Psoriatic Arthritis ICYMI

Reducing the dose of tumor necrosis factor inhibitors by approximately one-third did not increase disease activity in adults with psoriatic arthritis (PsA) or axial spondyloarthritis (axSpA) in a stable low–disease activity state, according to findings from two parallel controlled retrospective cohort studies.

Disease activity–guided dose optimization (DAGDO) can reduce drug exposure in patients with PsA or axSpA who have low disease activity, but its impact on increased disease activity has not been as well studied as full-dose continuation, Celia A.J. Michielsens, MD, of Sint Maartenskliniek, Nijmegen, the Netherlands, and colleagues wrote.

“DAGDO or discontinuation of bDMARDs [biologic disease-modifying antirheumatic drugs] as a standard of care in adults with stable axSpA is currently discouraged by” the American College of Rheumatology, the researchers said. However, guidelines from the European Alliance of Associations for Rheumatology allow for the slow tapering of bDMARDs in patients with sustained remission.

In a controlled, retrospective cohort study published in Rheumatology, the researchers analyzed data from their outpatient clinic, which initiated a specific TNF inhibitor DAGDO protocol in 2010 for patients with RA, PsA, and axSpA. Disease activity was measured using the Disease Activity Score in 28 joints with C-reactive protein (DAS28-CRP) for patients with PsA and the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) for patients with axSpA.

The study population included 153 patients with PsA who had a mean DAS28-CRP of 6.5 and 171 with axSpA who had a similar mean number of disease activity measurements (6.5 with DAS28-CRP and 6.4 with BASDAI). Median follow-up time was several months short of 4 years in each group. Treatment was divided into three periods: continuation of full TNF inhibitor dose, TNF inhibitor DAGDO, and a period with stable TNF inhibitor dose after DAGDO.

Overall, no significant differences appeared in mean DAS28-CRP and BASDAI over the course of the study between the period of the full TNF inhibitor dose continuation and both the TNF inhibitor DAGDO period and the stable TNF inhibitor dose period. Among PsA patients, the mean DAS28-CRP was 1.94 for the full-dose period, 2.0 in the TNF inhibitor DAGDO period, and 1.97 in the stable TNF inhibitor dose after DAGDO period. For axSpA patients, the mean BASDAI was 3.44, 3.47, and 3.48, respectively, for the three periods. Older age, longer disease duration, and longer follow-up were significantly associated with higher DAS28-CRP scores in patients with PsA, and older age and female gender were significantly associated with higher BASDAI scores in patients with axSpA.

The mean percentage of daily defined dose (%DDD) for patients with PsA was 108% during the full dose period, 62% in the TNF inhibitor DAGDO period, and 78% with stable TNF inhibitor after DAGDO, and nearly the same for patients with axSPA at 108%, 62%, and 72%, respectively.

The %DDD represents “a modest degree of tapering,” compared with studies in RA patients, the researchers noted. “Explanations for this difference could be that the full dose-reduction potential was not met due to suboptimal execution of the local protocol, whereas in prospective intervention trials, protocol adherence is likely higher.”

The study findings were limited by several factors including the open-label design and potential for nocebo effects, possible incorrect attribution, and information bias, as well as the use of DAS28-CRP and BASDAI rather than more modern measurement tools, the researchers noted.

However, the results were strengthened by the large sample size and real-world clinical setting, frequent assessment of disease activity, long-term follow-up, and the performance of DAGDO by rheumatologists familiar with the measuring tools, they said. The results suggest that DAGDO is safe and effective for patients with low disease activity in either condition, but randomized, prospective studies can provide more definitive evidence.

The study received no outside funding. One author disclosed relationships with multiple pharmaceutical companies.

Reducing the dose of tumor necrosis factor inhibitors by approximately one-third did not increase disease activity in adults with psoriatic arthritis (PsA) or axial spondyloarthritis (axSpA) in a stable low–disease activity state, according to findings from two parallel controlled retrospective cohort studies.

Disease activity–guided dose optimization (DAGDO) can reduce drug exposure in patients with PsA or axSpA who have low disease activity, but its impact on increased disease activity has not been as well studied as full-dose continuation, Celia A.J. Michielsens, MD, of Sint Maartenskliniek, Nijmegen, the Netherlands, and colleagues wrote.

