Sara Freeman

LONDON – A home digital pregnancy test is able to correctly estimate the likely week of conception, according to the results of a 10-month, prospective observational study of 1,505 nonpregnant U.S. women.

"There was a high [98%] level of agreement between the digital pregnancy test and standardized ultrasound," Sarah Johnson, Ph.D., said in an interview at the annual meeting of the European Society of Human Reproduction and Embryology.

The results of the digital pregnancy test were compared with ultrasound measurements performed at approximately 12 weeks after the woman had her last menstrual period (LMP).

"We received clearance from the Food and Drug Administration last December, and all being well it should be on the shelves in September," said Dr. Johnson, who is a scientific and medical affairs manager for SPD Development of Bedford, England. The digital pregnancy test is already available in the United Kingdom* based on data from a previous study (Curr. Med. Res. Opin. 2011;27:393-401).

Dr. Johnson noted that this is the first home pregnancy test to provide an accurate and early assessment of pregnancy at the time when a woman first suspects that she might be pregnant. It is also the first test to provide a digital readout, which is potentially simpler for women to understand than seeing a line in a window to indicate whether they are pregnant or not.

Similar to other home pregnancy tests, the digital pregnancy test measures levels of human chorionic gonadotrophin (hCG) excreted in the urine. Measuring hCG is a tried-and-tested method of confirming pregnancy as the hormone plays a critical role in early pregnancy, helping with the implantation of the embryo and preventing further oocyte development.

Unlike existing tests, however, the digital pregnancy test estimates the time since conception based on thresholds of hCG, which have been shown to rise rapidly after ovulation has occurred, and measurement of this hormone in the urine reflects the duration of pregnancy (Curr. Med. Res. Opin. 2009;25:741-8).

In using the digital home pregnancy test, the woman can either hold the test strip in the urine stream for 5 seconds or dip it into a urine sample collected in a clean container for 20 seconds. Results from the test are then given in a few minutes as a digital readout saying if the woman is "pregnant" or "not pregnant," with additional numbers displayed if conception was likely to be 1-2, 2-3, or 3+ weeks ago.

During the study, women were required to provide urine samples every day throughout their menstrual cycles, a random sample of which were then tested in the laboratory using the digital home pregnancy test.

A total of 250 women became pregnant during the study, with sufficient data on 153 women available for analysis. All of these women had ultrasound performed at approximately 11-13 weeks of their pregnancy to determine the gestational age according to the crown rump length measurement. More than 3,600 digital pregnancy tests were preformed in three batches, with the technicians blinded to the samples.

One of the interesting observations of the study is the inaccuracy of the LMP, Dr. Johnson said. All the women in the study planned on becoming pregnant and were carefully monitoring their menstrual cycles. Although they thought they knew exactly when their LMP was, the urine assessments suggested they were wrong by about 5 days.

"When a woman thinks she is pregnant, all she has is her last menstrual period, and that in so many cases is wrong, so this new test provides something that can provide greater accuracy," Dr. Johnson suggested.

SPD Development also has a digital ovulation test that is soon to be released in both the United States and the United Kingdom.

"Normal ovulation tests just measure luteinizing hormone [LH], so they tell you the best 2 days [to conceive]," Dr. Johnson said. The digital ovulation test still measures the LH surge, which indicates ovulation has occurred, but it also measures levels of estrone-3-glucuronide (E3G), which is a major urinary metabolite of estradiol. Levels of E3G rise a couple of days before the LH surge.

"By measuring [E3G], you are actually telling a woman about those additional fertile days during which she can also get pregnant before the 2 peak days," Dr. Johnson explained. Data presented in a poster at the annual meeting of ESHRE showed that the new digital ovulation test identified 4 or more fertile days in 80% of menstrual cycles.

The digital ovulation test will come as a kit with replaceable test strips. A woman urinates on the test strip, puts it into the reader, and the device then remembers the result and helps the woman identify her most fertile period.

The study was funded by SPD Development. Dr. Johnson is an employee of the company, which manufactures the Clearblue Digital Pregnancy Test With Conception Indicator and the Clearblue Digital Ovulation Test With Dual Hormone Indicator.

*Correction, 7/18/2013: An earlier version of this story misstated the availability of the test.

LONDON – A home digital pregnancy test is able to correctly estimate the likely week of conception, according to the results of a 10-month, prospective observational study of 1,505 nonpregnant U.S. women.

"There was a high [98%] level of agreement between the digital pregnancy test and standardized ultrasound," Sarah Johnson, Ph.D., said in an interview at the annual meeting of the European Society of Human Reproduction and Embryology.

The results of the digital pregnancy test were compared with ultrasound measurements performed at approximately 12 weeks after the woman had her last menstrual period (LMP).

"We received clearance from the Food and Drug Administration last December, and all being well it should be on the shelves in September," said Dr. Johnson, who is a scientific and medical affairs manager for SPD Development of Bedford, England. The digital pregnancy test is already available in the United Kingdom* based on data from a previous study (Curr. Med. Res. Opin. 2011;27:393-401).

Dr. Johnson noted that this is the first home pregnancy test to provide an accurate and early assessment of pregnancy at the time when a woman first suspects that she might be pregnant. It is also the first test to provide a digital readout, which is potentially simpler for women to understand than seeing a line in a window to indicate whether they are pregnant or not.

Similar to other home pregnancy tests, the digital pregnancy test measures levels of human chorionic gonadotrophin (hCG) excreted in the urine. Measuring hCG is a tried-and-tested method of confirming pregnancy as the hormone plays a critical role in early pregnancy, helping with the implantation of the embryo and preventing further oocyte development.

Unlike existing tests, however, the digital pregnancy test estimates the time since conception based on thresholds of hCG, which have been shown to rise rapidly after ovulation has occurred, and measurement of this hormone in the urine reflects the duration of pregnancy (Curr. Med. Res. Opin. 2009;25:741-8).

In using the digital home pregnancy test, the woman can either hold the test strip in the urine stream for 5 seconds or dip it into a urine sample collected in a clean container for 20 seconds. Results from the test are then given in a few minutes as a digital readout saying if the woman is "pregnant" or "not pregnant," with additional numbers displayed if conception was likely to be 1-2, 2-3, or 3+ weeks ago.

During the study, women were required to provide urine samples every day throughout their menstrual cycles, a random sample of which were then tested in the laboratory using the digital home pregnancy test.

A total of 250 women became pregnant during the study, with sufficient data on 153 women available for analysis. All of these women had ultrasound performed at approximately 11-13 weeks of their pregnancy to determine the gestational age according to the crown rump length measurement. More than 3,600 digital pregnancy tests were preformed in three batches, with the technicians blinded to the samples.

One of the interesting observations of the study is the inaccuracy of the LMP, Dr. Johnson said. All the women in the study planned on becoming pregnant and were carefully monitoring their menstrual cycles. Although they thought they knew exactly when their LMP was, the urine assessments suggested they were wrong by about 5 days.

"When a woman thinks she is pregnant, all she has is her last menstrual period, and that in so many cases is wrong, so this new test provides something that can provide greater accuracy," Dr. Johnson suggested.

SPD Development also has a digital ovulation test that is soon to be released in both the United States and the United Kingdom.

"Normal ovulation tests just measure luteinizing hormone [LH], so they tell you the best 2 days [to conceive]," Dr. Johnson said. The digital ovulation test still measures the LH surge, which indicates ovulation has occurred, but it also measures levels of estrone-3-glucuronide (E3G), which is a major urinary metabolite of estradiol. Levels of E3G rise a couple of days before the LH surge.

"By measuring [E3G], you are actually telling a woman about those additional fertile days during which she can also get pregnant before the 2 peak days," Dr. Johnson explained. Data presented in a poster at the annual meeting of ESHRE showed that the new digital ovulation test identified 4 or more fertile days in 80% of menstrual cycles.

The digital ovulation test will come as a kit with replaceable test strips. A woman urinates on the test strip, puts it into the reader, and the device then remembers the result and helps the woman identify her most fertile period.

The study was funded by SPD Development. Dr. Johnson is an employee of the company, which manufactures the Clearblue Digital Pregnancy Test With Conception Indicator and the Clearblue Digital Ovulation Test With Dual Hormone Indicator.

*Correction, 7/18/2013: An earlier version of this story misstated the availability of the test.

LONDON – A home digital pregnancy test is able to correctly estimate the likely week of conception, according to the results of a 10-month, prospective observational study of 1,505 nonpregnant U.S. women.

"There was a high [98%] level of agreement between the digital pregnancy test and standardized ultrasound," Sarah Johnson, Ph.D., said in an interview at the annual meeting of the European Society of Human Reproduction and Embryology.

The results of the digital pregnancy test were compared with ultrasound measurements performed at approximately 12 weeks after the woman had her last menstrual period (LMP).

"We received clearance from the Food and Drug Administration last December, and all being well it should be on the shelves in September," said Dr. Johnson, who is a scientific and medical affairs manager for SPD Development of Bedford, England. The digital pregnancy test is already available in the United Kingdom* based on data from a previous study (Curr. Med. Res. Opin. 2011;27:393-401).

Dr. Johnson noted that this is the first home pregnancy test to provide an accurate and early assessment of pregnancy at the time when a woman first suspects that she might be pregnant. It is also the first test to provide a digital readout, which is potentially simpler for women to understand than seeing a line in a window to indicate whether they are pregnant or not.

Similar to other home pregnancy tests, the digital pregnancy test measures levels of human chorionic gonadotrophin (hCG) excreted in the urine. Measuring hCG is a tried-and-tested method of confirming pregnancy as the hormone plays a critical role in early pregnancy, helping with the implantation of the embryo and preventing further oocyte development.

Unlike existing tests, however, the digital pregnancy test estimates the time since conception based on thresholds of hCG, which have been shown to rise rapidly after ovulation has occurred, and measurement of this hormone in the urine reflects the duration of pregnancy (Curr. Med. Res. Opin. 2009;25:741-8).

In using the digital home pregnancy test, the woman can either hold the test strip in the urine stream for 5 seconds or dip it into a urine sample collected in a clean container for 20 seconds. Results from the test are then given in a few minutes as a digital readout saying if the woman is "pregnant" or "not pregnant," with additional numbers displayed if conception was likely to be 1-2, 2-3, or 3+ weeks ago.

During the study, women were required to provide urine samples every day throughout their menstrual cycles, a random sample of which were then tested in the laboratory using the digital home pregnancy test.

A total of 250 women became pregnant during the study, with sufficient data on 153 women available for analysis. All of these women had ultrasound performed at approximately 11-13 weeks of their pregnancy to determine the gestational age according to the crown rump length measurement. More than 3,600 digital pregnancy tests were preformed in three batches, with the technicians blinded to the samples.

One of the interesting observations of the study is the inaccuracy of the LMP, Dr. Johnson said. All the women in the study planned on becoming pregnant and were carefully monitoring their menstrual cycles. Although they thought they knew exactly when their LMP was, the urine assessments suggested they were wrong by about 5 days.

"When a woman thinks she is pregnant, all she has is her last menstrual period, and that in so many cases is wrong, so this new test provides something that can provide greater accuracy," Dr. Johnson suggested.

SPD Development also has a digital ovulation test that is soon to be released in both the United States and the United Kingdom.

"Normal ovulation tests just measure luteinizing hormone [LH], so they tell you the best 2 days [to conceive]," Dr. Johnson said. The digital ovulation test still measures the LH surge, which indicates ovulation has occurred, but it also measures levels of estrone-3-glucuronide (E3G), which is a major urinary metabolite of estradiol. Levels of E3G rise a couple of days before the LH surge.

