Spondyloarthropathies

Patients with psoriatic arthritis who began taking disease-modifying antirheumatic drugs often changed regimens soon afterward, especially if they had started with nonbiologic treatments, researchers reported online in Arthritis Research and Therapy.

Only 31% of patients who started methotrexate or another nonbiologic disease-modifying antirheumatic drug (DMARD) for psoriatic arthritis stayed with their initial treatment for the next year, compared with 54% of patients who started on a biologic DMARD such as etanercept, infliximab, or golimumab, said Dr. Huabin F. Zhang at Celgene in Summit, N.J., and his associates.

The researchers analyzed U. S. health care claims data for 1,698 adults with psoriatic arthritis who were started on oral nonbiologic DMARDs and for 3,263 patients started on biologic DMARDs. In all, 69% of patients who started nonbiologic DMARDs and 46% of those who started biologic DMARDs discontinued, switched, or added on to their treatment within a year of starting therapy, they found. Patients most often switched to or added a biologic as opposed to a nonbiologic DMARD, the investigators said. Those who started on nonbiologics primarily took methotrexate, and "patient persistence with treatment was generally low and relatively brief," they said. Other studies have shown that use of nonbiologic DMARDs "erodes rapidly and progressively over time," they said (Arthritis Res. Ther. 2014 Aug. 22 [doi:10.1186/s13075-014-0420-5]).

Health insurance companies often require patients to take one or two nonbiologics before they will reimburse for a biologic DMARD, which could partially explain these findings, the researchers said. But the retrospective observational study did not capture data on side effects, safety concerns, or other reasons for treatment changes, they noted.

Celgene funded the study and employs Dr. Zhang. The other three coauthors reported receiving consultancy fees from Celgene.

Patients with psoriatic arthritis who began taking disease-modifying antirheumatic drugs often changed regimens soon afterward, especially if they had started with nonbiologic treatments, researchers reported online in Arthritis Research and Therapy.

Only 31% of patients who started methotrexate or another nonbiologic disease-modifying antirheumatic drug (DMARD) for psoriatic arthritis stayed with their initial treatment for the next year, compared with 54% of patients who started on a biologic DMARD such as etanercept, infliximab, or golimumab, said Dr. Huabin F. Zhang at Celgene in Summit, N.J., and his associates.

The researchers analyzed U. S. health care claims data for 1,698 adults with psoriatic arthritis who were started on oral nonbiologic DMARDs and for 3,263 patients started on biologic DMARDs. In all, 69% of patients who started nonbiologic DMARDs and 46% of those who started biologic DMARDs discontinued, switched, or added on to their treatment within a year of starting therapy, they found. Patients most often switched to or added a biologic as opposed to a nonbiologic DMARD, the investigators said. Those who started on nonbiologics primarily took methotrexate, and "patient persistence with treatment was generally low and relatively brief," they said. Other studies have shown that use of nonbiologic DMARDs "erodes rapidly and progressively over time," they said (Arthritis Res. Ther. 2014 Aug. 22 [doi:10.1186/s13075-014-0420-5]).

Health insurance companies often require patients to take one or two nonbiologics before they will reimburse for a biologic DMARD, which could partially explain these findings, the researchers said. But the retrospective observational study did not capture data on side effects, safety concerns, or other reasons for treatment changes, they noted.

Celgene funded the study and employs Dr. Zhang. The other three coauthors reported receiving consultancy fees from Celgene.

Patients with psoriatic arthritis who began taking disease-modifying antirheumatic drugs often changed regimens soon afterward, especially if they had started with nonbiologic treatments, researchers reported online in Arthritis Research and Therapy.

Only 31% of patients who started methotrexate or another nonbiologic disease-modifying antirheumatic drug (DMARD) for psoriatic arthritis stayed with their initial treatment for the next year, compared with 54% of patients who started on a biologic DMARD such as etanercept, infliximab, or golimumab, said Dr. Huabin F. Zhang at Celgene in Summit, N.J., and his associates.

The researchers analyzed U. S. health care claims data for 1,698 adults with psoriatic arthritis who were started on oral nonbiologic DMARDs and for 3,263 patients started on biologic DMARDs. In all, 69% of patients who started nonbiologic DMARDs and 46% of those who started biologic DMARDs discontinued, switched, or added on to their treatment within a year of starting therapy, they found. Patients most often switched to or added a biologic as opposed to a nonbiologic DMARD, the investigators said. Those who started on nonbiologics primarily took methotrexate, and "patient persistence with treatment was generally low and relatively brief," they said. Other studies have shown that use of nonbiologic DMARDs "erodes rapidly and progressively over time," they said (Arthritis Res. Ther. 2014 Aug. 22 [doi:10.1186/s13075-014-0420-5]).

Health insurance companies often require patients to take one or two nonbiologics before they will reimburse for a biologic DMARD, which could partially explain these findings, the researchers said. But the retrospective observational study did not capture data on side effects, safety concerns, or other reasons for treatment changes, they noted.

Celgene funded the study and employs Dr. Zhang. The other three coauthors reported receiving consultancy fees from Celgene.

VANCOUVER, B.C. – Results from some studies have concluded that treatment with conventional systemic or biologic therapy improves the elevated risk of cardiovascular disease in patients with psoriasis, but the association is not yet definitive, according to Dr. Robert Kalb.

"Current evidence is suggestive, but certainly our patients with psoriasis need intensive management of cardiovascular risk factors and appropriate psoriasis therapy, which may also produce benefits from a cardiovascular standpoint," Dr. Kalb said at the annual meeting of the Pacific Dermatologic Association.

Researchers who conducted the earliest study to explore the association between psoriasis and increased risk for cardiovascular death found that when they controlled for risk factors including age, sex, smoking, diabetes, hypertension, and hyperlipidemia, having psoriasis led to a hazard ratio of 1.57 for cardiovascular death (Eur. Heart J. 2010;31:1000-6). Since that time, six meta-analyses have appeared in the medical literature showing that psoriasis is linked to an increased risk of cardiovascular disease. Most of these studies defined severe psoriasis as patients who had received a systemic agent. Body surface area or other objective measures of psoriasis were not part of the definition, said Dr. Kalb, a dermatologist in group practice in Buffalo.

Emerging evidence supports the idea that increased risk factors are associated with the severity of psoriasis. As part of the landmark Incident Health Outcomes and Psoriasis Events (iHope) study, investigators found that patients with disease affecting 10% or more body surface area had an increased risk of myocardial infarction. One study defined psoriasis severity by body surface area (JAMA Dermatol. 2013;149:1173-9). The investigators found that the burdens of MI and other comorbid diseases increase with increasing disease severity, particularly in those with 10% body surface area or more affected.

Investigators are also working to determine if systemic therapy reduces the risk of MI in psoriasis patients. The Consortium of Rheumatology Researchers of North America (CORRONA) registry database found that in patients with rheumatoid arthritis, anti–tumor necrosis factor (TNF) agents reduced the risk of cardiovascular events (HR, 0.39), compared with nonbiologic disease-modifying antirheumatic drugs. Methotrexate did not reduce the risk of cardiovascular events, while the use of prednisone increased the risk (Ann. Rheum. Dis. 2011;70:576-82). Another review showed that anti-TNF therapy decreased the risk, but the use of methotrexate decreased the risk slightly more (Rheumatology 2011;50:518-31). "Reassuringly, there was no increased risk of congestive heart failure, which has always been [included] in the label of [anti-]TNF agents," Dr. Kalb said.

A cohort study of 25,554 patients with moderate to severe psoriasis used U.S. administrative and pharmacy claims data to examine the risk of acute myocardial infarction in those who underwent systemic therapy, compared with those who underwent phototherapy. The investigators found a trend toward an increased risk of MI in those who received systemic therapy, but there were no significant differences in risk between the two treatment groups (Br. J. Dermatol. 2011;165:1066-73). On the other hand, a retrospective, longitudinal cohort study of 2,400 patients with severe psoriasis in Denmark showed that the use of biologic agents and methotrexate was associated with fewer cardiovascular events (hazard ratios, 0.48 and 0.50, respectively), but the use of other antipsoriatic therapies – including cyclosporine, retinoids, phototherapy, and topicals – were not (J. Intern Med. 2013;273:197-204).

A retrospective cohort study of 8,845 Kaiser Permanente psoriasis patients set out to determine whether treatment with TNF inhibitors was associated with a decreased risk of MI, compared with those who did not receive TNF inhibitors (Arch. Dermatol. 2012;148:1244-50) . After adjusting for MI risk factors, the researchers found that those who received TNF inhibitors had a significantly lower risk of MI, compared with those who received topical therapy (adjusted HR, 0.50).

"Why do different studies reach different conclusions?" Dr. Kalb asked. "Different populations were studied, and there were differences in terms of how reference groups were defined and in the methods for categorizing therapy and severity of disease. Data from population studies are not yet sufficient to determine whether [anti-]TNF agents will reduce the incidence of MI."