“DAGDO or discontinuation of bDMARDs [biologic disease-modifying antirheumatic drugs] as a standard of care in adults with stable axSpA is currently discouraged by” the American College of Rheumatology, the researchers said. However, guidelines from the European Alliance of Associations for Rheumatology allow for the slow tapering of bDMARDs in patients with sustained remission.

In a controlled, retrospective cohort study published in Rheumatology, the researchers analyzed data from their outpatient clinic, which initiated a specific TNF inhibitor DAGDO protocol in 2010 for patients with RA, PsA, and axSpA. Disease activity was measured using the Disease Activity Score in 28 joints with C-reactive protein (DAS28-CRP) for patients with PsA and the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) for patients with axSpA.

The study population included 153 patients with PsA who had a mean DAS28-CRP of 6.5 and 171 with axSpA who had a similar mean number of disease activity measurements (6.5 with DAS28-CRP and 6.4 with BASDAI). Median follow-up time was several months short of 4 years in each group. Treatment was divided into three periods: continuation of full TNF inhibitor dose, TNF inhibitor DAGDO, and a period with stable TNF inhibitor dose after DAGDO.

Overall, no significant differences appeared in mean DAS28-CRP and BASDAI over the course of the study between the period of the full TNF inhibitor dose continuation and both the TNF inhibitor DAGDO period and the stable TNF inhibitor dose period. Among PsA patients, the mean DAS28-CRP was 1.94 for the full-dose period, 2.0 in the TNF inhibitor DAGDO period, and 1.97 in the stable TNF inhibitor dose after DAGDO period. For axSpA patients, the mean BASDAI was 3.44, 3.47, and 3.48, respectively, for the three periods. Older age, longer disease duration, and longer follow-up were significantly associated with higher DAS28-CRP scores in patients with PsA, and older age and female gender were significantly associated with higher BASDAI scores in patients with axSpA.

The mean percentage of daily defined dose (%DDD) for patients with PsA was 108% during the full dose period, 62% in the TNF inhibitor DAGDO period, and 78% with stable TNF inhibitor after DAGDO, and nearly the same for patients with axSPA at 108%, 62%, and 72%, respectively.

The %DDD represents “a modest degree of tapering,” compared with studies in RA patients, the researchers noted. “Explanations for this difference could be that the full dose-reduction potential was not met due to suboptimal execution of the local protocol, whereas in prospective intervention trials, protocol adherence is likely higher.”

The study findings were limited by several factors including the open-label design and potential for nocebo effects, possible incorrect attribution, and information bias, as well as the use of DAS28-CRP and BASDAI rather than more modern measurement tools, the researchers noted.

However, the results were strengthened by the large sample size and real-world clinical setting, frequent assessment of disease activity, long-term follow-up, and the performance of DAGDO by rheumatologists familiar with the measuring tools, they said. The results suggest that DAGDO is safe and effective for patients with low disease activity in either condition, but randomized, prospective studies can provide more definitive evidence.

The study received no outside funding. One author disclosed relationships with multiple pharmaceutical companies.

Reducing the dose of tumor necrosis factor inhibitors by approximately one-third did not increase disease activity in adults with psoriatic arthritis (PsA) or axial spondyloarthritis (axSpA) in a stable low–disease activity state, according to findings from two parallel controlled retrospective cohort studies.

Disease activity–guided dose optimization (DAGDO) can reduce drug exposure in patients with PsA or axSpA who have low disease activity, but its impact on increased disease activity has not been as well studied as full-dose continuation, Celia A.J. Michielsens, MD, of Sint Maartenskliniek, Nijmegen, the Netherlands, and colleagues wrote.

“DAGDO or discontinuation of bDMARDs [biologic disease-modifying antirheumatic drugs] as a standard of care in adults with stable axSpA is currently discouraged by” the American College of Rheumatology, the researchers said. However, guidelines from the European Alliance of Associations for Rheumatology allow for the slow tapering of bDMARDs in patients with sustained remission.