"By measuring [E3G], you are actually telling a woman about those additional fertile days during which she can also get pregnant before the 2 peak days," Dr. Johnson explained. Data presented in a poster at the annual meeting of ESHRE showed that the new digital ovulation test identified 4 or more fertile days in 80% of menstrual cycles.

The digital ovulation test will come as a kit with replaceable test strips. A woman urinates on the test strip, puts it into the reader, and the device then remembers the result and helps the woman identify her most fertile period.

The study was funded by SPD Development. Dr. Johnson is an employee of the company, which manufactures the Clearblue Digital Pregnancy Test With Conception Indicator and the Clearblue Digital Ovulation Test With Dual Hormone Indicator.

*Correction, 7/18/2013: An earlier version of this story misstated the availability of the test.

LONDON – Endometrial ovarian cysts do not reduce the rate of spontaneous ovulation and the potential ability of women to conceive, according to a prospective observational study.

Dr. Umberto Leone Roberti Maggiore of San Martino Hospital and the University of Genoa (Italy) reported the results of a study comparing the healthy and affected ovaries of 214 women with endometriosis. The overall rate of spontaneous ovulation was similar for affected and healthy ovaries over the course of six ovulatory cycles, at 50.3% vs. 49.7% (P = .919).

A total of 1,311 ovulatory cycles were examined during the study, with similar rates of ovulation observed regardless of the side, number, or size of endometriomas, he reported at the annual meeting of the European Society of Human Reproduction and Embryology.

Sara Freeman/IMNG Medical Media

"Over the last years, great attention has been given to the impact of endometriomas on ovarian physiology," Dr. Maggiore said. "Different studies have investigated whether the presence of endometriomas affect ovarian reserve and the outcome of assisted reproductive technologies."

Data from one study in particular suggested that the presence of endometriomas reduced the rate of spontaneous ovulation (Hum. Reprod. 2009;24:2183-6).

"The objective of the current study was to investigate the rate of spontaneous ovulation between the healthy and the affected ovary in women with unilateral endometriomas," Dr. Maggiore explained. Women were recruited into the study at an academic referral center between September 2009 and June 2013. For inclusion, they had to have ultrasound-confirmed endometrioma(s) of a single ovary of 20 mm or more in size, regular menstrual cycles (24-35 days), and a desire to conceive a child.

Women were excluded if they had previous adnexal surgery, had used hormonal therapies in the past 3 months, were pregnant or had breastfed their infants in the past 6 months, had a history of infertility, or had diagnoses of any of the following: hydrosalpinx, pelvic inflammatory disease, polycystic ovary syndrome, thyroid disorders, or psychiatric disturbances.

Transvaginal ultrasound was used to assess the side, number, largest diameter, and volume of the endometriomas. Ovarian reserve was assessed by measuring levels of anti-Müllerian hormone and basal follicle-stimulating hormone. The level of CA-125 was also measured.

The mean age of recruited women was 34 years; 55% of women had endometriomas of the right ovary, the majority (81.1%) had only one endometrial cyst, with 15.2% having two and 3.7% having three endometriomas. The largest diameter of the endometriomas at baseline was a mean of 4.5 cm, with 55.5% of women having a cyst equal to or greater than 4 cm and 15.1% a cyst equal to or greater than 6 cm. The total volume of endometriomas in the same ovary at baseline was a mean of 54.9 cm².

In terms of pregnancy outcomes, 43% of women conceived during the study period. Of these 63.8% were at term, 20% of patients had an ongoing pregnancy, 3.8% had been delivered preterm, 1.9% voluntarily terminated their pregnancy at the second trimester, and 10.5% had miscarriages.

No correlation was found between levels of follicle-stimulating hormone, anti-Müllerian hormone, or CA-125 and the total endometrial volume, the largest diameter of the endometrioma, or the number of endometriomas. However, the size and volume of the endometriomas by the sixth ovarian cycle were seen to increase from baseline values by a respective 3.9% and 8.1% (both P values less than .001).

Dr. Maggiore reported that 40.2% of women had a 0.1%-5% increase in the total volume of endometriomas over the course of the study, with 29.1% experiencing a volume increase of 5.1%-10%, a further 19.7% a volume increase of 10.1%-25%, and 4.7% an increase of 25.1% or more. Only 6.3% of women experienced a decrease in total endometrioma volume.

"Normal ovulatory function and the potential decrease of ovarian reserve should be considered before suggesting the surgical treatment of endometriomas," said Dr. Maggiore. While surgical removal of these cysts might not be necessary purely to improve fertility, it is too early to say if they will change practice.

"I think [the study] shows that the mere presence of endometrioma is not sufficient to operate," Dr. Thomas D’Hooghe of the Leuven (Belgium) University fertility center said in an interview.

However, Dr. D’Hooghe, who was not involved in the study, noted that an increase in endometrioma volume within 6 months of observation was not an insignificant finding. "If you extrapolate that to say 1 year or 2 years after baseline, there may be a larger increase in volume. ... The endometrioma may rupture and cause adhesions" at that point, he said.

"The fact that endometriomas appear to be progressive might suggest that women who want to conceive should perhaps undergo cystectomy as early as possible," Dr. D’Hooghe suggested. "I would think that if the endometrioma increases in size, sooner or later it may affect fertility."

Dr. Maggiore and Dr. D’Hooghe said they had no relevant financial disclosures.

LONDON – Endometrial ovarian cysts do not reduce the rate of spontaneous ovulation and the potential ability of women to conceive, according to a prospective observational study.

Dr. Umberto Leone Roberti Maggiore of San Martino Hospital and the University of Genoa (Italy) reported the results of a study comparing the healthy and affected ovaries of 214 women with endometriosis. The overall rate of spontaneous ovulation was similar for affected and healthy ovaries over the course of six ovulatory cycles, at 50.3% vs. 49.7% (P = .919).

A total of 1,311 ovulatory cycles were examined during the study, with similar rates of ovulation observed regardless of the side, number, or size of endometriomas, he reported at the annual meeting of the European Society of Human Reproduction and Embryology.

Sara Freeman/IMNG Medical Media

"Over the last years, great attention has been given to the impact of endometriomas on ovarian physiology," Dr. Maggiore said. "Different studies have investigated whether the presence of endometriomas affect ovarian reserve and the outcome of assisted reproductive technologies."

Data from one study in particular suggested that the presence of endometriomas reduced the rate of spontaneous ovulation (Hum. Reprod. 2009;24:2183-6).

"The objective of the current study was to investigate the rate of spontaneous ovulation between the healthy and the affected ovary in women with unilateral endometriomas," Dr. Maggiore explained. Women were recruited into the study at an academic referral center between September 2009 and June 2013. For inclusion, they had to have ultrasound-confirmed endometrioma(s) of a single ovary of 20 mm or more in size, regular menstrual cycles (24-35 days), and a desire to conceive a child.

Women were excluded if they had previous adnexal surgery, had used hormonal therapies in the past 3 months, were pregnant or had breastfed their infants in the past 6 months, had a history of infertility, or had diagnoses of any of the following: hydrosalpinx, pelvic inflammatory disease, polycystic ovary syndrome, thyroid disorders, or psychiatric disturbances.

Transvaginal ultrasound was used to assess the side, number, largest diameter, and volume of the endometriomas. Ovarian reserve was assessed by measuring levels of anti-Müllerian hormone and basal follicle-stimulating hormone. The level of CA-125 was also measured.

The mean age of recruited women was 34 years; 55% of women had endometriomas of the right ovary, the majority (81.1%) had only one endometrial cyst, with 15.2% having two and 3.7% having three endometriomas. The largest diameter of the endometriomas at baseline was a mean of 4.5 cm, with 55.5% of women having a cyst equal to or greater than 4 cm and 15.1% a cyst equal to or greater than 6 cm. The total volume of endometriomas in the same ovary at baseline was a mean of 54.9 cm².

In terms of pregnancy outcomes, 43% of women conceived during the study period. Of these 63.8% were at term, 20% of patients had an ongoing pregnancy, 3.8% had been delivered preterm, 1.9% voluntarily terminated their pregnancy at the second trimester, and 10.5% had miscarriages.

No correlation was found between levels of follicle-stimulating hormone, anti-Müllerian hormone, or CA-125 and the total endometrial volume, the largest diameter of the endometrioma, or the number of endometriomas. However, the size and volume of the endometriomas by the sixth ovarian cycle were seen to increase from baseline values by a respective 3.9% and 8.1% (both P values less than .001).

Dr. Maggiore reported that 40.2% of women had a 0.1%-5% increase in the total volume of endometriomas over the course of the study, with 29.1% experiencing a volume increase of 5.1%-10%, a further 19.7% a volume increase of 10.1%-25%, and 4.7% an increase of 25.1% or more. Only 6.3% of women experienced a decrease in total endometrioma volume.

"Normal ovulatory function and the potential decrease of ovarian reserve should be considered before suggesting the surgical treatment of endometriomas," said Dr. Maggiore. While surgical removal of these cysts might not be necessary purely to improve fertility, it is too early to say if they will change practice.

"I think [the study] shows that the mere presence of endometrioma is not sufficient to operate," Dr. Thomas D’Hooghe of the Leuven (Belgium) University fertility center said in an interview.

However, Dr. D’Hooghe, who was not involved in the study, noted that an increase in endometrioma volume within 6 months of observation was not an insignificant finding. "If you extrapolate that to say 1 year or 2 years after baseline, there may be a larger increase in volume. ... The endometrioma may rupture and cause adhesions" at that point, he said.

"The fact that endometriomas appear to be progressive might suggest that women who want to conceive should perhaps undergo cystectomy as early as possible," Dr. D’Hooghe suggested. "I would think that if the endometrioma increases in size, sooner or later it may affect fertility."

Dr. Maggiore and Dr. D’Hooghe said they had no relevant financial disclosures.

LONDON – Endometrial ovarian cysts do not reduce the rate of spontaneous ovulation and the potential ability of women to conceive, according to a prospective observational study.

Dr. Umberto Leone Roberti Maggiore of San Martino Hospital and the University of Genoa (Italy) reported the results of a study comparing the healthy and affected ovaries of 214 women with endometriosis. The overall rate of spontaneous ovulation was similar for affected and healthy ovaries over the course of six ovulatory cycles, at 50.3% vs. 49.7% (P = .919).

A total of 1,311 ovulatory cycles were examined during the study, with similar rates of ovulation observed regardless of the side, number, or size of endometriomas, he reported at the annual meeting of the European Society of Human Reproduction and Embryology.

Sara Freeman/IMNG Medical Media

"Over the last years, great attention has been given to the impact of endometriomas on ovarian physiology," Dr. Maggiore said. "Different studies have investigated whether the presence of endometriomas affect ovarian reserve and the outcome of assisted reproductive technologies."

Data from one study in particular suggested that the presence of endometriomas reduced the rate of spontaneous ovulation (Hum. Reprod. 2009;24:2183-6).

"The objective of the current study was to investigate the rate of spontaneous ovulation between the healthy and the affected ovary in women with unilateral endometriomas," Dr. Maggiore explained. Women were recruited into the study at an academic referral center between September 2009 and June 2013. For inclusion, they had to have ultrasound-confirmed endometrioma(s) of a single ovary of 20 mm or more in size, regular menstrual cycles (24-35 days), and a desire to conceive a child.

Women were excluded if they had previous adnexal surgery, had used hormonal therapies in the past 3 months, were pregnant or had breastfed their infants in the past 6 months, had a history of infertility, or had diagnoses of any of the following: hydrosalpinx, pelvic inflammatory disease, polycystic ovary syndrome, thyroid disorders, or psychiatric disturbances.

Transvaginal ultrasound was used to assess the side, number, largest diameter, and volume of the endometriomas. Ovarian reserve was assessed by measuring levels of anti-Müllerian hormone and basal follicle-stimulating hormone. The level of CA-125 was also measured.