One conundrum for researchers is how to measure this decreased risk. "What surrogate markers should we use?" Dr. Kalb asked. "One study showed a significant decrease in CRP [C-reactive protein] and ESR [erythrocyte sedimentation rate] in patients receiving therapy. The gold standard of decrease in mortality in this type of study will not be done because it requires thousands of patients studied over at least 10 years." However, in cardiology, 18-fluorodeoxyglucose PET scanning shows decreased inflammation in patients taking statins. Whether the same effect can be shown in psoriasis patients taking systemic medications for their disease remains unknown, but prospective studies are ongoing.

Dr. Kalb disclosed that he is an investigator and/or consultant for AbbVie, Amgen, Celgene, Dermira, Janssen, Leo, Merck, Pfizer, and Taro. He is also on the dermatology safety monitoring board for ApoPharma and Eli Lilly.

dbrunk@frontlinemedcom.com

On Twitter @dougbrunk

VANCOUVER, B.C. – Results from some studies have concluded that treatment with conventional systemic or biologic therapy improves the elevated risk of cardiovascular disease in patients with psoriasis, but the association is not yet definitive, according to Dr. Robert Kalb.

"Current evidence is suggestive, but certainly our patients with psoriasis need intensive management of cardiovascular risk factors and appropriate psoriasis therapy, which may also produce benefits from a cardiovascular standpoint," Dr. Kalb said at the annual meeting of the Pacific Dermatologic Association.

Researchers who conducted the earliest study to explore the association between psoriasis and increased risk for cardiovascular death found that when they controlled for risk factors including age, sex, smoking, diabetes, hypertension, and hyperlipidemia, having psoriasis led to a hazard ratio of 1.57 for cardiovascular death (Eur. Heart J. 2010;31:1000-6). Since that time, six meta-analyses have appeared in the medical literature showing that psoriasis is linked to an increased risk of cardiovascular disease. Most of these studies defined severe psoriasis as patients who had received a systemic agent. Body surface area or other objective measures of psoriasis were not part of the definition, said Dr. Kalb, a dermatologist in group practice in Buffalo.

Emerging evidence supports the idea that increased risk factors are associated with the severity of psoriasis. As part of the landmark Incident Health Outcomes and Psoriasis Events (iHope) study, investigators found that patients with disease affecting 10% or more body surface area had an increased risk of myocardial infarction. One study defined psoriasis severity by body surface area (JAMA Dermatol. 2013;149:1173-9). The investigators found that the burdens of MI and other comorbid diseases increase with increasing disease severity, particularly in those with 10% body surface area or more affected.

Investigators are also working to determine if systemic therapy reduces the risk of MI in psoriasis patients. The Consortium of Rheumatology Researchers of North America (CORRONA) registry database found that in patients with rheumatoid arthritis, anti–tumor necrosis factor (TNF) agents reduced the risk of cardiovascular events (HR, 0.39), compared with nonbiologic disease-modifying antirheumatic drugs. Methotrexate did not reduce the risk of cardiovascular events, while the use of prednisone increased the risk (Ann. Rheum. Dis. 2011;70:576-82). Another review showed that anti-TNF therapy decreased the risk, but the use of methotrexate decreased the risk slightly more (Rheumatology 2011;50:518-31). "Reassuringly, there was no increased risk of congestive heart failure, which has always been [included] in the label of [anti-]TNF agents," Dr. Kalb said.

A cohort study of 25,554 patients with moderate to severe psoriasis used U.S. administrative and pharmacy claims data to examine the risk of acute myocardial infarction in those who underwent systemic therapy, compared with those who underwent phototherapy. The investigators found a trend toward an increased risk of MI in those who received systemic therapy, but there were no significant differences in risk between the two treatment groups (Br. J. Dermatol. 2011;165:1066-73). On the other hand, a retrospective, longitudinal cohort study of 2,400 patients with severe psoriasis in Denmark showed that the use of biologic agents and methotrexate was associated with fewer cardiovascular events (hazard ratios, 0.48 and 0.50, respectively), but the use of other antipsoriatic therapies – including cyclosporine, retinoids, phototherapy, and topicals – were not (J. Intern Med. 2013;273:197-204).

A retrospective cohort study of 8,845 Kaiser Permanente psoriasis patients set out to determine whether treatment with TNF inhibitors was associated with a decreased risk of MI, compared with those who did not receive TNF inhibitors (Arch. Dermatol. 2012;148:1244-50) . After adjusting for MI risk factors, the researchers found that those who received TNF inhibitors had a significantly lower risk of MI, compared with those who received topical therapy (adjusted HR, 0.50).

"Why do different studies reach different conclusions?" Dr. Kalb asked. "Different populations were studied, and there were differences in terms of how reference groups were defined and in the methods for categorizing therapy and severity of disease. Data from population studies are not yet sufficient to determine whether [anti-]TNF agents will reduce the incidence of MI."

One conundrum for researchers is how to measure this decreased risk. "What surrogate markers should we use?" Dr. Kalb asked. "One study showed a significant decrease in CRP [C-reactive protein] and ESR [erythrocyte sedimentation rate] in patients receiving therapy. The gold standard of decrease in mortality in this type of study will not be done because it requires thousands of patients studied over at least 10 years." However, in cardiology, 18-fluorodeoxyglucose PET scanning shows decreased inflammation in patients taking statins. Whether the same effect can be shown in psoriasis patients taking systemic medications for their disease remains unknown, but prospective studies are ongoing.

Dr. Kalb disclosed that he is an investigator and/or consultant for AbbVie, Amgen, Celgene, Dermira, Janssen, Leo, Merck, Pfizer, and Taro. He is also on the dermatology safety monitoring board for ApoPharma and Eli Lilly.

dbrunk@frontlinemedcom.com

On Twitter @dougbrunk

VANCOUVER, B.C. – Results from some studies have concluded that treatment with conventional systemic or biologic therapy improves the elevated risk of cardiovascular disease in patients with psoriasis, but the association is not yet definitive, according to Dr. Robert Kalb.

"Current evidence is suggestive, but certainly our patients with psoriasis need intensive management of cardiovascular risk factors and appropriate psoriasis therapy, which may also produce benefits from a cardiovascular standpoint," Dr. Kalb said at the annual meeting of the Pacific Dermatologic Association.

Researchers who conducted the earliest study to explore the association between psoriasis and increased risk for cardiovascular death found that when they controlled for risk factors including age, sex, smoking, diabetes, hypertension, and hyperlipidemia, having psoriasis led to a hazard ratio of 1.57 for cardiovascular death (Eur. Heart J. 2010;31:1000-6). Since that time, six meta-analyses have appeared in the medical literature showing that psoriasis is linked to an increased risk of cardiovascular disease. Most of these studies defined severe psoriasis as patients who had received a systemic agent. Body surface area or other objective measures of psoriasis were not part of the definition, said Dr. Kalb, a dermatologist in group practice in Buffalo.

Emerging evidence supports the idea that increased risk factors are associated with the severity of psoriasis. As part of the landmark Incident Health Outcomes and Psoriasis Events (iHope) study, investigators found that patients with disease affecting 10% or more body surface area had an increased risk of myocardial infarction. One study defined psoriasis severity by body surface area (JAMA Dermatol. 2013;149:1173-9). The investigators found that the burdens of MI and other comorbid diseases increase with increasing disease severity, particularly in those with 10% body surface area or more affected.

Investigators are also working to determine if systemic therapy reduces the risk of MI in psoriasis patients. The Consortium of Rheumatology Researchers of North America (CORRONA) registry database found that in patients with rheumatoid arthritis, anti–tumor necrosis factor (TNF) agents reduced the risk of cardiovascular events (HR, 0.39), compared with nonbiologic disease-modifying antirheumatic drugs. Methotrexate did not reduce the risk of cardiovascular events, while the use of prednisone increased the risk (Ann. Rheum. Dis. 2011;70:576-82). Another review showed that anti-TNF therapy decreased the risk, but the use of methotrexate decreased the risk slightly more (Rheumatology 2011;50:518-31). "Reassuringly, there was no increased risk of congestive heart failure, which has always been [included] in the label of [anti-]TNF agents," Dr. Kalb said.

A cohort study of 25,554 patients with moderate to severe psoriasis used U.S. administrative and pharmacy claims data to examine the risk of acute myocardial infarction in those who underwent systemic therapy, compared with those who underwent phototherapy. The investigators found a trend toward an increased risk of MI in those who received systemic therapy, but there were no significant differences in risk between the two treatment groups (Br. J. Dermatol. 2011;165:1066-73). On the other hand, a retrospective, longitudinal cohort study of 2,400 patients with severe psoriasis in Denmark showed that the use of biologic agents and methotrexate was associated with fewer cardiovascular events (hazard ratios, 0.48 and 0.50, respectively), but the use of other antipsoriatic therapies – including cyclosporine, retinoids, phototherapy, and topicals – were not (J. Intern Med. 2013;273:197-204).