In a controlled, retrospective cohort study published in Rheumatology, the researchers analyzed data from their outpatient clinic, which initiated a specific TNF inhibitor DAGDO protocol in 2010 for patients with RA, PsA, and axSpA. Disease activity was measured using the Disease Activity Score in 28 joints with C-reactive protein (DAS28-CRP) for patients with PsA and the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) for patients with axSpA.

The study population included 153 patients with PsA who had a mean DAS28-CRP of 6.5 and 171 with axSpA who had a similar mean number of disease activity measurements (6.5 with DAS28-CRP and 6.4 with BASDAI). Median follow-up time was several months short of 4 years in each group. Treatment was divided into three periods: continuation of full TNF inhibitor dose, TNF inhibitor DAGDO, and a period with stable TNF inhibitor dose after DAGDO.

Overall, no significant differences appeared in mean DAS28-CRP and BASDAI over the course of the study between the period of the full TNF inhibitor dose continuation and both the TNF inhibitor DAGDO period and the stable TNF inhibitor dose period. Among PsA patients, the mean DAS28-CRP was 1.94 for the full-dose period, 2.0 in the TNF inhibitor DAGDO period, and 1.97 in the stable TNF inhibitor dose after DAGDO period. For axSpA patients, the mean BASDAI was 3.44, 3.47, and 3.48, respectively, for the three periods. Older age, longer disease duration, and longer follow-up were significantly associated with higher DAS28-CRP scores in patients with PsA, and older age and female gender were significantly associated with higher BASDAI scores in patients with axSpA.

The mean percentage of daily defined dose (%DDD) for patients with PsA was 108% during the full dose period, 62% in the TNF inhibitor DAGDO period, and 78% with stable TNF inhibitor after DAGDO, and nearly the same for patients with axSPA at 108%, 62%, and 72%, respectively.

The %DDD represents “a modest degree of tapering,” compared with studies in RA patients, the researchers noted. “Explanations for this difference could be that the full dose-reduction potential was not met due to suboptimal execution of the local protocol, whereas in prospective intervention trials, protocol adherence is likely higher.”

The study findings were limited by several factors including the open-label design and potential for nocebo effects, possible incorrect attribution, and information bias, as well as the use of DAS28-CRP and BASDAI rather than more modern measurement tools, the researchers noted.

However, the results were strengthened by the large sample size and real-world clinical setting, frequent assessment of disease activity, long-term follow-up, and the performance of DAGDO by rheumatologists familiar with the measuring tools, they said. The results suggest that DAGDO is safe and effective for patients with low disease activity in either condition, but randomized, prospective studies can provide more definitive evidence.

The study received no outside funding. One author disclosed relationships with multiple pharmaceutical companies.

Patients with psoriatic arthritis (PsA) showed more improvement in symptoms at 6 months with risankizumab (Skyrizi) than with placebo in combined phase 3, randomized, controlled trials, according to data presented at the virtual annual meeting of the American College of Rheumatology.

“Risankizumab was well tolerated and showed no new safety signals over those seen in the trial program for psoriasis,” reported Andrew Östör, MD, of Monash University and Cabrini Hospital, both in Melbourne. The results included pooled data that added KEEPsAKE 1 data to KEEPsAKE 2 results, which were presented at the 2021 congress of the European Alliance of Associations for Rheumatology.

Risankizumab received Food and Drug Administration approval in 2019 for moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy. The humanized monoclonal antibody inhibits interleukin-23, which is believed to be involved in the development of PsA. The FDA updated its approval in August 2021 to make it available as a 150-mg single-dose injection instead of two 75-mg doses for psoriasis treatment, but it is not yet approved for PsA.

The trials included adults with active PsA, active plaque psoriasis or nail psoriasis, and at least five swollen joints and five tender joints. All the participants had an inadequate response or intolerance to at least one conventional synthetic disease-modifying antirheumatic drug (csDMARD), and KEEPsAKE 2 included participants who had an inadequate response or intolerance to at least one biologic therapy.