The mean age of recruited women was 34 years; 55% of women had endometriomas of the right ovary, the majority (81.1%) had only one endometrial cyst, with 15.2% having two and 3.7% having three endometriomas. The largest diameter of the endometriomas at baseline was a mean of 4.5 cm, with 55.5% of women having a cyst equal to or greater than 4 cm and 15.1% a cyst equal to or greater than 6 cm. The total volume of endometriomas in the same ovary at baseline was a mean of 54.9 cm².

In terms of pregnancy outcomes, 43% of women conceived during the study period. Of these 63.8% were at term, 20% of patients had an ongoing pregnancy, 3.8% had been delivered preterm, 1.9% voluntarily terminated their pregnancy at the second trimester, and 10.5% had miscarriages.

No correlation was found between levels of follicle-stimulating hormone, anti-Müllerian hormone, or CA-125 and the total endometrial volume, the largest diameter of the endometrioma, or the number of endometriomas. However, the size and volume of the endometriomas by the sixth ovarian cycle were seen to increase from baseline values by a respective 3.9% and 8.1% (both P values less than .001).

Dr. Maggiore reported that 40.2% of women had a 0.1%-5% increase in the total volume of endometriomas over the course of the study, with 29.1% experiencing a volume increase of 5.1%-10%, a further 19.7% a volume increase of 10.1%-25%, and 4.7% an increase of 25.1% or more. Only 6.3% of women experienced a decrease in total endometrioma volume.

"Normal ovulatory function and the potential decrease of ovarian reserve should be considered before suggesting the surgical treatment of endometriomas," said Dr. Maggiore. While surgical removal of these cysts might not be necessary purely to improve fertility, it is too early to say if they will change practice.

"I think [the study] shows that the mere presence of endometrioma is not sufficient to operate," Dr. Thomas D’Hooghe of the Leuven (Belgium) University fertility center said in an interview.

However, Dr. D’Hooghe, who was not involved in the study, noted that an increase in endometrioma volume within 6 months of observation was not an insignificant finding. "If you extrapolate that to say 1 year or 2 years after baseline, there may be a larger increase in volume. ... The endometrioma may rupture and cause adhesions" at that point, he said.

"The fact that endometriomas appear to be progressive might suggest that women who want to conceive should perhaps undergo cystectomy as early as possible," Dr. D’Hooghe suggested. "I would think that if the endometrioma increases in size, sooner or later it may affect fertility."

Dr. Maggiore and Dr. D’Hooghe said they had no relevant financial disclosures.

LONDON – Intravenous thrombolysis administered within 6 hours of a stroke resulted in a significantly greater percentage of patients with better functional outcomes and quality of life after 18 months than did standard stroke care in an analysis of secondary endpoints in the Third International Stroke Trial.

At 18 months’ follow-up, a significant overall difference in quality of life on the EuroQoL-5 Dimensions (EQ-5D) instrument was seen in favor of tissue plasminogen activator (TPA) rather than placebo treatment (P = .03).

Furthermore, four out of the five domains measured by the EQ-5D were significantly improved, including mobility (P = .02), self-care (P = .001), usual activities (P = .008), and pain or discomfort (P = .03). The results of the Third International Stroke Trial (IST-3) at 18 months’ follow-up were recently published (Lancet Neurol. 2013;12:768-76).

Sara Freeman/IMNG Medical Media

"If you survive a stroke, you have to live with it for rather a very long time," said IST-3 chief investigator Dr. Peter Sandercock, who presented these secondary endpoint findings at the annual European Stroke Conference.

"I think this is something that many trials today have forgotten," said Dr. Sandercock, who is professor of medical neurology in the Centre for Clinical Brain Sciences at the University of Edinburgh (Scotland) and director of Edinburgh Neuroscience there. He added that treatments that produce relatively modest improvements in pathological outcomes in the short term might turn out to be cost effective in the long term.

Indeed, few trials in stroke to date have considered the longer-term quality-of-life effects of stroke treatment. The INTERACT2 trial (N. Engl. J. Med. 2013;368:2355-65) recently reported positive findings for blood pressure reduction in intracerebral hemorrhage, Dr. Sandercock noted, but IST-3 is the largest, and first, to report on the long-term benefits of thrombolysis in a stroke population. IST-3 is a randomized, controlled, open-treatment trial of 3,035 patients enrolled at 156 hospitals in 12 countries who were treated with intravenous thrombolysis or placebo within 6 hours of a stroke.

The primary endpoint results of IST-3 were published last year (Lancet 2012;379:2352-63) and showed a similar percentage of patients treated with TPA (37%) or placebo (35%) were "alive and independent" at 6 months, as signified by a score of 0-2 on the Oxford Handicap Scale (OHS). The OHS is similar to the modified Rankin Scale, with lower scores indicating no or minimal functional problems.

Now with longer follow-up out to 18 months, however, a higher percentage of TPA-treated patients had an OHS score of 0-2 (35% vs. 31% for the control group; odds ratio, 1.28; P = .024).

This result equates to an absolute difference of 36 more patients per 1,000 being alive and independent at 18 months if they received thrombolysis, Dr. Sandercock said. At 6 months, the absolute difference was not significant, with 14 more patients per 1,000 being independent if they received thrombolysis.

An ordinal shift analysis of OHS scores at 18 months showed that there was a similar percentage of deaths, at 37% for both treatment arms, but that all other scores were shifted in favor of TPA treatment (OR, 1.3; P = .002).

Of the 3,035 patients who participated in IST-3, 2,348 from 10 recruiting countries were eligible for inclusion in the 18-month follow-on study. Of these, 1,169 were treated with intravenous TPA, and the remainder were given a placebo injection.

Follow-up was by postal questionnaires, 44% of which were completed by a patient and 56% by a caregiver. If there was no response, a telephone-based interview was conducted. The investigators assessed QoL by the EQ-5D, EQ index, and EQ visual analog scale, as well as by an assessment of where the patient was living.

There was a marginal difference in patients’ living situations in favor of TPA treatment, with the agent being administered to 85.1% of patients living at home rather than in an institution versus 83.9% of patients given placebo (P = .05).

Boehringer Ingelheim donated the thrombolytic agent alteplase (Actilyse) to the first 300 patients but had no other role in the study. Dr. Sandercock disclosed that he has served as a speaker for Boehringer Ingelheim.

LONDON – Intravenous thrombolysis administered within 6 hours of a stroke resulted in a significantly greater percentage of patients with better functional outcomes and quality of life after 18 months than did standard stroke care in an analysis of secondary endpoints in the Third International Stroke Trial.

At 18 months’ follow-up, a significant overall difference in quality of life on the EuroQoL-5 Dimensions (EQ-5D) instrument was seen in favor of tissue plasminogen activator (TPA) rather than placebo treatment (P = .03).

Furthermore, four out of the five domains measured by the EQ-5D were significantly improved, including mobility (P = .02), self-care (P = .001), usual activities (P = .008), and pain or discomfort (P = .03). The results of the Third International Stroke Trial (IST-3) at 18 months’ follow-up were recently published (Lancet Neurol. 2013;12:768-76).

Sara Freeman/IMNG Medical Media

"If you survive a stroke, you have to live with it for rather a very long time," said IST-3 chief investigator Dr. Peter Sandercock, who presented these secondary endpoint findings at the annual European Stroke Conference.

"I think this is something that many trials today have forgotten," said Dr. Sandercock, who is professor of medical neurology in the Centre for Clinical Brain Sciences at the University of Edinburgh (Scotland) and director of Edinburgh Neuroscience there. He added that treatments that produce relatively modest improvements in pathological outcomes in the short term might turn out to be cost effective in the long term.

Indeed, few trials in stroke to date have considered the longer-term quality-of-life effects of stroke treatment. The INTERACT2 trial (N. Engl. J. Med. 2013;368:2355-65) recently reported positive findings for blood pressure reduction in intracerebral hemorrhage, Dr. Sandercock noted, but IST-3 is the largest, and first, to report on the long-term benefits of thrombolysis in a stroke population. IST-3 is a randomized, controlled, open-treatment trial of 3,035 patients enrolled at 156 hospitals in 12 countries who were treated with intravenous thrombolysis or placebo within 6 hours of a stroke.

The primary endpoint results of IST-3 were published last year (Lancet 2012;379:2352-63) and showed a similar percentage of patients treated with TPA (37%) or placebo (35%) were "alive and independent" at 6 months, as signified by a score of 0-2 on the Oxford Handicap Scale (OHS). The OHS is similar to the modified Rankin Scale, with lower scores indicating no or minimal functional problems.

Now with longer follow-up out to 18 months, however, a higher percentage of TPA-treated patients had an OHS score of 0-2 (35% vs. 31% for the control group; odds ratio, 1.28; P = .024).

This result equates to an absolute difference of 36 more patients per 1,000 being alive and independent at 18 months if they received thrombolysis, Dr. Sandercock said. At 6 months, the absolute difference was not significant, with 14 more patients per 1,000 being independent if they received thrombolysis.

An ordinal shift analysis of OHS scores at 18 months showed that there was a similar percentage of deaths, at 37% for both treatment arms, but that all other scores were shifted in favor of TPA treatment (OR, 1.3; P = .002).

Of the 3,035 patients who participated in IST-3, 2,348 from 10 recruiting countries were eligible for inclusion in the 18-month follow-on study. Of these, 1,169 were treated with intravenous TPA, and the remainder were given a placebo injection.

Follow-up was by postal questionnaires, 44% of which were completed by a patient and 56% by a caregiver. If there was no response, a telephone-based interview was conducted. The investigators assessed QoL by the EQ-5D, EQ index, and EQ visual analog scale, as well as by an assessment of where the patient was living.

There was a marginal difference in patients’ living situations in favor of TPA treatment, with the agent being administered to 85.1% of patients living at home rather than in an institution versus 83.9% of patients given placebo (P = .05).

Boehringer Ingelheim donated the thrombolytic agent alteplase (Actilyse) to the first 300 patients but had no other role in the study. Dr. Sandercock disclosed that he has served as a speaker for Boehringer Ingelheim.

LONDON – Intravenous thrombolysis administered within 6 hours of a stroke resulted in a significantly greater percentage of patients with better functional outcomes and quality of life after 18 months than did standard stroke care in an analysis of secondary endpoints in the Third International Stroke Trial.

At 18 months’ follow-up, a significant overall difference in quality of life on the EuroQoL-5 Dimensions (EQ-5D) instrument was seen in favor of tissue plasminogen activator (TPA) rather than placebo treatment (P = .03).

Furthermore, four out of the five domains measured by the EQ-5D were significantly improved, including mobility (P = .02), self-care (P = .001), usual activities (P = .008), and pain or discomfort (P = .03). The results of the Third International Stroke Trial (IST-3) at 18 months’ follow-up were recently published (Lancet Neurol. 2013;12:768-76).

Sara Freeman/IMNG Medical Media

"If you survive a stroke, you have to live with it for rather a very long time," said IST-3 chief investigator Dr. Peter Sandercock, who presented these secondary endpoint findings at the annual European Stroke Conference.

"I think this is something that many trials today have forgotten," said Dr. Sandercock, who is professor of medical neurology in the Centre for Clinical Brain Sciences at the University of Edinburgh (Scotland) and director of Edinburgh Neuroscience there. He added that treatments that produce relatively modest improvements in pathological outcomes in the short term might turn out to be cost effective in the long term.

Indeed, few trials in stroke to date have considered the longer-term quality-of-life effects of stroke treatment. The INTERACT2 trial (N. Engl. J. Med. 2013;368:2355-65) recently reported positive findings for blood pressure reduction in intracerebral hemorrhage, Dr. Sandercock noted, but IST-3 is the largest, and first, to report on the long-term benefits of thrombolysis in a stroke population. IST-3 is a randomized, controlled, open-treatment trial of 3,035 patients enrolled at 156 hospitals in 12 countries who were treated with intravenous thrombolysis or placebo within 6 hours of a stroke.