A retrospective cohort study of 8,845 Kaiser Permanente psoriasis patients set out to determine whether treatment with TNF inhibitors was associated with a decreased risk of MI, compared with those who did not receive TNF inhibitors (Arch. Dermatol. 2012;148:1244-50) . After adjusting for MI risk factors, the researchers found that those who received TNF inhibitors had a significantly lower risk of MI, compared with those who received topical therapy (adjusted HR, 0.50).

"Why do different studies reach different conclusions?" Dr. Kalb asked. "Different populations were studied, and there were differences in terms of how reference groups were defined and in the methods for categorizing therapy and severity of disease. Data from population studies are not yet sufficient to determine whether [anti-]TNF agents will reduce the incidence of MI."

One conundrum for researchers is how to measure this decreased risk. "What surrogate markers should we use?" Dr. Kalb asked. "One study showed a significant decrease in CRP [C-reactive protein] and ESR [erythrocyte sedimentation rate] in patients receiving therapy. The gold standard of decrease in mortality in this type of study will not be done because it requires thousands of patients studied over at least 10 years." However, in cardiology, 18-fluorodeoxyglucose PET scanning shows decreased inflammation in patients taking statins. Whether the same effect can be shown in psoriasis patients taking systemic medications for their disease remains unknown, but prospective studies are ongoing.

Dr. Kalb disclosed that he is an investigator and/or consultant for AbbVie, Amgen, Celgene, Dermira, Janssen, Leo, Merck, Pfizer, and Taro. He is also on the dermatology safety monitoring board for ApoPharma and Eli Lilly.

dbrunk@frontlinemedcom.com

On Twitter @dougbrunk

Psoriatic arthritis patients with detectable anti-adalimumab antibodies have significantly lower serum adalimumab concentrations and poorer clinical outcomes at 28 weeks and 52 weeks of treatment, than did patients without antibodies in a prospective cohort study of 103 patients.

At week 52, the 23 patients with detectable anti-adalimumab antibodies had a median adalimumab concentration of 0.9 mg/L, compared with 9.4 mg/L in the 80 patients without detectable antibodies, as well as significantly higher C-reactive protein, Psoriasis Area Severity Index score, and 28-joint Disease Activity Score.

The researchers, led by Erik H. Vogelzang of the Jan van Breemen Research Institute/Reade in Amsterdam, also found that patients on adalimumab monotherapy had significantly lower median adalimumab concentrations at 28 and 52 weeks, compared with patients taking adalimumab and concomitant methotrexate (Ann. Rheum. Dis. 2014 [doi:10.1136/annrheumdis-2014-205554]).

"Further studies regarding measuring drug concentrations would be relevant, since this could give more insight on the cause of inadequate response, especially since treatment options in PsA [psoriatic arthritis] are limited," the investigators wrote.

The study was partly supported by AbbVie and Pfizer. The authors declared a range of consultancies, lecture fees, and research grants from the pharmaceutical industry.

Psoriatic arthritis patients with detectable anti-adalimumab antibodies have significantly lower serum adalimumab concentrations and poorer clinical outcomes at 28 weeks and 52 weeks of treatment, than did patients without antibodies in a prospective cohort study of 103 patients.

At week 52, the 23 patients with detectable anti-adalimumab antibodies had a median adalimumab concentration of 0.9 mg/L, compared with 9.4 mg/L in the 80 patients without detectable antibodies, as well as significantly higher C-reactive protein, Psoriasis Area Severity Index score, and 28-joint Disease Activity Score.

The researchers, led by Erik H. Vogelzang of the Jan van Breemen Research Institute/Reade in Amsterdam, also found that patients on adalimumab monotherapy had significantly lower median adalimumab concentrations at 28 and 52 weeks, compared with patients taking adalimumab and concomitant methotrexate (Ann. Rheum. Dis. 2014 [doi:10.1136/annrheumdis-2014-205554]).

"Further studies regarding measuring drug concentrations would be relevant, since this could give more insight on the cause of inadequate response, especially since treatment options in PsA [psoriatic arthritis] are limited," the investigators wrote.

The study was partly supported by AbbVie and Pfizer. The authors declared a range of consultancies, lecture fees, and research grants from the pharmaceutical industry.

Psoriatic arthritis patients with detectable anti-adalimumab antibodies have significantly lower serum adalimumab concentrations and poorer clinical outcomes at 28 weeks and 52 weeks of treatment, than did patients without antibodies in a prospective cohort study of 103 patients.

At week 52, the 23 patients with detectable anti-adalimumab antibodies had a median adalimumab concentration of 0.9 mg/L, compared with 9.4 mg/L in the 80 patients without detectable antibodies, as well as significantly higher C-reactive protein, Psoriasis Area Severity Index score, and 28-joint Disease Activity Score.

The researchers, led by Erik H. Vogelzang of the Jan van Breemen Research Institute/Reade in Amsterdam, also found that patients on adalimumab monotherapy had significantly lower median adalimumab concentrations at 28 and 52 weeks, compared with patients taking adalimumab and concomitant methotrexate (Ann. Rheum. Dis. 2014 [doi:10.1136/annrheumdis-2014-205554]).

"Further studies regarding measuring drug concentrations would be relevant, since this could give more insight on the cause of inadequate response, especially since treatment options in PsA [psoriatic arthritis] are limited," the investigators wrote.

The study was partly supported by AbbVie and Pfizer. The authors declared a range of consultancies, lecture fees, and research grants from the pharmaceutical industry.

BELLEVUE, WASH. – Women with autoimmune diseases who take corticosteroids and disease-modifying antirheumatic drugs later in pregnancy have an increased risk of preterm birth, but this association is largely explained by confounding with sociodemographic and clinical factors and disease severity, a study showed.

Researchers prospectively studied 678 pregnant women from the MotherToBaby database who had rheumatoid arthritis, psoriasis or psoriatic arthritis, ankylosing spondylitis, or Crohn’s disease. They focused on steroid use and disease-modifying antirheumatic drug (DMARD) use in the 16 weeks before delivery.

The results presented at the annual meeting of the Teratology Society showed that the incidence of preterm birth (birth before 37 weeks of gestation) was 19.2% among women using only steroids, 11.9% among those using only DMARDs, and 25.0% among those using both, compared with 11.2% among women who used neither throughout pregnancy.

In unadjusted analyses, women taking both steroids and DMARDs had significantly higher odds of preterm birth relative to peers who took neither (relative risk, 2.23), reported lead author Kristin Palmsten, Sc.D., of the University of California, San Diego.

But this risk was attenuated and no longer significant after adjustment for sociodemographic and clinical factors, such as age, race/ethnicity, parity, prior preterm birth, twin pregnancy, prepregnancy hypertension, depression, and use of nonsteroidal anti-inflammatory drugs.

It was attenuated further still after additional adjustment for the severity of autoimmune disease earlier in pregnancy, as assessed with the Health Assessment Questionnaire Disability Index (HAQ-DI) in analyses that excluded patients with Crohn’s disease (because they were not asked about disease severity).

The use of steroids alone and the use of DMARDs alone were not associated with a significantly elevated risk of preterm birth in either unadjusted or adjusted analyses.

The findings showed that confounders at least partially explain the heightened risk of preterm birth associated with autoimmune therapy, according to Dr. Palmsten.

A major study strength was exposure ascertainment, as the women were directly asked about their medication use several times during pregnancy, she noted. A limitation was the potential lack of generalizability, as the women studied were predominantly white and had higher socioeconomic status and lower disease severity.

In ongoing analyses, the investigators are looking at the proportions of preterm births that were spontaneous and medically indicated, and at the specific gestational age of the preterm births.

"I’d like to confirm the results in a different population; I’d like to look at this association in the Medicaid population, which is a low-income population," Dr. Palmsten added. "And I think preterm birth subtypes should be considered in further investigation. I’d also like to explore the timing of exposure and dose as well."

Session attendee Dr. Jan M. Friedman of the University of British Columbia in Vancouver noted the wide confidence intervals seen in analyses. "Obviously, that’s partially a function of the fact that the groups are fairly small. Is this an ongoing study? Will you have more data, more patients to look at in a year or something?" he asked.

"It is ongoing," Dr. Palmsten replied. "I don’t think that we’ll have 500 women exposed even after a year. But I do hope to address that with the Medicaid data because that would have a very large population."

Dr. Palmsten disclosed no relevant conflicts of interest. The MotherToBaby Pregnancy Study is sponsored by AbbVie, Amgen, Sanofi-Aventis, Apotex, Barr, Par Pharmaceutical, Sandoz, Teva, Bristol-Myers Squibb, Roche/Genentech, UCB Pharma, Pfizer, and Janssen.

BELLEVUE, WASH. – Women with autoimmune diseases who take corticosteroids and disease-modifying antirheumatic drugs later in pregnancy have an increased risk of preterm birth, but this association is largely explained by confounding with sociodemographic and clinical factors and disease severity, a study showed.