The majority of patients in both groups were taking anti-inflammatory drugs (58.8% with risankizumab vs. 62.1% with placebo) and methotrexate (60% vs. 59.1%, respectively), but a minority were taking oral glucocorticoids (18.2% with risankizumab vs. 15.6% with placebo). A small proportion in both groups were also taking a csDMARD besides methotrexate (11.9% with risankizumab vs. 11.3% with placebo).

Participants were randomly assigned to receive either 150 mg of subcutaneous risankizumab or placebo at baseline, 4 weeks, and 16 weeks with a double-blind protocol. The proportion of patients with 20% improvement in ACR response criteria (ACR 20) at 24 weeks was the primary endpoint. The trial is currently continuing with all participants receiving open-label risankizumab.

The 1,407 patients initially enrolled included 707 receiving risankizumab and 700 receiving placebo across both trials, with similar baseline demographic and disease characteristics in both groups. A total of 1,354 participants completed the 24-week assessments, including 688 receiving risankizumab and 666 receiving placebo. In an intent-to-treat analysis, 55.5% of patients receiving risankizumab and 31.3% of those receiving placebo achieved ACR 20 at week 24 (P < .001). Participants who received risankizumab also had more improvement in secondary clinical and patient-reported outcomes than did those who received placebo. A quarter (25.2%) of risankizumab patients versus 10.6% of placebo patients showed minimal disease activity, and significantly more participants receiving risankizumab than placebo saw resolution of enthesitis, dactylitis, and fatigue.

Adverse events of any kind occurred in 45.5% of risankizumab and 43.9% of placebo participants, with similar numbers of serious adverse events (3% vs. 4.4%, respectively). One death caused by urosepsis in an 81-year-old participant with dementia occurred in the risankizumab group and was determined to be unrelated to the drug.

David Karp, MD, PhD, chief of division of rheumatic diseases at the University of Texas Southwestern Medical Center in Dallas and ACR president, conducted a question-and-answer session with Dr. Östör following his presentation and asked whether a difference in responses was seen between patients who had failed biologic DMARDs. Dr. Östör said the response rates were similar independent of which previous therapies the participants had failed.

Regarding where risankizumab, as an IL-23 inhibitor, fits among the options for treating PsA, Dr. Östör said “the data speaks for itself” in terms of efficacy with arthritic, musculoskeletal manifestations and the patient-reported outcomes.

“One of the major benefits of these medications is their remarkable effect on skin with psoriasis,” Dr. Östör told Dr. Karp. Regarding axial response to the drug, Dr. Östör noted the statistically significant improvement in Bath Ankylosing Spondylitis Disease Activity Index, appearing to show a clinical benefit with spinal inflammatory disease. Radiologic data, however, are not currently available for the trials.

Dr. Karp noted the recent findings of a phase 2a trial published in the New England Journal of Medicine regarding risankizumab’s poor performance in patients with severe asthma, who experienced worsening symptoms sooner and more rapidly than did those who received placebo. It’s unclear whether any patients in the KEEPsAKE 1 or 2 trials had an asthma diagnosis, but any people with unstable, severe asthma would have been excluded from participation, Dr. Östör said.

The research was funded by AbbVie. Dr. Östör and colleagues have a range of financial ties to numerous pharmaceutical companies.

Patients with psoriatic arthritis (PsA) showed more improvement in symptoms at 6 months with risankizumab (Skyrizi) than with placebo in combined phase 3, randomized, controlled trials, according to data presented at the virtual annual meeting of the American College of Rheumatology.

“Risankizumab was well tolerated and showed no new safety signals over those seen in the trial program for psoriasis,” reported Andrew Östör, MD, of Monash University and Cabrini Hospital, both in Melbourne. The results included pooled data that added KEEPsAKE 1 data to KEEPsAKE 2 results, which were presented at the 2021 congress of the European Alliance of Associations for Rheumatology.

Risankizumab received Food and Drug Administration approval in 2019 for moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy. The humanized monoclonal antibody inhibits interleukin-23, which is believed to be involved in the development of PsA. The FDA updated its approval in August 2021 to make it available as a 150-mg single-dose injection instead of two 75-mg doses for psoriasis treatment, but it is not yet approved for PsA.