The primary endpoint results of IST-3 were published last year (Lancet 2012;379:2352-63) and showed a similar percentage of patients treated with TPA (37%) or placebo (35%) were "alive and independent" at 6 months, as signified by a score of 0-2 on the Oxford Handicap Scale (OHS). The OHS is similar to the modified Rankin Scale, with lower scores indicating no or minimal functional problems.

Now with longer follow-up out to 18 months, however, a higher percentage of TPA-treated patients had an OHS score of 0-2 (35% vs. 31% for the control group; odds ratio, 1.28; P = .024).

This result equates to an absolute difference of 36 more patients per 1,000 being alive and independent at 18 months if they received thrombolysis, Dr. Sandercock said. At 6 months, the absolute difference was not significant, with 14 more patients per 1,000 being independent if they received thrombolysis.

An ordinal shift analysis of OHS scores at 18 months showed that there was a similar percentage of deaths, at 37% for both treatment arms, but that all other scores were shifted in favor of TPA treatment (OR, 1.3; P = .002).

Of the 3,035 patients who participated in IST-3, 2,348 from 10 recruiting countries were eligible for inclusion in the 18-month follow-on study. Of these, 1,169 were treated with intravenous TPA, and the remainder were given a placebo injection.

Follow-up was by postal questionnaires, 44% of which were completed by a patient and 56% by a caregiver. If there was no response, a telephone-based interview was conducted. The investigators assessed QoL by the EQ-5D, EQ index, and EQ visual analog scale, as well as by an assessment of where the patient was living.

There was a marginal difference in patients’ living situations in favor of TPA treatment, with the agent being administered to 85.1% of patients living at home rather than in an institution versus 83.9% of patients given placebo (P = .05).

Boehringer Ingelheim donated the thrombolytic agent alteplase (Actilyse) to the first 300 patients but had no other role in the study. Dr. Sandercock disclosed that he has served as a speaker for Boehringer Ingelheim.

LONDON – People with aphasia and low mood after a stroke can benefit from behavioral therapy, the results of a multicenter, randomized controlled trial suggested.

In the Communication and Low Mood (CALM) study, patients who were in the behavioral therapy group reported better mood, as measured by the 21-item hospital version of the Stroke Aphasic Depression Questionnaire (SADQ) at both 3 and 6 months’ follow-up. Mean SADQ scores in the behavioral therapy versus the usual care arm were 16.9 and 19.2 at 3 months (P less than .05) and 17.4 and 21.9 at 6 months (P = .002), with a lower score indicating a better level of mood.

Depression is estimated to affect up to a third of patients after a stroke and can have detrimental effects on patients’ rehabilitation. It can cause psychological distress for patients and caregivers and is linked to higher mortality.

"People with aphasia may be particularly susceptible to depression, but they are often excluded from research," Dr. Shirley Thomas said at the annual European Stroke Conference.

Dr. Thomas of the Institute of Work, Health, and Organisations at the University of Nottingham (England) noted that few studies have looked at the use of psychological interventions for depression after a stroke. The studies that have been conducted have typically excluded people with aphasia because the interventions are often talk based and require good communication skills.

"Behavioral therapy is quite a practical and concrete approach that doesn’t require intact communication skills," Dr. Thomas said. She explained that it "is based on a behavior model of depression, the idea being that people develop depression because they are not getting positive reward and reinforcement from their environment." This "fits" with having aphasia following a stroke, she commented.

The aim of the CALM study, therefore, was to compare usual care alone with usual care plus the addition of a behavioral intervention to address low mood in patients with aphasia.

A total of 511 patients who had aphasia after a stroke were screened for signs of depression, with 105 identified as having "low mood" and consenting to participate in the trial. The mean age of the enrolled patients was 67 years and 63% were men. The trial began a median of 9 months after a stroke.

The behavioral therapy involved one-on-one sessions between a patient and a psychologist in the patient’s home, with up to 20 sessions occurring over a period of 3 months. Each session lasted for 1 hour and included patient education, which involved asking patients how they spent their time, identifying mood-lifting activities, scheduling these activities into each week, helping patients break down large tasks into graded steps, and giving people tasks to complete before the next session. Therapy was tailored to patients’ needs and guided by a manual specifically designed for the trial, which outlined all the various methods that could be used.

Two main instruments were used to assess patients’ mood in the trial: the SADQ and the ‘sad’ item of the Visual Analog Mood Scales (VAMS). Other measures used included the Visual Analog Self-Esteem Scale (VASES) and the Nottingham Leisure Questionnaire (NLQ).

When the VAMS was used, behavioral therapy was associated with significantly better mood at 3 months (P = .033) but not at 6 months. VASES scores were higher at 3 months in the behavioral therapy group than in those who got usual care, indicating better self-esteem, although results did not remain significant at 6 months. The results from the NLQ showed no significant differences between the groups.

A similar percentage of patients in the behavioral therapy and usual care groups took antidepressants (29% and 26%), so the differences that were seen in favor of behavioral therapy are not influenced by the use of these drugs, Dr. Thomas said.

"Overall, we found that the behavioral approaches [used] were appropriate and could be used in patients with aphasia," Dr. Thomas said. "This is important because this is a group of patients that are usually excluded from psychological interventions for mood problems," she added.

"Behavioral therapy appears to be promising, but going forward we need to look in more detail at the duration and content of treatment," Dr. Thomas said. It was unclear when the trial started how many sessions might be needed – no patient actually needed 20 sessions and most received about 10. An intervention period longer than 3 months might be better to integrate behavioral therapy into clinical practice and to ensure the effects are sustained, Dr. Thomas noted, but this needs to be confirmed by additional, larger trials with more statistical power.

The CALM study findings have been published (Clin. Rehabil. 2013;27:398-408). The Stroke Association in London funded the study. Dr. Thomas said she had no relevant financial disclosures.

LONDON – People with aphasia and low mood after a stroke can benefit from behavioral therapy, the results of a multicenter, randomized controlled trial suggested.

In the Communication and Low Mood (CALM) study, patients who were in the behavioral therapy group reported better mood, as measured by the 21-item hospital version of the Stroke Aphasic Depression Questionnaire (SADQ) at both 3 and 6 months’ follow-up. Mean SADQ scores in the behavioral therapy versus the usual care arm were 16.9 and 19.2 at 3 months (P less than .05) and 17.4 and 21.9 at 6 months (P = .002), with a lower score indicating a better level of mood.

Depression is estimated to affect up to a third of patients after a stroke and can have detrimental effects on patients’ rehabilitation. It can cause psychological distress for patients and caregivers and is linked to higher mortality.

"People with aphasia may be particularly susceptible to depression, but they are often excluded from research," Dr. Shirley Thomas said at the annual European Stroke Conference.

Dr. Thomas of the Institute of Work, Health, and Organisations at the University of Nottingham (England) noted that few studies have looked at the use of psychological interventions for depression after a stroke. The studies that have been conducted have typically excluded people with aphasia because the interventions are often talk based and require good communication skills.

"Behavioral therapy is quite a practical and concrete approach that doesn’t require intact communication skills," Dr. Thomas said. She explained that it "is based on a behavior model of depression, the idea being that people develop depression because they are not getting positive reward and reinforcement from their environment." This "fits" with having aphasia following a stroke, she commented.

The aim of the CALM study, therefore, was to compare usual care alone with usual care plus the addition of a behavioral intervention to address low mood in patients with aphasia.

A total of 511 patients who had aphasia after a stroke were screened for signs of depression, with 105 identified as having "low mood" and consenting to participate in the trial. The mean age of the enrolled patients was 67 years and 63% were men. The trial began a median of 9 months after a stroke.

The behavioral therapy involved one-on-one sessions between a patient and a psychologist in the patient’s home, with up to 20 sessions occurring over a period of 3 months. Each session lasted for 1 hour and included patient education, which involved asking patients how they spent their time, identifying mood-lifting activities, scheduling these activities into each week, helping patients break down large tasks into graded steps, and giving people tasks to complete before the next session. Therapy was tailored to patients’ needs and guided by a manual specifically designed for the trial, which outlined all the various methods that could be used.

Two main instruments were used to assess patients’ mood in the trial: the SADQ and the ‘sad’ item of the Visual Analog Mood Scales (VAMS). Other measures used included the Visual Analog Self-Esteem Scale (VASES) and the Nottingham Leisure Questionnaire (NLQ).

When the VAMS was used, behavioral therapy was associated with significantly better mood at 3 months (P = .033) but not at 6 months. VASES scores were higher at 3 months in the behavioral therapy group than in those who got usual care, indicating better self-esteem, although results did not remain significant at 6 months. The results from the NLQ showed no significant differences between the groups.

A similar percentage of patients in the behavioral therapy and usual care groups took antidepressants (29% and 26%), so the differences that were seen in favor of behavioral therapy are not influenced by the use of these drugs, Dr. Thomas said.

"Overall, we found that the behavioral approaches [used] were appropriate and could be used in patients with aphasia," Dr. Thomas said. "This is important because this is a group of patients that are usually excluded from psychological interventions for mood problems," she added.

"Behavioral therapy appears to be promising, but going forward we need to look in more detail at the duration and content of treatment," Dr. Thomas said. It was unclear when the trial started how many sessions might be needed – no patient actually needed 20 sessions and most received about 10. An intervention period longer than 3 months might be better to integrate behavioral therapy into clinical practice and to ensure the effects are sustained, Dr. Thomas noted, but this needs to be confirmed by additional, larger trials with more statistical power.

The CALM study findings have been published (Clin. Rehabil. 2013;27:398-408). The Stroke Association in London funded the study. Dr. Thomas said she had no relevant financial disclosures.

LONDON – People with aphasia and low mood after a stroke can benefit from behavioral therapy, the results of a multicenter, randomized controlled trial suggested.

In the Communication and Low Mood (CALM) study, patients who were in the behavioral therapy group reported better mood, as measured by the 21-item hospital version of the Stroke Aphasic Depression Questionnaire (SADQ) at both 3 and 6 months’ follow-up. Mean SADQ scores in the behavioral therapy versus the usual care arm were 16.9 and 19.2 at 3 months (P less than .05) and 17.4 and 21.9 at 6 months (P = .002), with a lower score indicating a better level of mood.

Depression is estimated to affect up to a third of patients after a stroke and can have detrimental effects on patients’ rehabilitation. It can cause psychological distress for patients and caregivers and is linked to higher mortality.

"People with aphasia may be particularly susceptible to depression, but they are often excluded from research," Dr. Shirley Thomas said at the annual European Stroke Conference.

Dr. Thomas of the Institute of Work, Health, and Organisations at the University of Nottingham (England) noted that few studies have looked at the use of psychological interventions for depression after a stroke. The studies that have been conducted have typically excluded people with aphasia because the interventions are often talk based and require good communication skills.

"Behavioral therapy is quite a practical and concrete approach that doesn’t require intact communication skills," Dr. Thomas said. She explained that it "is based on a behavior model of depression, the idea being that people develop depression because they are not getting positive reward and reinforcement from their environment." This "fits" with having aphasia following a stroke, she commented.

The aim of the CALM study, therefore, was to compare usual care alone with usual care plus the addition of a behavioral intervention to address low mood in patients with aphasia.

A total of 511 patients who had aphasia after a stroke were screened for signs of depression, with 105 identified as having "low mood" and consenting to participate in the trial. The mean age of the enrolled patients was 67 years and 63% were men. The trial began a median of 9 months after a stroke.