Researchers prospectively studied 678 pregnant women from the MotherToBaby database who had rheumatoid arthritis, psoriasis or psoriatic arthritis, ankylosing spondylitis, or Crohn’s disease. They focused on steroid use and disease-modifying antirheumatic drug (DMARD) use in the 16 weeks before delivery.

The results presented at the annual meeting of the Teratology Society showed that the incidence of preterm birth (birth before 37 weeks of gestation) was 19.2% among women using only steroids, 11.9% among those using only DMARDs, and 25.0% among those using both, compared with 11.2% among women who used neither throughout pregnancy.

In unadjusted analyses, women taking both steroids and DMARDs had significantly higher odds of preterm birth relative to peers who took neither (relative risk, 2.23), reported lead author Kristin Palmsten, Sc.D., of the University of California, San Diego.

But this risk was attenuated and no longer significant after adjustment for sociodemographic and clinical factors, such as age, race/ethnicity, parity, prior preterm birth, twin pregnancy, prepregnancy hypertension, depression, and use of nonsteroidal anti-inflammatory drugs.

It was attenuated further still after additional adjustment for the severity of autoimmune disease earlier in pregnancy, as assessed with the Health Assessment Questionnaire Disability Index (HAQ-DI) in analyses that excluded patients with Crohn’s disease (because they were not asked about disease severity).

The use of steroids alone and the use of DMARDs alone were not associated with a significantly elevated risk of preterm birth in either unadjusted or adjusted analyses.

The findings showed that confounders at least partially explain the heightened risk of preterm birth associated with autoimmune therapy, according to Dr. Palmsten.

A major study strength was exposure ascertainment, as the women were directly asked about their medication use several times during pregnancy, she noted. A limitation was the potential lack of generalizability, as the women studied were predominantly white and had higher socioeconomic status and lower disease severity.

In ongoing analyses, the investigators are looking at the proportions of preterm births that were spontaneous and medically indicated, and at the specific gestational age of the preterm births.

"I’d like to confirm the results in a different population; I’d like to look at this association in the Medicaid population, which is a low-income population," Dr. Palmsten added. "And I think preterm birth subtypes should be considered in further investigation. I’d also like to explore the timing of exposure and dose as well."

Session attendee Dr. Jan M. Friedman of the University of British Columbia in Vancouver noted the wide confidence intervals seen in analyses. "Obviously, that’s partially a function of the fact that the groups are fairly small. Is this an ongoing study? Will you have more data, more patients to look at in a year or something?" he asked.

"It is ongoing," Dr. Palmsten replied. "I don’t think that we’ll have 500 women exposed even after a year. But I do hope to address that with the Medicaid data because that would have a very large population."

Dr. Palmsten disclosed no relevant conflicts of interest. The MotherToBaby Pregnancy Study is sponsored by AbbVie, Amgen, Sanofi-Aventis, Apotex, Barr, Par Pharmaceutical, Sandoz, Teva, Bristol-Myers Squibb, Roche/Genentech, UCB Pharma, Pfizer, and Janssen.

BELLEVUE, WASH. – Women with autoimmune diseases who take corticosteroids and disease-modifying antirheumatic drugs later in pregnancy have an increased risk of preterm birth, but this association is largely explained by confounding with sociodemographic and clinical factors and disease severity, a study showed.

Researchers prospectively studied 678 pregnant women from the MotherToBaby database who had rheumatoid arthritis, psoriasis or psoriatic arthritis, ankylosing spondylitis, or Crohn’s disease. They focused on steroid use and disease-modifying antirheumatic drug (DMARD) use in the 16 weeks before delivery.

The results presented at the annual meeting of the Teratology Society showed that the incidence of preterm birth (birth before 37 weeks of gestation) was 19.2% among women using only steroids, 11.9% among those using only DMARDs, and 25.0% among those using both, compared with 11.2% among women who used neither throughout pregnancy.

In unadjusted analyses, women taking both steroids and DMARDs had significantly higher odds of preterm birth relative to peers who took neither (relative risk, 2.23), reported lead author Kristin Palmsten, Sc.D., of the University of California, San Diego.

But this risk was attenuated and no longer significant after adjustment for sociodemographic and clinical factors, such as age, race/ethnicity, parity, prior preterm birth, twin pregnancy, prepregnancy hypertension, depression, and use of nonsteroidal anti-inflammatory drugs.

It was attenuated further still after additional adjustment for the severity of autoimmune disease earlier in pregnancy, as assessed with the Health Assessment Questionnaire Disability Index (HAQ-DI) in analyses that excluded patients with Crohn’s disease (because they were not asked about disease severity).

The use of steroids alone and the use of DMARDs alone were not associated with a significantly elevated risk of preterm birth in either unadjusted or adjusted analyses.

The findings showed that confounders at least partially explain the heightened risk of preterm birth associated with autoimmune therapy, according to Dr. Palmsten.

A major study strength was exposure ascertainment, as the women were directly asked about their medication use several times during pregnancy, she noted. A limitation was the potential lack of generalizability, as the women studied were predominantly white and had higher socioeconomic status and lower disease severity.

In ongoing analyses, the investigators are looking at the proportions of preterm births that were spontaneous and medically indicated, and at the specific gestational age of the preterm births.

"I’d like to confirm the results in a different population; I’d like to look at this association in the Medicaid population, which is a low-income population," Dr. Palmsten added. "And I think preterm birth subtypes should be considered in further investigation. I’d also like to explore the timing of exposure and dose as well."

Session attendee Dr. Jan M. Friedman of the University of British Columbia in Vancouver noted the wide confidence intervals seen in analyses. "Obviously, that’s partially a function of the fact that the groups are fairly small. Is this an ongoing study? Will you have more data, more patients to look at in a year or something?" he asked.

"It is ongoing," Dr. Palmsten replied. "I don’t think that we’ll have 500 women exposed even after a year. But I do hope to address that with the Medicaid data because that would have a very large population."

Dr. Palmsten disclosed no relevant conflicts of interest. The MotherToBaby Pregnancy Study is sponsored by AbbVie, Amgen, Sanofi-Aventis, Apotex, Barr, Par Pharmaceutical, Sandoz, Teva, Bristol-Myers Squibb, Roche/Genentech, UCB Pharma, Pfizer, and Janssen.

NEW YORK – A research consortium in psoriatic arthritis has been recently organized by a group of researchers at academic centers hoping to accelerate data collection by pooling resources.

Formed about 1 year ago, the research group, called PPACMAN (Psoriasis and Psoriatic Arthritis Clinics Multicenter Advancement Network) is currently open to those centers in which dermatologists and rheumatologists are already collaborating in the management of psoriatic arthritis (PsA).

"One of the advantages of this group is that we hope to pursue research goals with minimal costs and need for funding," explained Dr. Jose U. Scher, director of the arthritis clinic and codirector of the psoriatic arthritis center at NYU Langone Medical Center, New York. In addition to NYU, the collaborating centers include the Cleveland Clinic; the National Institutes of Health; the University of Pennsylvania, Philadelphia; the University of Utah, Salt Lake City; the University of Toronto, Harvard University’s Brigham and Women’s Hospital, Boston; North Shore-Long Island Jewish Health System, Manhasset, N.Y.; Oregon Health & Science University, Portland; the University of Rochester, N.Y.; and the National Psoriasis Foundation, Portland.

In outlining progress so far at the joint meetings of the Group for Research and Assessment of Psoriasis and Psoriatic Arthritis and the Spondyloarthritis Research & Treatment Network, Dr. Scher reported on three initiatives underway.

Of these, the most ambitious may be a multicenter longitudinal cohort being created by collating electronic medical records of PsA patients from the participating centers. As it grows over time, this database has the potential to serve as a rich resource of information on PsA characteristics, treatment approaches, and outcomes.

"This is an example of how we can leverage data in PsA through collaboration with resources already devoted to clinical care," Dr. Scher reported. By collating the data from electronic medical records in compatible formats, the cohort data to some degree will collect themselves.

In addition, PPACMAN centers are participating in an effort to evaluate tools used by dermatologists to screen for PsA. According to Dr. Scher, this initiative is the first step in an effort to work toward identifying the screening approaches that are most effective.

"It is still unclear which tools are being used and their relative value for early detection of PsA in a practical sense," said Dr. Scher, referring to such screening instruments as the Psoriasis Arthritis Screening Evaluation. The goal is to document how instruments are being used currently and then to define strategies that best accelerate the time to diagnosis.

A third project being developed by the PPACMAN collaborative group involves the study of biomarkers. Biomarkers have enormous potential for predicting the course of PsA and guiding therapy, but the complex interaction of genetic, environmental, and immunologic factors complicates the effort to isolate their independent predictive value. In attempting to control for variables, studies conducted with a relatively large number of patients have a practical advantage.

"The principle of PPACMAN, integrated by highly driven and talented researchers, is that we can achieve more by working together," Dr. Scher explained. Indeed, he said that other centers with an interest in PsA are welcome to join as long as they have a program in which dermatologists and rheumatologists collaborate.

