood noted the results are preliminary.

His study, as well as immunotherapy trials for peanuts and other allergens, have "very small numbers where we are trying to figure out the right doses and right way to do it. We are hopeful in the next few years we will be comfortable enough with the approach to be able to do some larger studies," he said.

Dr. Wood said he had no relevant financial disclosures. Dr. Burks disclosed that he is a consultant for Actogenix, Dannon, Intelliject, McNeil Nutritionals, Novartis, Schering-Plough (now part of Merck), and Nutricia. He is a minority stockholder in Allertein Therapeutics and Mast Cell Pharmaceuticals Inc. 

SAN FRANCISCO – Oral immunotherapy bested sublingual immunotherapy for pediatric milk allergies in the first head-to-head comparison of the two desensitization techniques.

"The results are quite striking in that we found that both groups had significant increases in the amount of milk they could tolerate, but the oral immunotherapy group had a far greater increase," said senior investigator Dr. Robert A. Wood, professor of pediatrics and chief of the division of allergy and immunology at Johns Hopkins Children’s Center, Baltimore, Md.

However, oral therapy – in which powdered milk extract is put in food and taken as a daily treatment – had more frequent adverse events.

Twelve girls and eighteen boys aged 6-17 years participated in the trial. At baseline, they reacted to less than half a teaspoon of milk and had a median baseline milk-IgE of 37.8 kUa/L, with a range 1.1-572 kUa/L.

Ten randomized to sublingual therapy were gradually escalated to maintenance doses of 7 mg of milk extract per day placed under their tongues, held for a few minutes, then swallowed.

Ten children in the oral group were gradually escalated to daily maintenance doses of 1,000 mg, ten others to 2,000 mg.

One girl dropped out because she had a severe eczema flair, but the others reached the maintenance dose and completed milk challenges.

After 3 months of maintenance, children in the sublingual group tolerated a median of 940 mg of milk – a little less than an ounce – with a range of 40-8,140 mg.

Children in the 1,000 mg oral group tolerated a median of 6,140 mg with a range of 2,540-8,140 mg. Those in the 2,000 mg group tolerated 8,140 mg of milk with a range of 4,140-8,140 mg. The findings were statistically significant.

Six children in the sublingual group repeated the challenge at 14 months; one tolerated 8,000 mg, but the rest tolerated less than 1,000 mg and were switched to oral therapy, Dr. Wood said.

Skin prick tests decreased and milk-IgG4 increased in all the groups. Milk-IgE decreased only after oral immunotherapy. Milk-IgE or milk-IgG4 did not predict food challenge outcomes.

Side effects were similar between the sublingual and oral groups, but more severe in the oral groups. Antihistamines were needed with only about 1% of the sublingual doses, but with 18% of the oral doses. Epinephrine was used twice during sublingual therapy but four times during oral therapy.

Oral therapy’s greater side effects didn’t surprise coinvestigator Dr. Wesley Burks, chief of the division of pediatric allergy and immunology at Duke University Medical Center, Durham, N.C.

"In general, oral has more side effects." In immunotherapy trials, "about 15% of children cannot tolerate the procedure at all. They have too many [gastrointestinal] symptoms," he said.

Although promising, Dr. Wood noted the results are preliminary.

His study, as well as immunotherapy trials for peanuts and other allergens, have "very small numbers where we are trying to figure out the right doses and right way to do it. We are hopeful in the next few years we will be comfortable enough with the approach to be able to do some larger studies," he said.

Dr. Wood said he had no relevant financial disclosures. Dr. Burks disclosed that he is a consultant for Actogenix, Dannon, Intelliject, McNeil Nutritionals, Novartis, Schering-Plough (now part of Merck), and Nutricia. He is a minority stockholder in Allertein Therapeutics and Mast Cell Pharmaceuticals Inc.