The behavioral therapy involved one-on-one sessions between a patient and a psychologist in the patient’s home, with up to 20 sessions occurring over a period of 3 months. Each session lasted for 1 hour and included patient education, which involved asking patients how they spent their time, identifying mood-lifting activities, scheduling these activities into each week, helping patients break down large tasks into graded steps, and giving people tasks to complete before the next session. Therapy was tailored to patients’ needs and guided by a manual specifically designed for the trial, which outlined all the various methods that could be used.

Two main instruments were used to assess patients’ mood in the trial: the SADQ and the ‘sad’ item of the Visual Analog Mood Scales (VAMS). Other measures used included the Visual Analog Self-Esteem Scale (VASES) and the Nottingham Leisure Questionnaire (NLQ).

When the VAMS was used, behavioral therapy was associated with significantly better mood at 3 months (P = .033) but not at 6 months. VASES scores were higher at 3 months in the behavioral therapy group than in those who got usual care, indicating better self-esteem, although results did not remain significant at 6 months. The results from the NLQ showed no significant differences between the groups.

A similar percentage of patients in the behavioral therapy and usual care groups took antidepressants (29% and 26%), so the differences that were seen in favor of behavioral therapy are not influenced by the use of these drugs, Dr. Thomas said.

"Overall, we found that the behavioral approaches [used] were appropriate and could be used in patients with aphasia," Dr. Thomas said. "This is important because this is a group of patients that are usually excluded from psychological interventions for mood problems," she added.

"Behavioral therapy appears to be promising, but going forward we need to look in more detail at the duration and content of treatment," Dr. Thomas said. It was unclear when the trial started how many sessions might be needed – no patient actually needed 20 sessions and most received about 10. An intervention period longer than 3 months might be better to integrate behavioral therapy into clinical practice and to ensure the effects are sustained, Dr. Thomas noted, but this needs to be confirmed by additional, larger trials with more statistical power.

The CALM study findings have been published (Clin. Rehabil. 2013;27:398-408). The Stroke Association in London funded the study. Dr. Thomas said she had no relevant financial disclosures.

MADRID – There is no added benefit of performing spinal MRI in the diagnosis of spondyloarthritis, the results of an international, multicenter study suggest.

Around one-quarter of patients with nonradiographic axial spondyloarthritis (nr-axSpA) who had a negative MRI scan of the sacroiliac joints (SIJs) were reclassified as being positive for SpA by a combined evaluation of SIJ MRI and spinal MRI scans.

However, 17.5% of healthy volunteers and up to 26.8% of patients with mechanical back pain who had a negative SIJ MRI were also reclassified as having SpA. This false-positive result balances out the value of combined spinal and SIJ MRI.

"Combined MRI added little incremental value compared to SIJ MRI alone for diagnosis of nr-axSpA," said Dr. Ulrich Weber, who presented the findings at the annual European Congress of Rheumatology (Ann. Rheum. Dis. 2013;72:145).

"Although you get about 20% more patients – which is the good news – we found about the same magnitude of false-positive controls," he said in an interview. He added that he "was very disappointed with this result, and these data need confirming." Dr. Weber collected data for the study while at the Balgrist University Clinic in Zurich, and also as a visiting professor in the rheumatology department at the University of Alberta, Edmonton.

SIJ MRI is a major criterion of the Assessment of SpondyloArthritis classification criteria for ankylosing spondylitis (AS). If a patient is strongly suspected of having early SpA, but this is not yet visible on radiographs, then an SIJ MRI is often the next step. If this is negative, however, it may be unclear what to do next.

"Our question was, ‘Would it help to order an additional spinal MRI in this situation?’ " Dr. Weber explained. These data suggest that it is not.

The collaborative study included 130 individuals with newly diagnosed back pain and aged 50 years or younger who were recruited from clinics based in Canada, China, Denmark, and Switzerland, as well as 20 healthy control individuals in whom MRI scans of the SIJ and spine were available.

The investigators used a clinical examination and pelvic radiography to stratify patients into groups, with 50 found to have nr-axSpA, 33 with AS, and 47 with mechanical back pain.

Three separate researchers blinded to the initial stratification read the MRI of the SIJ. An MRI of the spine was then performed 6 months later, with a combined SIJ/spinal scan done 1-12 months later. The presence or absence of SpA was determined in these scans, and comparisons were made between the results for MRI of the SIJ alone versus spinal MRI alone, as well as for the SIJ alone versus a combined read of both the spinal and SIJ MRI scans.

Dr. Weber noted that he would not recommend changing current practice as a result of this study. Further data are eagerly awaited from an ongoing Danish initiative that hopes to scan and assess around 2,000 whole-body MRIs in patients with suspected spondyloarthropathy by the end of the year. "This study will be very informative and very important for us because this is a large sample size. Preliminary data on about 1,000 MRIs point in the same direction," he observed.

Other data from the study, which Dr. Weber presented separately at the meeting, looked at the frequency and possible reasons for false-positive results with spinal MRI in the control groups (Ann. Rheum. Dis. 2013;72:125).

"Patients with mechanical back pain and healthy volunteers may show spinal MRI lesions suggestive of spondyloarthritis, such as corner inflammatory lesions or corner fat lesions," he explained. "We found that about 30% of those controls were misclassified as having spondyloarthritis by evaluation of the spinal MRI alone, so without SIJ MRI," said Dr. Weber. Bone marrow edema and fat infiltration were the MRI lesions largely responsible for this misclassification.

Dr. Weber said that, at least in Switzerland, general practitioners were more likely to order a spinal MRI than an SIJ MRI to assess a young patient with nonspecific back pain. "We think that caution is needed if a classification of SpA is based on MRI of the spine alone," he concluded.

Dr. Weber had no disclosures.

MADRID – There is no added benefit of performing spinal MRI in the diagnosis of spondyloarthritis, the results of an international, multicenter study suggest.

Around one-quarter of patients with nonradiographic axial spondyloarthritis (nr-axSpA) who had a negative MRI scan of the sacroiliac joints (SIJs) were reclassified as being positive for SpA by a combined evaluation of SIJ MRI and spinal MRI scans.

However, 17.5% of healthy volunteers and up to 26.8% of patients with mechanical back pain who had a negative SIJ MRI were also reclassified as having SpA. This false-positive result balances out the value of combined spinal and SIJ MRI.

"Combined MRI added little incremental value compared to SIJ MRI alone for diagnosis of nr-axSpA," said Dr. Ulrich Weber, who presented the findings at the annual European Congress of Rheumatology (Ann. Rheum. Dis. 2013;72:145).

"Although you get about 20% more patients – which is the good news – we found about the same magnitude of false-positive controls," he said in an interview. He added that he "was very disappointed with this result, and these data need confirming." Dr. Weber collected data for the study while at the Balgrist University Clinic in Zurich, and also as a visiting professor in the rheumatology department at the University of Alberta, Edmonton.

SIJ MRI is a major criterion of the Assessment of SpondyloArthritis classification criteria for ankylosing spondylitis (AS). If a patient is strongly suspected of having early SpA, but this is not yet visible on radiographs, then an SIJ MRI is often the next step. If this is negative, however, it may be unclear what to do next.

"Our question was, ‘Would it help to order an additional spinal MRI in this situation?’ " Dr. Weber explained. These data suggest that it is not.

The collaborative study included 130 individuals with newly diagnosed back pain and aged 50 years or younger who were recruited from clinics based in Canada, China, Denmark, and Switzerland, as well as 20 healthy control individuals in whom MRI scans of the SIJ and spine were available.

The investigators used a clinical examination and pelvic radiography to stratify patients into groups, with 50 found to have nr-axSpA, 33 with AS, and 47 with mechanical back pain.

Three separate researchers blinded to the initial stratification read the MRI of the SIJ. An MRI of the spine was then performed 6 months later, with a combined SIJ/spinal scan done 1-12 months later. The presence or absence of SpA was determined in these scans, and comparisons were made between the results for MRI of the SIJ alone versus spinal MRI alone, as well as for the SIJ alone versus a combined read of both the spinal and SIJ MRI scans.

Dr. Weber noted that he would not recommend changing current practice as a result of this study. Further data are eagerly awaited from an ongoing Danish initiative that hopes to scan and assess around 2,000 whole-body MRIs in patients with suspected spondyloarthropathy by the end of the year. "This study will be very informative and very important for us because this is a large sample size. Preliminary data on about 1,000 MRIs point in the same direction," he observed.

Other data from the study, which Dr. Weber presented separately at the meeting, looked at the frequency and possible reasons for false-positive results with spinal MRI in the control groups (Ann. Rheum. Dis. 2013;72:125).

"Patients with mechanical back pain and healthy volunteers may show spinal MRI lesions suggestive of spondyloarthritis, such as corner inflammatory lesions or corner fat lesions," he explained. "We found that about 30% of those controls were misclassified as having spondyloarthritis by evaluation of the spinal MRI alone, so without SIJ MRI," said Dr. Weber. Bone marrow edema and fat infiltration were the MRI lesions largely responsible for this misclassification.

Dr. Weber said that, at least in Switzerland, general practitioners were more likely to order a spinal MRI than an SIJ MRI to assess a young patient with nonspecific back pain. "We think that caution is needed if a classification of SpA is based on MRI of the spine alone," he concluded.

Dr. Weber had no disclosures.

MADRID – There is no added benefit of performing spinal MRI in the diagnosis of spondyloarthritis, the results of an international, multicenter study suggest.

Around one-quarter of patients with nonradiographic axial spondyloarthritis (nr-axSpA) who had a negative MRI scan of the sacroiliac joints (SIJs) were reclassified as being positive for SpA by a combined evaluation of SIJ MRI and spinal MRI scans.

However, 17.5% of healthy volunteers and up to 26.8% of patients with mechanical back pain who had a negative SIJ MRI were also reclassified as having SpA. This false-positive result balances out the value of combined spinal and SIJ MRI.

"Combined MRI added little incremental value compared to SIJ MRI alone for diagnosis of nr-axSpA," said Dr. Ulrich Weber, who presented the findings at the annual European Congress of Rheumatology (Ann. Rheum. Dis. 2013;72:145).

"Although you get about 20% more patients – which is the good news – we found about the same magnitude of false-positive controls," he said in an interview. He added that he "was very disappointed with this result, and these data need confirming." Dr. Weber collected data for the study while at the Balgrist University Clinic in Zurich, and also as a visiting professor in the rheumatology department at the University of Alberta, Edmonton.

SIJ MRI is a major criterion of the Assessment of SpondyloArthritis classification criteria for ankylosing spondylitis (AS). If a patient is strongly suspected of having early SpA, but this is not yet visible on radiographs, then an SIJ MRI is often the next step. If this is negative, however, it may be unclear what to do next.

"Our question was, ‘Would it help to order an additional spinal MRI in this situation?’ " Dr. Weber explained. These data suggest that it is not.

The collaborative study included 130 individuals with newly diagnosed back pain and aged 50 years or younger who were recruited from clinics based in Canada, China, Denmark, and Switzerland, as well as 20 healthy control individuals in whom MRI scans of the SIJ and spine were available.

The investigators used a clinical examination and pelvic radiography to stratify patients into groups, with 50 found to have nr-axSpA, 33 with AS, and 47 with mechanical back pain.

Three separate researchers blinded to the initial stratification read the MRI of the SIJ. An MRI of the spine was then performed 6 months later, with a combined SIJ/spinal scan done 1-12 months later. The presence or absence of SpA was determined in these scans, and comparisons were made between the results for MRI of the SIJ alone versus spinal MRI alone, as well as for the SIJ alone versus a combined read of both the spinal and SIJ MRI scans.