"This is a relatively new initiative, but we are excited about its potential," Dr. Scher said.

Dr. Scher reported no relevant financial relationships.

NEW YORK – A research consortium in psoriatic arthritis has been recently organized by a group of researchers at academic centers hoping to accelerate data collection by pooling resources.

Formed about 1 year ago, the research group, called PPACMAN (Psoriasis and Psoriatic Arthritis Clinics Multicenter Advancement Network) is currently open to those centers in which dermatologists and rheumatologists are already collaborating in the management of psoriatic arthritis (PsA).

"One of the advantages of this group is that we hope to pursue research goals with minimal costs and need for funding," explained Dr. Jose U. Scher, director of the arthritis clinic and codirector of the psoriatic arthritis center at NYU Langone Medical Center, New York. In addition to NYU, the collaborating centers include the Cleveland Clinic; the National Institutes of Health; the University of Pennsylvania, Philadelphia; the University of Utah, Salt Lake City; the University of Toronto, Harvard University’s Brigham and Women’s Hospital, Boston; North Shore-Long Island Jewish Health System, Manhasset, N.Y.; Oregon Health & Science University, Portland; the University of Rochester, N.Y.; and the National Psoriasis Foundation, Portland.

In outlining progress so far at the joint meetings of the Group for Research and Assessment of Psoriasis and Psoriatic Arthritis and the Spondyloarthritis Research & Treatment Network, Dr. Scher reported on three initiatives underway.

Of these, the most ambitious may be a multicenter longitudinal cohort being created by collating electronic medical records of PsA patients from the participating centers. As it grows over time, this database has the potential to serve as a rich resource of information on PsA characteristics, treatment approaches, and outcomes.

"This is an example of how we can leverage data in PsA through collaboration with resources already devoted to clinical care," Dr. Scher reported. By collating the data from electronic medical records in compatible formats, the cohort data to some degree will collect themselves.

In addition, PPACMAN centers are participating in an effort to evaluate tools used by dermatologists to screen for PsA. According to Dr. Scher, this initiative is the first step in an effort to work toward identifying the screening approaches that are most effective.

"It is still unclear which tools are being used and their relative value for early detection of PsA in a practical sense," said Dr. Scher, referring to such screening instruments as the Psoriasis Arthritis Screening Evaluation. The goal is to document how instruments are being used currently and then to define strategies that best accelerate the time to diagnosis.

A third project being developed by the PPACMAN collaborative group involves the study of biomarkers. Biomarkers have enormous potential for predicting the course of PsA and guiding therapy, but the complex interaction of genetic, environmental, and immunologic factors complicates the effort to isolate their independent predictive value. In attempting to control for variables, studies conducted with a relatively large number of patients have a practical advantage.

"The principle of PPACMAN, integrated by highly driven and talented researchers, is that we can achieve more by working together," Dr. Scher explained. Indeed, he said that other centers with an interest in PsA are welcome to join as long as they have a program in which dermatologists and rheumatologists collaborate.

"This is a relatively new initiative, but we are excited about its potential," Dr. Scher said.

Dr. Scher reported no relevant financial relationships.

NEW YORK – A research consortium in psoriatic arthritis has been recently organized by a group of researchers at academic centers hoping to accelerate data collection by pooling resources.

Formed about 1 year ago, the research group, called PPACMAN (Psoriasis and Psoriatic Arthritis Clinics Multicenter Advancement Network) is currently open to those centers in which dermatologists and rheumatologists are already collaborating in the management of psoriatic arthritis (PsA).

"One of the advantages of this group is that we hope to pursue research goals with minimal costs and need for funding," explained Dr. Jose U. Scher, director of the arthritis clinic and codirector of the psoriatic arthritis center at NYU Langone Medical Center, New York. In addition to NYU, the collaborating centers include the Cleveland Clinic; the National Institutes of Health; the University of Pennsylvania, Philadelphia; the University of Utah, Salt Lake City; the University of Toronto, Harvard University’s Brigham and Women’s Hospital, Boston; North Shore-Long Island Jewish Health System, Manhasset, N.Y.; Oregon Health & Science University, Portland; the University of Rochester, N.Y.; and the National Psoriasis Foundation, Portland.

In outlining progress so far at the joint meetings of the Group for Research and Assessment of Psoriasis and Psoriatic Arthritis and the Spondyloarthritis Research & Treatment Network, Dr. Scher reported on three initiatives underway.

Of these, the most ambitious may be a multicenter longitudinal cohort being created by collating electronic medical records of PsA patients from the participating centers. As it grows over time, this database has the potential to serve as a rich resource of information on PsA characteristics, treatment approaches, and outcomes.

"This is an example of how we can leverage data in PsA through collaboration with resources already devoted to clinical care," Dr. Scher reported. By collating the data from electronic medical records in compatible formats, the cohort data to some degree will collect themselves.

In addition, PPACMAN centers are participating in an effort to evaluate tools used by dermatologists to screen for PsA. According to Dr. Scher, this initiative is the first step in an effort to work toward identifying the screening approaches that are most effective.

"It is still unclear which tools are being used and their relative value for early detection of PsA in a practical sense," said Dr. Scher, referring to such screening instruments as the Psoriasis Arthritis Screening Evaluation. The goal is to document how instruments are being used currently and then to define strategies that best accelerate the time to diagnosis.

A third project being developed by the PPACMAN collaborative group involves the study of biomarkers. Biomarkers have enormous potential for predicting the course of PsA and guiding therapy, but the complex interaction of genetic, environmental, and immunologic factors complicates the effort to isolate their independent predictive value. In attempting to control for variables, studies conducted with a relatively large number of patients have a practical advantage.

"The principle of PPACMAN, integrated by highly driven and talented researchers, is that we can achieve more by working together," Dr. Scher explained. Indeed, he said that other centers with an interest in PsA are welcome to join as long as they have a program in which dermatologists and rheumatologists collaborate.

"This is a relatively new initiative, but we are excited about its potential," Dr. Scher said.

Dr. Scher reported no relevant financial relationships.

NEW YORK – Axial spondyloarthritis is not being seen by U.S. rheumatologists at a rate commensurate with prevalence, according to an expert providing the rationale for a major educational initiative.

In the United States, several studies, including the most recent, suggest that the prevalence of axSpA is at least as great as that of rheumatoid arthritis even though most rheumatologists see a much lower proportion of axSpA patients, according to Dr. Atul Deodhar, medical director of the rheumatology clinics at Oregon Health & Science University, Portland.

The reasons for this disparity are not fully understood, but it has prompted a major educational initiative by the Spondyloarthritis Research & Treatment Network (SPARTAN), according to Dr. Deodhar, who spoke at the joint meetings of SPARTAN and the Group for Research and Assessment of Psoriasis and Psoriatic Arthritis. The goal of the initiative is to reduce the delay to diagnosis and to funnel these patients more efficiently to experts in inflammatory joint diseases.

The most recent U.S. prevalence estimate for axSpA is 0.7%, reported Dr. Deodhar, citing a study that employed Assessment of Spondyloarthritis International Society (ASAS) criteria (Arthritis Care Res. 2013;65:1299-306). Other studies have generated prevalence rates as high as 1.4%, but even this lower recent estimate exceeds the typically cited 0.6% estimated prevalence rate for RA, he said.

"One wonders where these patients are going," said Dr. Deodhar, emphasizing the relative infrequency with which axSpA is managed by U.S. rheumatologists.

Some of these patients are likely to be seen by orthopedists, chiropractors, internists, or other health care providers, but one concern is that many are not being seen at all or at least not until the disease has advanced. Dr. Deodhar cited evidence that the average delay to diagnosis of axSpA in the United States is 6-8 years, which is likely to worsen outcome.

"Several studies suggest that partial remission is about double when patients are caught early and treated appropriately," Dr. Deodhar said. However, although rheumatologists are in the best position to help axSpA patients, they might be part of the problem, he said.

"Rheumatologists have traditionally shied away from seeing patients with back pain, because 95% of these patients have mechanical pain for which rheumatologists do not have much to offer," Dr. Deodhar said.

Yet for those with an inflammatory etiology, rheumatologists can play an essential role in treatment that slows or halts progression. A SPARTAN initiative has been specifically planned to educate those health care providers likely to hear initial complaints of lower back pain as well as to increase attention to axSpA by rheumatologists.

For referral physicians, the initiatives are being focused on increasing awareness of inflammatory back pain and providing simple criteria for referral, according to Dr. Deodhar. The ASAS diagnostic criteria for axSpA are considered sensitive and specific, but simplified referral strategies may accelerate the time to a specialist consultation.

Several referral strategies are effective. Dr. Deodhar cited one study that tested two. In one strategy, a referral was made in patients younger than 45, with chronic back pain of at least 3 months, who met two of three screening criteria: inflammatory back pain, HLA-B27 positivity, or sacroiliitis on imaging. In the other, the same criteria were employed and patients had to have a positive family history of ankylosing spondylitis or a good treatment response to NSAIDs (J. Rheumatol. 2011;38:2452-60).