The trials included adults with active PsA, active plaque psoriasis or nail psoriasis, and at least five swollen joints and five tender joints. All the participants had an inadequate response or intolerance to at least one conventional synthetic disease-modifying antirheumatic drug (csDMARD), and KEEPsAKE 2 included participants who had an inadequate response or intolerance to at least one biologic therapy.

The majority of patients in both groups were taking anti-inflammatory drugs (58.8% with risankizumab vs. 62.1% with placebo) and methotrexate (60% vs. 59.1%, respectively), but a minority were taking oral glucocorticoids (18.2% with risankizumab vs. 15.6% with placebo). A small proportion in both groups were also taking a csDMARD besides methotrexate (11.9% with risankizumab vs. 11.3% with placebo).

Participants were randomly assigned to receive either 150 mg of subcutaneous risankizumab or placebo at baseline, 4 weeks, and 16 weeks with a double-blind protocol. The proportion of patients with 20% improvement in ACR response criteria (ACR 20) at 24 weeks was the primary endpoint. The trial is currently continuing with all participants receiving open-label risankizumab.

The 1,407 patients initially enrolled included 707 receiving risankizumab and 700 receiving placebo across both trials, with similar baseline demographic and disease characteristics in both groups. A total of 1,354 participants completed the 24-week assessments, including 688 receiving risankizumab and 666 receiving placebo. In an intent-to-treat analysis, 55.5% of patients receiving risankizumab and 31.3% of those receiving placebo achieved ACR 20 at week 24 (P < .001). Participants who received risankizumab also had more improvement in secondary clinical and patient-reported outcomes than did those who received placebo. A quarter (25.2%) of risankizumab patients versus 10.6% of placebo patients showed minimal disease activity, and significantly more participants receiving risankizumab than placebo saw resolution of enthesitis, dactylitis, and fatigue.

Adverse events of any kind occurred in 45.5% of risankizumab and 43.9% of placebo participants, with similar numbers of serious adverse events (3% vs. 4.4%, respectively). One death caused by urosepsis in an 81-year-old participant with dementia occurred in the risankizumab group and was determined to be unrelated to the drug.

David Karp, MD, PhD, chief of division of rheumatic diseases at the University of Texas Southwestern Medical Center in Dallas and ACR president, conducted a question-and-answer session with Dr. Östör following his presentation and asked whether a difference in responses was seen between patients who had failed biologic DMARDs. Dr. Östör said the response rates were similar independent of which previous therapies the participants had failed.

Regarding where risankizumab, as an IL-23 inhibitor, fits among the options for treating PsA, Dr. Östör said “the data speaks for itself” in terms of efficacy with arthritic, musculoskeletal manifestations and the patient-reported outcomes.

“One of the major benefits of these medications is their remarkable effect on skin with psoriasis,” Dr. Östör told Dr. Karp. Regarding axial response to the drug, Dr. Östör noted the statistically significant improvement in Bath Ankylosing Spondylitis Disease Activity Index, appearing to show a clinical benefit with spinal inflammatory disease. Radiologic data, however, are not currently available for the trials.

Dr. Karp noted the recent findings of a phase 2a trial published in the New England Journal of Medicine regarding risankizumab’s poor performance in patients with severe asthma, who experienced worsening symptoms sooner and more rapidly than did those who received placebo. It’s unclear whether any patients in the KEEPsAKE 1 or 2 trials had an asthma diagnosis, but any people with unstable, severe asthma would have been excluded from participation, Dr. Östör said.

The research was funded by AbbVie. Dr. Östör and colleagues have a range of financial ties to numerous pharmaceutical companies.

Patients with psoriatic arthritis (PsA) showed more improvement in symptoms at 6 months with risankizumab (Skyrizi) than with placebo in combined phase 3, randomized, controlled trials, according to data presented at the virtual annual meeting of the American College of Rheumatology.

“Risankizumab was well tolerated and showed no new safety signals over those seen in the trial program for psoriasis,” reported Andrew Östör, MD, of Monash University and Cabrini Hospital, both in Melbourne. The results included pooled data that added KEEPsAKE 1 data to KEEPsAKE 2 results, which were presented at the 2021 congress of the European Alliance of Associations for Rheumatology.