Dr. Weber noted that he would not recommend changing current practice as a result of this study. Further data are eagerly awaited from an ongoing Danish initiative that hopes to scan and assess around 2,000 whole-body MRIs in patients with suspected spondyloarthropathy by the end of the year. "This study will be very informative and very important for us because this is a large sample size. Preliminary data on about 1,000 MRIs point in the same direction," he observed.

Other data from the study, which Dr. Weber presented separately at the meeting, looked at the frequency and possible reasons for false-positive results with spinal MRI in the control groups (Ann. Rheum. Dis. 2013;72:125).

"Patients with mechanical back pain and healthy volunteers may show spinal MRI lesions suggestive of spondyloarthritis, such as corner inflammatory lesions or corner fat lesions," he explained. "We found that about 30% of those controls were misclassified as having spondyloarthritis by evaluation of the spinal MRI alone, so without SIJ MRI," said Dr. Weber. Bone marrow edema and fat infiltration were the MRI lesions largely responsible for this misclassification.

Dr. Weber said that, at least in Switzerland, general practitioners were more likely to order a spinal MRI than an SIJ MRI to assess a young patient with nonspecific back pain. "We think that caution is needed if a classification of SpA is based on MRI of the spine alone," he concluded.

Dr. Weber had no disclosures.

MADRID – An international team has developed a new composite health index specifically for use in patients with ankylosing spondylitis.

The Assessment of SpondyloArthritis International Society Health Index (ASAS HI) is based on the ICF (International Classification of Functioning, Disability and Health) and includes 17 dichotomous items that ask about patients’ levels of pain, emotional functioning, sleep habits, sexual function, mobility, self-care, life in the community, and employment. The ICF is a comprehensive and already well-recognized and validated means of classifying and describing functioning, disability, and health in a systematic way,

The tool has yet to be "field tested" to see if it can measure changes in health status in response to treatment, Dr. Uta Kiltz said at the annual European Congress of Rheumatology.

Dr. Kiltz, of Rheumazentrum Ruhrgebiet, Herne, Germany, noted that the development of the tool involved five key stages. These have been outlined previously (Rheumatology 2011;50:894-8) and included a preparatory stage in which potential items for inclusion were identified. Dr. Kiltz and her colleagues considered a total of 251 items obtained from more than 60 existing questionnaires, such as the BASFI (Bath Ankylosing Spondylitis Functional Index), the Dougados Functional Index, and the AS Quality of Life Questionnaire.

The investigators then conducted an international, cross-sectional study involving 1,915 patients with AS (mean age, 51 years). In this second phase, they sent a postal survey to patients to ask about various parameters. An expert committee then assessed the results in the third phase and selected 50 items for possible inclusion in the final model. The penultimate stage in the development process involved sending a second postal survey to 628 patients with AS (mean age, 48.5 years).

In the final stage, an expert consensus meeting was held in which the final 17-item tool was agreed upon (Ann. Rheum. Dis. 2013;72:124).

"ASAS HI is a new composite index that captures relevant information on the health status of patients with AS," Dr. Kiltz said. "It is the first disease-specific index which is based on the ICF, and the items represent a whole range of abilities as defined by the ICF."

ASAS HI could eventually be used in clinical trials and clinical practice as a new composite index that captures relevant information on the health status of patients, Dr. Kiltz suggested.

"We are now doing a field test to test the 17 items in a wider range of patients," she said. After this is completed, the specifics of the tool will be published.

Dr. Kiltz had no conflicts of interest.

MADRID – An international team has developed a new composite health index specifically for use in patients with ankylosing spondylitis.

The Assessment of SpondyloArthritis International Society Health Index (ASAS HI) is based on the ICF (International Classification of Functioning, Disability and Health) and includes 17 dichotomous items that ask about patients’ levels of pain, emotional functioning, sleep habits, sexual function, mobility, self-care, life in the community, and employment. The ICF is a comprehensive and already well-recognized and validated means of classifying and describing functioning, disability, and health in a systematic way,

The tool has yet to be "field tested" to see if it can measure changes in health status in response to treatment, Dr. Uta Kiltz said at the annual European Congress of Rheumatology.

Dr. Kiltz, of Rheumazentrum Ruhrgebiet, Herne, Germany, noted that the development of the tool involved five key stages. These have been outlined previously (Rheumatology 2011;50:894-8) and included a preparatory stage in which potential items for inclusion were identified. Dr. Kiltz and her colleagues considered a total of 251 items obtained from more than 60 existing questionnaires, such as the BASFI (Bath Ankylosing Spondylitis Functional Index), the Dougados Functional Index, and the AS Quality of Life Questionnaire.

The investigators then conducted an international, cross-sectional study involving 1,915 patients with AS (mean age, 51 years). In this second phase, they sent a postal survey to patients to ask about various parameters. An expert committee then assessed the results in the third phase and selected 50 items for possible inclusion in the final model. The penultimate stage in the development process involved sending a second postal survey to 628 patients with AS (mean age, 48.5 years).

In the final stage, an expert consensus meeting was held in which the final 17-item tool was agreed upon (Ann. Rheum. Dis. 2013;72:124).

"ASAS HI is a new composite index that captures relevant information on the health status of patients with AS," Dr. Kiltz said. "It is the first disease-specific index which is based on the ICF, and the items represent a whole range of abilities as defined by the ICF."

ASAS HI could eventually be used in clinical trials and clinical practice as a new composite index that captures relevant information on the health status of patients, Dr. Kiltz suggested.

"We are now doing a field test to test the 17 items in a wider range of patients," she said. After this is completed, the specifics of the tool will be published.

Dr. Kiltz had no conflicts of interest.

MADRID – An international team has developed a new composite health index specifically for use in patients with ankylosing spondylitis.

The Assessment of SpondyloArthritis International Society Health Index (ASAS HI) is based on the ICF (International Classification of Functioning, Disability and Health) and includes 17 dichotomous items that ask about patients’ levels of pain, emotional functioning, sleep habits, sexual function, mobility, self-care, life in the community, and employment. The ICF is a comprehensive and already well-recognized and validated means of classifying and describing functioning, disability, and health in a systematic way,

The tool has yet to be "field tested" to see if it can measure changes in health status in response to treatment, Dr. Uta Kiltz said at the annual European Congress of Rheumatology.

Dr. Kiltz, of Rheumazentrum Ruhrgebiet, Herne, Germany, noted that the development of the tool involved five key stages. These have been outlined previously (Rheumatology 2011;50:894-8) and included a preparatory stage in which potential items for inclusion were identified. Dr. Kiltz and her colleagues considered a total of 251 items obtained from more than 60 existing questionnaires, such as the BASFI (Bath Ankylosing Spondylitis Functional Index), the Dougados Functional Index, and the AS Quality of Life Questionnaire.

The investigators then conducted an international, cross-sectional study involving 1,915 patients with AS (mean age, 51 years). In this second phase, they sent a postal survey to patients to ask about various parameters. An expert committee then assessed the results in the third phase and selected 50 items for possible inclusion in the final model. The penultimate stage in the development process involved sending a second postal survey to 628 patients with AS (mean age, 48.5 years).

In the final stage, an expert consensus meeting was held in which the final 17-item tool was agreed upon (Ann. Rheum. Dis. 2013;72:124).

"ASAS HI is a new composite index that captures relevant information on the health status of patients with AS," Dr. Kiltz said. "It is the first disease-specific index which is based on the ICF, and the items represent a whole range of abilities as defined by the ICF."

ASAS HI could eventually be used in clinical trials and clinical practice as a new composite index that captures relevant information on the health status of patients, Dr. Kiltz suggested.

"We are now doing a field test to test the 17 items in a wider range of patients," she said. After this is completed, the specifics of the tool will be published.

Dr. Kiltz had no conflicts of interest.

MADRID – High baseline disease activity and serum C-reactive protein levels may be a means of predicting which patients with spondyloarthropathy are likely to develop cardiovascular disease.

Both were linked to arterial stiffness, a surrogate marker for heart disease, in a 5-year follow-up study of 103 hospital-recruited patients with ankylosing spondylitis (Ann. Rheum. Dis 2013;72[Suppls3]:125).

"Reducing disease activity may [therefore] be a viable way of reducing excess cardiovascular disease [CVD] in ankylosing spondylitis [AS]," study investigator Dr. Inger Jorid Berg said at the annual European Congress of Rheumatology.

Baseline disease severity was measured with the ankylosing spondylitis disease activity score (ASDAS) and the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI). However, only ASDAS predicted the development of increased arterial stiffness from high baseline disease activity.

"Several studies have shown that patients with ankylosing spondylitis have [an] increased [risk] of cardiovascular disease," noted Dr. Berg, a consultant rheumatologist at Diakonhjemmet Hospital in Oslo. This includes atherosclerotic CVD, she observed, which previous research has linked to having a high ASDAS.

The present investigation explored whether high baseline ASDAS could be used to predict increased arterial stiffness as measured with the Augmentation Index (AIx). The investigators measured arterial stiffness using the SphygmoCor apparatus, a noninvasive system that involves placement of a probe at the radial artery.

Patients included in the study had AS confirmed via modified New York criteria and had undergone assessments in 2003 and again in 2008-2009. The assessments included clinical examinations and questionnaires to assess baseline disease severity and blood tests to measure C-reactive protein (CRP) levels and the erythrocyte sedimentation rate (ESR).

At the baseline assessment in 2003, the patients (56% men) had a mean age of 48 years, and a mean body mass index of 24.4 kg/m². A quarter of the patients were smokers. Their mean ASDAS was 2.5 and their mean BASDAI was 4.1, indicating moderate disease activity. There were only a few known cardiovascular comorbidities present, which included hypertension (5%) and diabetes (3%), although there were more patients with comorbidities at the later assessment. Most (83%) patients were taking nonsteroidal antiinflammatory drugs. Another 17% were using disease-modifying antirheumatic drugs, and very few (2%) were using tumor necrosis factor inhibitors.

"There was a clear trend in increasing CRP values, ESR values, and ASDAS," Dr. Berg said. This was significant for CRP (P = .004) and ASDAS (P = .01), and borderline significant for ESR (P = .05).

Multivariate analysis showed that CRP and ASDAS were independent predictors of increasing AIx, with an odds ratio of 2.09 (P = .02) for the latter.

"The strengths of this study are its longitudinal design and a representative cohort reflecting a range of disease activity," Dr. Berg observed. "Limitations are the low number of patients and that there might be a selection bias when inviting patients to examinations." Traditional risk factors were also not recorded during the 2003 assessment, so the effect of these variables could not be evaluated.

What these data show, however, are that inflammation signaled by elevated CRP and high disease activity measured by ASDAS predict future arterial stiffness, indicating that both are risk factors of CVD in AS. As such, better control of both of these parameters might be a way to reduce risk for CVD in this patient population.

Dr. Berg did not have any conflicts of interest to disclose.

MADRID – High baseline disease activity and serum C-reactive protein levels may be a means of predicting which patients with spondyloarthropathy are likely to develop cardiovascular disease.

Both were linked to arterial stiffness, a surrogate marker for heart disease, in a 5-year follow-up study of 103 hospital-recruited patients with ankylosing spondylitis (Ann. Rheum. Dis 2013;72[Suppls3]:125).

"Reducing disease activity may [therefore] be a viable way of reducing excess cardiovascular disease [CVD] in ankylosing spondylitis [AS]," study investigator Dr. Inger Jorid Berg said at the annual European Congress of Rheumatology.

Baseline disease severity was measured with the ankylosing spondylitis disease activity score (ASDAS) and the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI). However, only ASDAS predicted the development of increased arterial stiffness from high baseline disease activity.

"Several studies have shown that patients with ankylosing spondylitis have [an] increased [risk] of cardiovascular disease," noted Dr. Berg, a consultant rheumatologist at Diakonhjemmet Hospital in Oslo. This includes atherosclerotic CVD, she observed, which previous research has linked to having a high ASDAS.