With the first strategy, "nearly 42% [41.8%] had definite axSpA," according to Dr. Deodhar. The slightly lower sensitivity of the other was not inferior statistically, but the first strategy was preferred for simplicity.

These types of referral strategies will be included in the SPARTAN educational initiatives being developed to improve early recognition of axSpA and to bring patients to the specialists most suited to offering effective management.

Dr. Deodhar reported financial relationships with Amgen, Abbott, Genentech, and Janssen.

NEW YORK – Axial spondyloarthritis is not being seen by U.S. rheumatologists at a rate commensurate with prevalence, according to an expert providing the rationale for a major educational initiative.

In the United States, several studies, including the most recent, suggest that the prevalence of axSpA is at least as great as that of rheumatoid arthritis even though most rheumatologists see a much lower proportion of axSpA patients, according to Dr. Atul Deodhar, medical director of the rheumatology clinics at Oregon Health & Science University, Portland.

The reasons for this disparity are not fully understood, but it has prompted a major educational initiative by the Spondyloarthritis Research & Treatment Network (SPARTAN), according to Dr. Deodhar, who spoke at the joint meetings of SPARTAN and the Group for Research and Assessment of Psoriasis and Psoriatic Arthritis. The goal of the initiative is to reduce the delay to diagnosis and to funnel these patients more efficiently to experts in inflammatory joint diseases.

The most recent U.S. prevalence estimate for axSpA is 0.7%, reported Dr. Deodhar, citing a study that employed Assessment of Spondyloarthritis International Society (ASAS) criteria (Arthritis Care Res. 2013;65:1299-306). Other studies have generated prevalence rates as high as 1.4%, but even this lower recent estimate exceeds the typically cited 0.6% estimated prevalence rate for RA, he said.

"One wonders where these patients are going," said Dr. Deodhar, emphasizing the relative infrequency with which axSpA is managed by U.S. rheumatologists.

Some of these patients are likely to be seen by orthopedists, chiropractors, internists, or other health care providers, but one concern is that many are not being seen at all or at least not until the disease has advanced. Dr. Deodhar cited evidence that the average delay to diagnosis of axSpA in the United States is 6-8 years, which is likely to worsen outcome.

"Several studies suggest that partial remission is about double when patients are caught early and treated appropriately," Dr. Deodhar said. However, although rheumatologists are in the best position to help axSpA patients, they might be part of the problem, he said.

"Rheumatologists have traditionally shied away from seeing patients with back pain, because 95% of these patients have mechanical pain for which rheumatologists do not have much to offer," Dr. Deodhar said.

Yet for those with an inflammatory etiology, rheumatologists can play an essential role in treatment that slows or halts progression. A SPARTAN initiative has been specifically planned to educate those health care providers likely to hear initial complaints of lower back pain as well as to increase attention to axSpA by rheumatologists.

For referral physicians, the initiatives are being focused on increasing awareness of inflammatory back pain and providing simple criteria for referral, according to Dr. Deodhar. The ASAS diagnostic criteria for axSpA are considered sensitive and specific, but simplified referral strategies may accelerate the time to a specialist consultation.

Several referral strategies are effective. Dr. Deodhar cited one study that tested two. In one strategy, a referral was made in patients younger than 45, with chronic back pain of at least 3 months, who met two of three screening criteria: inflammatory back pain, HLA-B27 positivity, or sacroiliitis on imaging. In the other, the same criteria were employed and patients had to have a positive family history of ankylosing spondylitis or a good treatment response to NSAIDs (J. Rheumatol. 2011;38:2452-60).

With the first strategy, "nearly 42% [41.8%] had definite axSpA," according to Dr. Deodhar. The slightly lower sensitivity of the other was not inferior statistically, but the first strategy was preferred for simplicity.

These types of referral strategies will be included in the SPARTAN educational initiatives being developed to improve early recognition of axSpA and to bring patients to the specialists most suited to offering effective management.

Dr. Deodhar reported financial relationships with Amgen, Abbott, Genentech, and Janssen.

NEW YORK – Axial spondyloarthritis is not being seen by U.S. rheumatologists at a rate commensurate with prevalence, according to an expert providing the rationale for a major educational initiative.

In the United States, several studies, including the most recent, suggest that the prevalence of axSpA is at least as great as that of rheumatoid arthritis even though most rheumatologists see a much lower proportion of axSpA patients, according to Dr. Atul Deodhar, medical director of the rheumatology clinics at Oregon Health & Science University, Portland.

The reasons for this disparity are not fully understood, but it has prompted a major educational initiative by the Spondyloarthritis Research & Treatment Network (SPARTAN), according to Dr. Deodhar, who spoke at the joint meetings of SPARTAN and the Group for Research and Assessment of Psoriasis and Psoriatic Arthritis. The goal of the initiative is to reduce the delay to diagnosis and to funnel these patients more efficiently to experts in inflammatory joint diseases.

The most recent U.S. prevalence estimate for axSpA is 0.7%, reported Dr. Deodhar, citing a study that employed Assessment of Spondyloarthritis International Society (ASAS) criteria (Arthritis Care Res. 2013;65:1299-306). Other studies have generated prevalence rates as high as 1.4%, but even this lower recent estimate exceeds the typically cited 0.6% estimated prevalence rate for RA, he said.

"One wonders where these patients are going," said Dr. Deodhar, emphasizing the relative infrequency with which axSpA is managed by U.S. rheumatologists.

Some of these patients are likely to be seen by orthopedists, chiropractors, internists, or other health care providers, but one concern is that many are not being seen at all or at least not until the disease has advanced. Dr. Deodhar cited evidence that the average delay to diagnosis of axSpA in the United States is 6-8 years, which is likely to worsen outcome.

"Several studies suggest that partial remission is about double when patients are caught early and treated appropriately," Dr. Deodhar said. However, although rheumatologists are in the best position to help axSpA patients, they might be part of the problem, he said.

"Rheumatologists have traditionally shied away from seeing patients with back pain, because 95% of these patients have mechanical pain for which rheumatologists do not have much to offer," Dr. Deodhar said.

Yet for those with an inflammatory etiology, rheumatologists can play an essential role in treatment that slows or halts progression. A SPARTAN initiative has been specifically planned to educate those health care providers likely to hear initial complaints of lower back pain as well as to increase attention to axSpA by rheumatologists.

For referral physicians, the initiatives are being focused on increasing awareness of inflammatory back pain and providing simple criteria for referral, according to Dr. Deodhar. The ASAS diagnostic criteria for axSpA are considered sensitive and specific, but simplified referral strategies may accelerate the time to a specialist consultation.

Several referral strategies are effective. Dr. Deodhar cited one study that tested two. In one strategy, a referral was made in patients younger than 45, with chronic back pain of at least 3 months, who met two of three screening criteria: inflammatory back pain, HLA-B27 positivity, or sacroiliitis on imaging. In the other, the same criteria were employed and patients had to have a positive family history of ankylosing spondylitis or a good treatment response to NSAIDs (J. Rheumatol. 2011;38:2452-60).

With the first strategy, "nearly 42% [41.8%] had definite axSpA," according to Dr. Deodhar. The slightly lower sensitivity of the other was not inferior statistically, but the first strategy was preferred for simplicity.

These types of referral strategies will be included in the SPARTAN educational initiatives being developed to improve early recognition of axSpA and to bring patients to the specialists most suited to offering effective management.

Dr. Deodhar reported financial relationships with Amgen, Abbott, Genentech, and Janssen.

NEW YORK – Patients with ankylosing spondylitis who used opiate analgesics were five times more likely to report depression than were those who did not, in a retrospective case-control study of 611 patients.

The relationship between opiate usage and depression was significant even though those who took antidepressants or anxiolytics were significantly less likely to use opiates, according to Dr. Jonathan D. Dau of the department of rheumatology at the University of Texas, Houston.

In the study, there were several highly significant distinctions between those who used opiate analgesics and those who did not, but none could be connected to inflammatory activity, Dr. Dau said.

"None of the objective measures of AS [ankylosing spondylitis] disease activity or progression were found to be associated with opiate usage. This adds confirmation to the hypothesis that pain associated with AS may develop from sources other than spinal inflammation alone," he said.

In data presented at the joint meetings of the Group for Research and Assessment of Psoriasis and Psoriatic Arthritis and the Spondyloarthritis Research & Treatment Network, a large variety of parameters were compared between the 87 patients who took opiate analgesics intermittently (91%) or continuously (9%) and the remaining 524 who never took opiate analgesics over a follow-up period of up to 4 years. Three centers in addition to the University of Texas contributed AS patients to the analysis. The mean disease duration was 17.6 years.

Although there were no significant differences between users and nonusers of opiates for radiographic severity, as measured with the modified Stoke Ankylosing Spondylitis Spinal Score, or inflammation, as measured with C-reactive protein levels or erythrocyte sedimentation rate, opiate users scored high on subjective measures. Specifically, the odds ratio for a Bath AS Disease Activity Index score of 4 or greater was 5.460 (P less than .0001). The OR for a high patient global pain assessment was 4.240 (P less than .0001).

As for depression, the OR for opiate users relative to nonopiate users was 5.907 (P less than .0001) by self-report and 3.071 (P less than .0001) by the Center for Epidemiologic Study Depression scale. The authors also reported an OR for smoking among opiate users of 2.125 (P = .0018).

Conversely, an analysis of concomitant medication use found that antidepressants correlated with a 63% reduction (OR, 0.371; P = .0004) in the likelihood of opiate use. Anxiolytics correlated with a nearly 90% reduction (OR, 0.124; P less than .0001). There was no significant association with opiate use and use of either NSAIDs or tumor necrosis factor inhibitors.

However, the study found that opiate users were almost three times more likely to be taking prednisone (OR, 2.996; P = .0073) and more than eight times more likely to be taking muscle relaxants (OR, 8.458; P less than .0001). Dr. Dau observed that muscle relaxants on top of opiates "may provide a greater magnitude of pain relief taken together than when taken alone."

Because of the concerns about use of opiates, particularly their propensity to induce dependence, Dr. Dau suggested that it is important to further explore why some patients take these agents in addition to treatments targeted at disease activity. While standard medications such as NSAIDs and TNF inhibitors have been shown to relieve pain, they do not control somatic pain for all patients.

"This is especially true when the pain stems from processes other than inflammation," reported Dr. Dau. More data are needed to determine whether control of depression through antidepressants is a factor for reducing opiate use, he said.

Dr. Dau reported no relevant financial disclosures.

NEW YORK – Patients with ankylosing spondylitis who used opiate analgesics were five times more likely to report depression than were those who did not, in a retrospective case-control study of 611 patients.

The relationship between opiate usage and depression was significant even though those who took antidepressants or anxiolytics were significantly less likely to use opiates, according to Dr. Jonathan D. Dau of the department of rheumatology at the University of Texas, Houston.

In the study, there were several highly significant distinctions between those who used opiate analgesics and those who did not, but none could be connected to inflammatory activity, Dr. Dau said.

"None of the objective measures of AS [ankylosing spondylitis] disease activity or progression were found to be associated with opiate usage. This adds confirmation to the hypothesis that pain associated with AS may develop from sources other than spinal inflammation alone," he said.

In data presented at the joint meetings of the Group for Research and Assessment of Psoriasis and Psoriatic Arthritis and the Spondyloarthritis Research & Treatment Network, a large variety of parameters were compared between the 87 patients who took opiate analgesics intermittently (91%) or continuously (9%) and the remaining 524 who never took opiate analgesics over a follow-up period of up to 4 years. Three centers in addition to the University of Texas contributed AS patients to the analysis. The mean disease duration was 17.6 years.

Although there were no significant differences between users and nonusers of opiates for radiographic severity, as measured with the modified Stoke Ankylosing Spondylitis Spinal Score, or inflammation, as measured with C-reactive protein levels or erythrocyte sedimentation rate, opiate users scored high on subjective measures. Specifically, the odds ratio for a Bath AS Disease Activity Index score of 4 or greater was 5.460 (P less than .0001). The OR for a high patient global pain assessment was 4.240 (P less than .0001).

As for depression, the OR for opiate users relative to nonopiate users was 5.907 (P less than .0001) by self-report and 3.071 (P less than .0001) by the Center for Epidemiologic Study Depression scale. The authors also reported an OR for smoking among opiate users of 2.125 (P = .0018).

Conversely, an analysis of concomitant medication use found that antidepressants correlated with a 63% reduction (OR, 0.371; P = .0004) in the likelihood of opiate use. Anxiolytics correlated with a nearly 90% reduction (OR, 0.124; P less than .0001). There was no significant association with opiate use and use of either NSAIDs or tumor necrosis factor inhibitors.

However, the study found that opiate users were almost three times more likely to be taking prednisone (OR, 2.996; P = .0073) and more than eight times more likely to be taking muscle relaxants (OR, 8.458; P less than .0001). Dr. Dau observed that muscle relaxants on top of opiates "may provide a greater magnitude of pain relief taken together than when taken alone."

Because of the concerns about use of opiates, particularly their propensity to induce dependence, Dr. Dau suggested that it is important to further explore why some patients take these agents in addition to treatments targeted at disease activity. While standard medications such as NSAIDs and TNF inhibitors have been shown to relieve pain, they do not control somatic pain for all patients.

"This is especially true when the pain stems from processes other than inflammation," reported Dr. Dau. More data are needed to determine whether control of depression through antidepressants is a factor for reducing opiate use, he said.

Dr. Dau reported no relevant financial disclosures.

NEW YORK – Patients with ankylosing spondylitis who used opiate analgesics were five times more likely to report depression than were those who did not, in a retrospective case-control study of 611 patients.

The relationship between opiate usage and depression was significant even though those who took antidepressants or anxiolytics were significantly less likely to use opiates, according to Dr. Jonathan D. Dau of the department of rheumatology at the University of Texas, Houston.

In the study, there were several highly significant distinctions between those who used opiate analgesics and those who did not, but none could be connected to inflammatory activity, Dr. Dau said.

"None of the objective measures of AS [ankylosing spondylitis] disease activity or progression were found to be associated with opiate usage. This adds confirmation to the hypothesis that pain associated with AS may develop from sources other than spinal inflammation alone," he said.

In data presented at the joint meetings of the Group for Research and Assessment of Psoriasis and Psoriatic Arthritis and the Spondyloarthritis Research & Treatment Network, a large variety of parameters were compared between the 87 patients who took opiate analgesics intermittently (91%) or continuously (9%) and the remaining 524 who never took opiate analgesics over a follow-up period of up to 4 years. Three centers in addition to the University of Texas contributed AS patients to the analysis. The mean disease duration was 17.6 years.

Although there were no significant differences between users and nonusers of opiates for radiographic severity, as measured with the modified Stoke Ankylosing Spondylitis Spinal Score, or inflammation, as measured with C-reactive protein levels or erythrocyte sedimentation rate, opiate users scored high on subjective measures. Specifically, the odds ratio for a Bath AS Disease Activity Index score of 4 or greater was 5.460 (P less than .0001). The OR for a high patient global pain assessment was 4.240 (P less than .0001).

As for depression, the OR for opiate users relative to nonopiate users was 5.907 (P less than .0001) by self-report and 3.071 (P less than .0001) by the Center for Epidemiologic Study Depression scale. The authors also reported an OR for smoking among opiate users of 2.125 (P = .0018).

Conversely, an analysis of concomitant medication use found that antidepressants correlated with a 63% reduction (OR, 0.371; P = .0004) in the likelihood of opiate use. Anxiolytics correlated with a nearly 90% reduction (OR, 0.124; P less than .0001). There was no significant association with opiate use and use of either NSAIDs or tumor necrosis factor inhibitors.

However, the study found that opiate users were almost three times more likely to be taking prednisone (OR, 2.996; P = .0073) and more than eight times more likely to be taking muscle relaxants (OR, 8.458; P less than .0001). Dr. Dau observed that muscle relaxants on top of opiates "may provide a greater magnitude of pain relief taken together than when taken alone."

Because of the concerns about use of opiates, particularly their propensity to induce dependence, Dr. Dau suggested that it is important to further explore why some patients take these agents in addition to treatments targeted at disease activity. While standard medications such as NSAIDs and TNF inhibitors have been shown to relieve pain, they do not control somatic pain for all patients.

"This is especially true when the pain stems from processes other than inflammation," reported Dr. Dau. More data are needed to determine whether control of depression through antidepressants is a factor for reducing opiate use, he said.

Dr. Dau reported no relevant financial disclosures.

NEW YORK – Consistent evidence for a substantial increase in cardiovascular events remains elusive for patients with ankylosing spondylitis who have a broad range of CV risk factors.

"We can all agree that the risk factors for cardiovascular disease are higher in patients with AS [ankylosing spondylitis], but I think it is more controversial whether every AS patient faces a higher risk of events," observed Dr. Lianne Gensler, director of the ankylosing spondylitis clinic at the University of California, San Francisco.

Although this statement was made in reference to ischemic heart disease, the analysis presented by Dr. Gensler at the joint meetings of the Group for Research and Assessment of Psoriasis and Psoriatic Arthritis and the Spondyloarthritis Research & Treatment Network appears to be relevant to valvular disease, arrhythmias, and left ventricular dysfunction. Other CV risk factors associated with AS include hypertension, aortic insufficiency, and conduction disorders.

Inconsistencies in studies of CV

The obstacle for drawing conclusions is the lack of consistency in the published studies that relate specifically to AS but are independent of other inflammatory joint diseases, such as rheumatoid arthritis. In a review, Dr. Gensler cited one meta-analysis of 17 studies published in 2011 that did not associate AS with increased CV events (Arthritis Care Res. 2011;63:557-63). Although several studies published subsequently did associate AS with an increased rate of events, there were others that did not.