The present investigation explored whether high baseline ASDAS could be used to predict increased arterial stiffness as measured with the Augmentation Index (AIx). The investigators measured arterial stiffness using the SphygmoCor apparatus, a noninvasive system that involves placement of a probe at the radial artery.

Patients included in the study had AS confirmed via modified New York criteria and had undergone assessments in 2003 and again in 2008-2009. The assessments included clinical examinations and questionnaires to assess baseline disease severity and blood tests to measure C-reactive protein (CRP) levels and the erythrocyte sedimentation rate (ESR).

At the baseline assessment in 2003, the patients (56% men) had a mean age of 48 years, and a mean body mass index of 24.4 kg/m². A quarter of the patients were smokers. Their mean ASDAS was 2.5 and their mean BASDAI was 4.1, indicating moderate disease activity. There were only a few known cardiovascular comorbidities present, which included hypertension (5%) and diabetes (3%), although there were more patients with comorbidities at the later assessment. Most (83%) patients were taking nonsteroidal antiinflammatory drugs. Another 17% were using disease-modifying antirheumatic drugs, and very few (2%) were using tumor necrosis factor inhibitors.

"There was a clear trend in increasing CRP values, ESR values, and ASDAS," Dr. Berg said. This was significant for CRP (P = .004) and ASDAS (P = .01), and borderline significant for ESR (P = .05).

Multivariate analysis showed that CRP and ASDAS were independent predictors of increasing AIx, with an odds ratio of 2.09 (P = .02) for the latter.

"The strengths of this study are its longitudinal design and a representative cohort reflecting a range of disease activity," Dr. Berg observed. "Limitations are the low number of patients and that there might be a selection bias when inviting patients to examinations." Traditional risk factors were also not recorded during the 2003 assessment, so the effect of these variables could not be evaluated.

What these data show, however, are that inflammation signaled by elevated CRP and high disease activity measured by ASDAS predict future arterial stiffness, indicating that both are risk factors of CVD in AS. As such, better control of both of these parameters might be a way to reduce risk for CVD in this patient population.

Dr. Berg did not have any conflicts of interest to disclose.

MADRID – High baseline disease activity and serum C-reactive protein levels may be a means of predicting which patients with spondyloarthropathy are likely to develop cardiovascular disease.

Both were linked to arterial stiffness, a surrogate marker for heart disease, in a 5-year follow-up study of 103 hospital-recruited patients with ankylosing spondylitis (Ann. Rheum. Dis 2013;72[Suppls3]:125).

"Reducing disease activity may [therefore] be a viable way of reducing excess cardiovascular disease [CVD] in ankylosing spondylitis [AS]," study investigator Dr. Inger Jorid Berg said at the annual European Congress of Rheumatology.

Baseline disease severity was measured with the ankylosing spondylitis disease activity score (ASDAS) and the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI). However, only ASDAS predicted the development of increased arterial stiffness from high baseline disease activity.

"Several studies have shown that patients with ankylosing spondylitis have [an] increased [risk] of cardiovascular disease," noted Dr. Berg, a consultant rheumatologist at Diakonhjemmet Hospital in Oslo. This includes atherosclerotic CVD, she observed, which previous research has linked to having a high ASDAS.

The present investigation explored whether high baseline ASDAS could be used to predict increased arterial stiffness as measured with the Augmentation Index (AIx). The investigators measured arterial stiffness using the SphygmoCor apparatus, a noninvasive system that involves placement of a probe at the radial artery.

Patients included in the study had AS confirmed via modified New York criteria and had undergone assessments in 2003 and again in 2008-2009. The assessments included clinical examinations and questionnaires to assess baseline disease severity and blood tests to measure C-reactive protein (CRP) levels and the erythrocyte sedimentation rate (ESR).

At the baseline assessment in 2003, the patients (56% men) had a mean age of 48 years, and a mean body mass index of 24.4 kg/m². A quarter of the patients were smokers. Their mean ASDAS was 2.5 and their mean BASDAI was 4.1, indicating moderate disease activity. There were only a few known cardiovascular comorbidities present, which included hypertension (5%) and diabetes (3%), although there were more patients with comorbidities at the later assessment. Most (83%) patients were taking nonsteroidal antiinflammatory drugs. Another 17% were using disease-modifying antirheumatic drugs, and very few (2%) were using tumor necrosis factor inhibitors.

"There was a clear trend in increasing CRP values, ESR values, and ASDAS," Dr. Berg said. This was significant for CRP (P = .004) and ASDAS (P = .01), and borderline significant for ESR (P = .05).

Multivariate analysis showed that CRP and ASDAS were independent predictors of increasing AIx, with an odds ratio of 2.09 (P = .02) for the latter.

"The strengths of this study are its longitudinal design and a representative cohort reflecting a range of disease activity," Dr. Berg observed. "Limitations are the low number of patients and that there might be a selection bias when inviting patients to examinations." Traditional risk factors were also not recorded during the 2003 assessment, so the effect of these variables could not be evaluated.

What these data show, however, are that inflammation signaled by elevated CRP and high disease activity measured by ASDAS predict future arterial stiffness, indicating that both are risk factors of CVD in AS. As such, better control of both of these parameters might be a way to reduce risk for CVD in this patient population.

Dr. Berg did not have any conflicts of interest to disclose.

MADRID – A new radiographic scoring method successfully assessed damage in the large joints of patients with rheumatoid arthritis who were being treated with biologic therapy, according to research presented at the annual European Congress of Rheumatology.

The ARASHI (Assessment of Rheumatoid Arthritis by Scoring of Large-Joint Destruction and Healing in Radiographic Imaging) method, developed by a team in Japan, was tested over a period of 2 years in 51 patients who were being newly treated with tumor necrosis factor–alpha (TNF-alpha) inhibitors.

"Evaluation of radiographic damage of the small joints in the hands and feet using the van der Heijde total Sharp score in patients with early RA has been established," said Dr. Isao Matsushita, assistant professor in the orthopedic surgery department at the University of Toyama, Japan.

While the Larsen grade is most often used to assess large joints, this radiographic grading system has several limitations, including a "ceiling effect," resulting from the substantial variation found within each of the six Larsen grades (scored 0-5), he said in an interview at the meeting. Dr. Matsushita and his colleagues developed the ARASHI method to offer a more sensitive means of determining radiographic progression in the large joints.

The ARASHI method is composed of two parts (Mod. Rheumatol. 2013 April 27 [doi: 10.1007/s10165-012-0823-6]), Dr. Matsushita explained. First, there is a status score, which takes into account four categories: joint space narrowing (scored 0-3), erosion (scored 0-3), joint surface (0-6), and joint stability (0-4). Second, there is a change score, which assesses the same four categories plus the porosity of the joint.

A total of 57 patients with early RA who were about to be treated with TNF-alpha inhibitors were included in the study, and 51 completed 2 years’ treatment with these agents. The most frequently prescribed TNF-alpha inhibitors were infliximab, in 24 patients, and etanercept, used in 14. Another 7 patients switched from infliximab to etanercept, and 6 patients were treated with adalimumab. The mean age of the patients was 60 years, with a mean RA duration of 10.6 years.

The investigators used the ARASHI status score to assess 96 hip and 86 knee joints at baseline (before TNF-alpha inhibitor treatment was started). They later computed the ARASHI change score for the joints at both 1-year and 2-year follow-up visits. A 1-point or more increase in the ARASHI change score constituted radiographic progression. Higher scores indicated higher levels of joint damage.

All of the hip and knee joints with a status score of greater than 2 showed progression of joint damage under TNF-blocking therapies, Dr. Matsushita said. He added that of the joints with a low baseline ARASHI status score (0-2), only 6.5% showed progressive damage over the course of the study. Furthermore, the joint space narrowing score was more closely related to the joint damage subsequently seen than was the erosion score.

Taken together, these findings demonstrate that the "ARASHI scoring method is useful for the evaluation of radiographic damage in large weight-bearing joints, and to predict the risk for progression in patients with RA," Dr. Matsushita said. The next step is to look at the utility of the score in other large joints, perhaps the shoulder, elbow, and ankle joints, he noted.

Dr. Matsushita had no disclosures.

MADRID – A new radiographic scoring method successfully assessed damage in the large joints of patients with rheumatoid arthritis who were being treated with biologic therapy, according to research presented at the annual European Congress of Rheumatology.

The ARASHI (Assessment of Rheumatoid Arthritis by Scoring of Large-Joint Destruction and Healing in Radiographic Imaging) method, developed by a team in Japan, was tested over a period of 2 years in 51 patients who were being newly treated with tumor necrosis factor–alpha (TNF-alpha) inhibitors.

"Evaluation of radiographic damage of the small joints in the hands and feet using the van der Heijde total Sharp score in patients with early RA has been established," said Dr. Isao Matsushita, assistant professor in the orthopedic surgery department at the University of Toyama, Japan.

While the Larsen grade is most often used to assess large joints, this radiographic grading system has several limitations, including a "ceiling effect," resulting from the substantial variation found within each of the six Larsen grades (scored 0-5), he said in an interview at the meeting. Dr. Matsushita and his colleagues developed the ARASHI method to offer a more sensitive means of determining radiographic progression in the large joints.

The ARASHI method is composed of two parts (Mod. Rheumatol. 2013 April 27 [doi: 10.1007/s10165-012-0823-6]), Dr. Matsushita explained. First, there is a status score, which takes into account four categories: joint space narrowing (scored 0-3), erosion (scored 0-3), joint surface (0-6), and joint stability (0-4). Second, there is a change score, which assesses the same four categories plus the porosity of the joint.

A total of 57 patients with early RA who were about to be treated with TNF-alpha inhibitors were included in the study, and 51 completed 2 years’ treatment with these agents. The most frequently prescribed TNF-alpha inhibitors were infliximab, in 24 patients, and etanercept, used in 14. Another 7 patients switched from infliximab to etanercept, and 6 patients were treated with adalimumab. The mean age of the patients was 60 years, with a mean RA duration of 10.6 years.

The investigators used the ARASHI status score to assess 96 hip and 86 knee joints at baseline (before TNF-alpha inhibitor treatment was started). They later computed the ARASHI change score for the joints at both 1-year and 2-year follow-up visits. A 1-point or more increase in the ARASHI change score constituted radiographic progression. Higher scores indicated higher levels of joint damage.

All of the hip and knee joints with a status score of greater than 2 showed progression of joint damage under TNF-blocking therapies, Dr. Matsushita said. He added that of the joints with a low baseline ARASHI status score (0-2), only 6.5% showed progressive damage over the course of the study. Furthermore, the joint space narrowing score was more closely related to the joint damage subsequently seen than was the erosion score.

Taken together, these findings demonstrate that the "ARASHI scoring method is useful for the evaluation of radiographic damage in large weight-bearing joints, and to predict the risk for progression in patients with RA," Dr. Matsushita said. The next step is to look at the utility of the score in other large joints, perhaps the shoulder, elbow, and ankle joints, he noted.

Dr. Matsushita had no disclosures.

MADRID – A new radiographic scoring method successfully assessed damage in the large joints of patients with rheumatoid arthritis who were being treated with biologic therapy, according to research presented at the annual European Congress of Rheumatology.

The ARASHI (Assessment of Rheumatoid Arthritis by Scoring of Large-Joint Destruction and Healing in Radiographic Imaging) method, developed by a team in Japan, was tested over a period of 2 years in 51 patients who were being newly treated with tumor necrosis factor–alpha (TNF-alpha) inhibitors.

"Evaluation of radiographic damage of the small joints in the hands and feet using the van der Heijde total Sharp score in patients with early RA has been established," said Dr. Isao Matsushita, assistant professor in the orthopedic surgery department at the University of Toyama, Japan.