In an analysis that was performed at her institution based on AS patient data from the Healthcare Cost and Utilization Project National Inpatient Sample, no difference could be found in in-hospital mortality due to CV events when AS patients were compared with non-AS patients stratified by age.

In regard to CV structural disease related to AS, there is substantial evidence that several abnormalities are more common in AS, but there is far less to document that these lead to an increased risk of events. For example, Dr. Gensler cited one study in which the prevalence of aortic insufficiency climbed from 2% in patients with 10 years’ AS duration to 12% in those with 30 years. In another, inflammation of the septum, a potential risk for conduction disorders, climbed from 3% to 90% in AS patients followed long-term.

Asymptomatic conduction disorders

Conduction disorders in general – and QRS disturbances in particular – have been commonly reported in AS patients, but typically in the absence of symptoms, according to Dr. Gensler. She cited one electrocardiogram study in which 30% of AS patients had QRS prolongation, but all were asymptomatic. In another study of 200 AS patients, conduction disorders were found in 33%, of which atrioventricular block was the most common. In this study, increased markers of inflammation did not correlate with conduction disorders in a multivariate analysis.

"Whether we should be doing anything to look for these [conduction disorders] when they do not have symptoms is a question that I will put out to the audience," Dr. Gensler said.

Effect of treatment on CV events

The effect of AS therapies, particularly tumor necrosis factor (TNF) inhibitors, on CV risk also remains incompletely understood. In one study cited by Dr. Gensler, improved endothelial function was observed in AS patients treated with a TNF inhibitor, suggesting a potential protective effect, but, again, no difference in event rates in AS patients has ever been documented between those on TNF inhibitors and those not on TNF inhibitors.

Overall, more data are needed to determine the effect of AS on the risk of CV events, but one risk factor deserves attention even if there is no specific evidence that it affects CV events, according to Dr. Gensler.

In AS, "we know that smoking is a risk for early-onset disease, more inflammation, more damage, and more progression, so I think this [smoking cessation] is one guideline we can take to heart and take home to our patients," she said.

Dr. Gensler reported financial relationships with UCB and AbbVie.

NEW YORK – Consistent evidence for a substantial increase in cardiovascular events remains elusive for patients with ankylosing spondylitis who have a broad range of CV risk factors.

"We can all agree that the risk factors for cardiovascular disease are higher in patients with AS [ankylosing spondylitis], but I think it is more controversial whether every AS patient faces a higher risk of events," observed Dr. Lianne Gensler, director of the ankylosing spondylitis clinic at the University of California, San Francisco.

Although this statement was made in reference to ischemic heart disease, the analysis presented by Dr. Gensler at the joint meetings of the Group for Research and Assessment of Psoriasis and Psoriatic Arthritis and the Spondyloarthritis Research & Treatment Network appears to be relevant to valvular disease, arrhythmias, and left ventricular dysfunction. Other CV risk factors associated with AS include hypertension, aortic insufficiency, and conduction disorders.

Inconsistencies in studies of CV

The obstacle for drawing conclusions is the lack of consistency in the published studies that relate specifically to AS but are independent of other inflammatory joint diseases, such as rheumatoid arthritis. In a review, Dr. Gensler cited one meta-analysis of 17 studies published in 2011 that did not associate AS with increased CV events (Arthritis Care Res. 2011;63:557-63). Although several studies published subsequently did associate AS with an increased rate of events, there were others that did not.

In an analysis that was performed at her institution based on AS patient data from the Healthcare Cost and Utilization Project National Inpatient Sample, no difference could be found in in-hospital mortality due to CV events when AS patients were compared with non-AS patients stratified by age.

In regard to CV structural disease related to AS, there is substantial evidence that several abnormalities are more common in AS, but there is far less to document that these lead to an increased risk of events. For example, Dr. Gensler cited one study in which the prevalence of aortic insufficiency climbed from 2% in patients with 10 years’ AS duration to 12% in those with 30 years. In another, inflammation of the septum, a potential risk for conduction disorders, climbed from 3% to 90% in AS patients followed long-term.

Asymptomatic conduction disorders

Conduction disorders in general – and QRS disturbances in particular – have been commonly reported in AS patients, but typically in the absence of symptoms, according to Dr. Gensler. She cited one electrocardiogram study in which 30% of AS patients had QRS prolongation, but all were asymptomatic. In another study of 200 AS patients, conduction disorders were found in 33%, of which atrioventricular block was the most common. In this study, increased markers of inflammation did not correlate with conduction disorders in a multivariate analysis.

"Whether we should be doing anything to look for these [conduction disorders] when they do not have symptoms is a question that I will put out to the audience," Dr. Gensler said.

Effect of treatment on CV events

The effect of AS therapies, particularly tumor necrosis factor (TNF) inhibitors, on CV risk also remains incompletely understood. In one study cited by Dr. Gensler, improved endothelial function was observed in AS patients treated with a TNF inhibitor, suggesting a potential protective effect, but, again, no difference in event rates in AS patients has ever been documented between those on TNF inhibitors and those not on TNF inhibitors.

Overall, more data are needed to determine the effect of AS on the risk of CV events, but one risk factor deserves attention even if there is no specific evidence that it affects CV events, according to Dr. Gensler.

In AS, "we know that smoking is a risk for early-onset disease, more inflammation, more damage, and more progression, so I think this [smoking cessation] is one guideline we can take to heart and take home to our patients," she said.

Dr. Gensler reported financial relationships with UCB and AbbVie.

NEW YORK – Consistent evidence for a substantial increase in cardiovascular events remains elusive for patients with ankylosing spondylitis who have a broad range of CV risk factors.

"We can all agree that the risk factors for cardiovascular disease are higher in patients with AS [ankylosing spondylitis], but I think it is more controversial whether every AS patient faces a higher risk of events," observed Dr. Lianne Gensler, director of the ankylosing spondylitis clinic at the University of California, San Francisco.

Although this statement was made in reference to ischemic heart disease, the analysis presented by Dr. Gensler at the joint meetings of the Group for Research and Assessment of Psoriasis and Psoriatic Arthritis and the Spondyloarthritis Research & Treatment Network appears to be relevant to valvular disease, arrhythmias, and left ventricular dysfunction. Other CV risk factors associated with AS include hypertension, aortic insufficiency, and conduction disorders.

Inconsistencies in studies of CV

The obstacle for drawing conclusions is the lack of consistency in the published studies that relate specifically to AS but are independent of other inflammatory joint diseases, such as rheumatoid arthritis. In a review, Dr. Gensler cited one meta-analysis of 17 studies published in 2011 that did not associate AS with increased CV events (Arthritis Care Res. 2011;63:557-63). Although several studies published subsequently did associate AS with an increased rate of events, there were others that did not.

In an analysis that was performed at her institution based on AS patient data from the Healthcare Cost and Utilization Project National Inpatient Sample, no difference could be found in in-hospital mortality due to CV events when AS patients were compared with non-AS patients stratified by age.

In regard to CV structural disease related to AS, there is substantial evidence that several abnormalities are more common in AS, but there is far less to document that these lead to an increased risk of events. For example, Dr. Gensler cited one study in which the prevalence of aortic insufficiency climbed from 2% in patients with 10 years’ AS duration to 12% in those with 30 years. In another, inflammation of the septum, a potential risk for conduction disorders, climbed from 3% to 90% in AS patients followed long-term.

Asymptomatic conduction disorders

Conduction disorders in general – and QRS disturbances in particular – have been commonly reported in AS patients, but typically in the absence of symptoms, according to Dr. Gensler. She cited one electrocardiogram study in which 30% of AS patients had QRS prolongation, but all were asymptomatic. In another study of 200 AS patients, conduction disorders were found in 33%, of which atrioventricular block was the most common. In this study, increased markers of inflammation did not correlate with conduction disorders in a multivariate analysis.

"Whether we should be doing anything to look for these [conduction disorders] when they do not have symptoms is a question that I will put out to the audience," Dr. Gensler said.

Effect of treatment on CV events

The effect of AS therapies, particularly tumor necrosis factor (TNF) inhibitors, on CV risk also remains incompletely understood. In one study cited by Dr. Gensler, improved endothelial function was observed in AS patients treated with a TNF inhibitor, suggesting a potential protective effect, but, again, no difference in event rates in AS patients has ever been documented between those on TNF inhibitors and those not on TNF inhibitors.

Overall, more data are needed to determine the effect of AS on the risk of CV events, but one risk factor deserves attention even if there is no specific evidence that it affects CV events, according to Dr. Gensler.

In AS, "we know that smoking is a risk for early-onset disease, more inflammation, more damage, and more progression, so I think this [smoking cessation] is one guideline we can take to heart and take home to our patients," she said.

Dr. Gensler reported financial relationships with UCB and AbbVie.