While the Larsen grade is most often used to assess large joints, this radiographic grading system has several limitations, including a "ceiling effect," resulting from the substantial variation found within each of the six Larsen grades (scored 0-5), he said in an interview at the meeting. Dr. Matsushita and his colleagues developed the ARASHI method to offer a more sensitive means of determining radiographic progression in the large joints.

The ARASHI method is composed of two parts (Mod. Rheumatol. 2013 April 27 [doi: 10.1007/s10165-012-0823-6]), Dr. Matsushita explained. First, there is a status score, which takes into account four categories: joint space narrowing (scored 0-3), erosion (scored 0-3), joint surface (0-6), and joint stability (0-4). Second, there is a change score, which assesses the same four categories plus the porosity of the joint.

A total of 57 patients with early RA who were about to be treated with TNF-alpha inhibitors were included in the study, and 51 completed 2 years’ treatment with these agents. The most frequently prescribed TNF-alpha inhibitors were infliximab, in 24 patients, and etanercept, used in 14. Another 7 patients switched from infliximab to etanercept, and 6 patients were treated with adalimumab. The mean age of the patients was 60 years, with a mean RA duration of 10.6 years.

The investigators used the ARASHI status score to assess 96 hip and 86 knee joints at baseline (before TNF-alpha inhibitor treatment was started). They later computed the ARASHI change score for the joints at both 1-year and 2-year follow-up visits. A 1-point or more increase in the ARASHI change score constituted radiographic progression. Higher scores indicated higher levels of joint damage.

All of the hip and knee joints with a status score of greater than 2 showed progression of joint damage under TNF-blocking therapies, Dr. Matsushita said. He added that of the joints with a low baseline ARASHI status score (0-2), only 6.5% showed progressive damage over the course of the study. Furthermore, the joint space narrowing score was more closely related to the joint damage subsequently seen than was the erosion score.

Taken together, these findings demonstrate that the "ARASHI scoring method is useful for the evaluation of radiographic damage in large weight-bearing joints, and to predict the risk for progression in patients with RA," Dr. Matsushita said. The next step is to look at the utility of the score in other large joints, perhaps the shoulder, elbow, and ankle joints, he noted.

Dr. Matsushita had no disclosures.

MADRID – Having a child was associated with ACPA-negative but not ACPA-positive rheumatoid arthritis in a case-control study of almost 5,000 women living in Sweden.

The odds ratio (OR) for ACPA (anti–citrullinated protein antibody)–negative rheumatoid arthritis (RA) comparing parous with nulliparous women was 2.1 in women aged 18-44 years. The effect was not seen in older women, with an OR of 0.9 for women aged 45-70 years.

"The risk seems to be more pronounced in the postpartum period [in the] 2 years before the onset of [RA] symptoms," Cecilia Orellana reported at the annual European Congress of Rheumatology. Indeed, the odds of developing ACPA-positive disease within the first year of childbirth (OR = 2.6) was higher than within 2 years (OR = 1.8).

Ms. Orellana, a second-year postgraduate student within the Institute of Environmental Medicine at the Karolinska Institutet in Stockholm, also noted that the risk of ACPA-negative RA appeared higher in women who had their first child at a young age. The OR for ACPA-negative RA in women younger than 23 years was 2.5, followed by 2.1 for those aged 23-26 years, 1.8 for those aged 27-30 years, and 1.5 for those older than 30 years.

The link between parity and RA has been studied before with some findings suggesting no association and others finding a possible protective effect of parity on the risk of RA. This is the only study to date to look at parity in relation to ACPA status (Ann. Rheum. Dis. 2013;72[Suppl. 3]:102).

The case-control study involved 2,035 women with RA and 2,911 age-matched controls enrolled in the ongoing Swedish EIRA (Epidemiological Investigation of RA) study during 1996-2009. Nearly two-thirds (64%) of women with RA were ACPA positive.

ORs were adjusted for smoking status, education, body mass index, age of menarche, and oral contraceptive use, but none of these adjustments altered the risk of developing RA.

The biological mechanisms behind the increased risk for ACPA-negative RA in women who have given birth needs further study, Ms. Orellana concluded.

The findings appear "counterintuitive" to what clinicians might assume, Dr. Christopher Buckley, professor of rheumatology at the University of Birmingham, England, said in an interview.

"I would have predicted that if women had had more children, there might have been more [ACPA-positive] disease, because you are more likely to have immune suppression, but this [study] actually suggests that women are protected from [ACPA-positive] disease," said Dr. Buckley, who was not involved in the study. "This might mean that pregnancy is not a bad thing," he said, adding that if women do get pregnant they are more likely to have ACPA-negative disease, which actually carries a better prognosis.

As for how these data could help clinicians advise women, Dr. Buckley noted that it is of course very likely that there is more than a single factor at play. Other factors would almost certainly be influencing the risk of RA. But these data beg the question as to how many children a woman might need to have to produce an effect. Since parity seems to influence ACPA-negative RA risk in younger women, the findings might be most relevant in the developing world where women tend to have their children at a younger age.

"It’s one of those results that is completely counterintuitive," Dr. Buckley said, "which usually tells you that there is something going on."

Ms. Orellana and Dr. Buckley had no disclosures. The study was supported by grants from the Swedish Medical Research Council, the Swedish Council for Working Life and Social Research, King Gustav V’s 80-year Foundation, the Swedish Rheumatic Foundation, the Stockholm County Council, and the insurance company AFA.

MADRID – Having a child was associated with ACPA-negative but not ACPA-positive rheumatoid arthritis in a case-control study of almost 5,000 women living in Sweden.

The odds ratio (OR) for ACPA (anti–citrullinated protein antibody)–negative rheumatoid arthritis (RA) comparing parous with nulliparous women was 2.1 in women aged 18-44 years. The effect was not seen in older women, with an OR of 0.9 for women aged 45-70 years.

"The risk seems to be more pronounced in the postpartum period [in the] 2 years before the onset of [RA] symptoms," Cecilia Orellana reported at the annual European Congress of Rheumatology. Indeed, the odds of developing ACPA-positive disease within the first year of childbirth (OR = 2.6) was higher than within 2 years (OR = 1.8).

Ms. Orellana, a second-year postgraduate student within the Institute of Environmental Medicine at the Karolinska Institutet in Stockholm, also noted that the risk of ACPA-negative RA appeared higher in women who had their first child at a young age. The OR for ACPA-negative RA in women younger than 23 years was 2.5, followed by 2.1 for those aged 23-26 years, 1.8 for those aged 27-30 years, and 1.5 for those older than 30 years.

The link between parity and RA has been studied before with some findings suggesting no association and others finding a possible protective effect of parity on the risk of RA. This is the only study to date to look at parity in relation to ACPA status (Ann. Rheum. Dis. 2013;72[Suppl. 3]:102).

The case-control study involved 2,035 women with RA and 2,911 age-matched controls enrolled in the ongoing Swedish EIRA (Epidemiological Investigation of RA) study during 1996-2009. Nearly two-thirds (64%) of women with RA were ACPA positive.

ORs were adjusted for smoking status, education, body mass index, age of menarche, and oral contraceptive use, but none of these adjustments altered the risk of developing RA.

The biological mechanisms behind the increased risk for ACPA-negative RA in women who have given birth needs further study, Ms. Orellana concluded.

The findings appear "counterintuitive" to what clinicians might assume, Dr. Christopher Buckley, professor of rheumatology at the University of Birmingham, England, said in an interview.

"I would have predicted that if women had had more children, there might have been more [ACPA-positive] disease, because you are more likely to have immune suppression, but this [study] actually suggests that women are protected from [ACPA-positive] disease," said Dr. Buckley, who was not involved in the study. "This might mean that pregnancy is not a bad thing," he said, adding that if women do get pregnant they are more likely to have ACPA-negative disease, which actually carries a better prognosis.

As for how these data could help clinicians advise women, Dr. Buckley noted that it is of course very likely that there is more than a single factor at play. Other factors would almost certainly be influencing the risk of RA. But these data beg the question as to how many children a woman might need to have to produce an effect. Since parity seems to influence ACPA-negative RA risk in younger women, the findings might be most relevant in the developing world where women tend to have their children at a younger age.

"It’s one of those results that is completely counterintuitive," Dr. Buckley said, "which usually tells you that there is something going on."

Ms. Orellana and Dr. Buckley had no disclosures. The study was supported by grants from the Swedish Medical Research Council, the Swedish Council for Working Life and Social Research, King Gustav V’s 80-year Foundation, the Swedish Rheumatic Foundation, the Stockholm County Council, and the insurance company AFA.

MADRID – Having a child was associated with ACPA-negative but not ACPA-positive rheumatoid arthritis in a case-control study of almost 5,000 women living in Sweden.

The odds ratio (OR) for ACPA (anti–citrullinated protein antibody)–negative rheumatoid arthritis (RA) comparing parous with nulliparous women was 2.1 in women aged 18-44 years. The effect was not seen in older women, with an OR of 0.9 for women aged 45-70 years.

"The risk seems to be more pronounced in the postpartum period [in the] 2 years before the onset of [RA] symptoms," Cecilia Orellana reported at the annual European Congress of Rheumatology. Indeed, the odds of developing ACPA-positive disease within the first year of childbirth (OR = 2.6) was higher than within 2 years (OR = 1.8).

Ms. Orellana, a second-year postgraduate student within the Institute of Environmental Medicine at the Karolinska Institutet in Stockholm, also noted that the risk of ACPA-negative RA appeared higher in women who had their first child at a young age. The OR for ACPA-negative RA in women younger than 23 years was 2.5, followed by 2.1 for those aged 23-26 years, 1.8 for those aged 27-30 years, and 1.5 for those older than 30 years.

The link between parity and RA has been studied before with some findings suggesting no association and others finding a possible protective effect of parity on the risk of RA. This is the only study to date to look at parity in relation to ACPA status (Ann. Rheum. Dis. 2013;72[Suppl. 3]:102).

The case-control study involved 2,035 women with RA and 2,911 age-matched controls enrolled in the ongoing Swedish EIRA (Epidemiological Investigation of RA) study during 1996-2009. Nearly two-thirds (64%) of women with RA were ACPA positive.

ORs were adjusted for smoking status, education, body mass index, age of menarche, and oral contraceptive use, but none of these adjustments altered the risk of developing RA.

The biological mechanisms behind the increased risk for ACPA-negative RA in women who have given birth needs further study, Ms. Orellana concluded.

The findings appear "counterintuitive" to what clinicians might assume, Dr. Christopher Buckley, professor of rheumatology at the University of Birmingham, England, said in an interview.

"I would have predicted that if women had had more children, there might have been more [ACPA-positive] disease, because you are more likely to have immune suppression, but this [study] actually suggests that women are protected from [ACPA-positive] disease," said Dr. Buckley, who was not involved in the study. "This might mean that pregnancy is not a bad thing," he said, adding that if women do get pregnant they are more likely to have ACPA-negative disease, which actually carries a better prognosis.

As for how these data could help clinicians advise women, Dr. Buckley noted that it is of course very likely that there is more than a single factor at play. Other factors would almost certainly be influencing the risk of RA. But these data beg the question as to how many children a woman might need to have to produce an effect. Since parity seems to influence ACPA-negative RA risk in younger women, the findings might be most relevant in the developing world where women tend to have their children at a younger age.

"It’s one of those results that is completely counterintuitive," Dr. Buckley said, "which usually tells you that there is something going on."

Ms. Orellana and Dr. Buckley had no disclosures. The study was supported by grants from the Swedish Medical Research Council, the Swedish Council for Working Life and Social Research, King Gustav V’s 80-year Foundation, the Swedish Rheumatic Foundation, the Stockholm County Council, and the insurance company AFA.