Risankizumab received Food and Drug Administration approval in 2019 for moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy. The humanized monoclonal antibody inhibits interleukin-23, which is believed to be involved in the development of PsA. The FDA updated its approval in August 2021 to make it available as a 150-mg single-dose injection instead of two 75-mg doses for psoriasis treatment, but it is not yet approved for PsA.

The trials included adults with active PsA, active plaque psoriasis or nail psoriasis, and at least five swollen joints and five tender joints. All the participants had an inadequate response or intolerance to at least one conventional synthetic disease-modifying antirheumatic drug (csDMARD), and KEEPsAKE 2 included participants who had an inadequate response or intolerance to at least one biologic therapy.

The majority of patients in both groups were taking anti-inflammatory drugs (58.8% with risankizumab vs. 62.1% with placebo) and methotrexate (60% vs. 59.1%, respectively), but a minority were taking oral glucocorticoids (18.2% with risankizumab vs. 15.6% with placebo). A small proportion in both groups were also taking a csDMARD besides methotrexate (11.9% with risankizumab vs. 11.3% with placebo).

Participants were randomly assigned to receive either 150 mg of subcutaneous risankizumab or placebo at baseline, 4 weeks, and 16 weeks with a double-blind protocol. The proportion of patients with 20% improvement in ACR response criteria (ACR 20) at 24 weeks was the primary endpoint. The trial is currently continuing with all participants receiving open-label risankizumab.

The 1,407 patients initially enrolled included 707 receiving risankizumab and 700 receiving placebo across both trials, with similar baseline demographic and disease characteristics in both groups. A total of 1,354 participants completed the 24-week assessments, including 688 receiving risankizumab and 666 receiving placebo. In an intent-to-treat analysis, 55.5% of patients receiving risankizumab and 31.3% of those receiving placebo achieved ACR 20 at week 24 (P < .001). Participants who received risankizumab also had more improvement in secondary clinical and patient-reported outcomes than did those who received placebo. A quarter (25.2%) of risankizumab patients versus 10.6% of placebo patients showed minimal disease activity, and significantly more participants receiving risankizumab than placebo saw resolution of enthesitis, dactylitis, and fatigue.

Adverse events of any kind occurred in 45.5% of risankizumab and 43.9% of placebo participants, with similar numbers of serious adverse events (3% vs. 4.4%, respectively). One death caused by urosepsis in an 81-year-old participant with dementia occurred in the risankizumab group and was determined to be unrelated to the drug.

David Karp, MD, PhD, chief of division of rheumatic diseases at the University of Texas Southwestern Medical Center in Dallas and ACR president, conducted a question-and-answer session with Dr. Östör following his presentation and asked whether a difference in responses was seen between patients who had failed biologic DMARDs. Dr. Östör said the response rates were similar independent of which previous therapies the participants had failed.

Regarding where risankizumab, as an IL-23 inhibitor, fits among the options for treating PsA, Dr. Östör said “the data speaks for itself” in terms of efficacy with arthritic, musculoskeletal manifestations and the patient-reported outcomes.

“One of the major benefits of these medications is their remarkable effect on skin with psoriasis,” Dr. Östör told Dr. Karp. Regarding axial response to the drug, Dr. Östör noted the statistically significant improvement in Bath Ankylosing Spondylitis Disease Activity Index, appearing to show a clinical benefit with spinal inflammatory disease. Radiologic data, however, are not currently available for the trials.

Dr. Karp noted the recent findings of a phase 2a trial published in the New England Journal of Medicine regarding risankizumab’s poor performance in patients with severe asthma, who experienced worsening symptoms sooner and more rapidly than did those who received placebo. It’s unclear whether any patients in the KEEPsAKE 1 or 2 trials had an asthma diagnosis, but any people with unstable, severe asthma would have been excluded from participation, Dr. Östör said.

The research was funded by AbbVie. Dr. Östör and colleagues have a range of financial ties to numerous pharmaceutical companies.

There have been quite a few papers published in October that have provided further insights into psoriatic arthritis (PsA). Understanding risk factors for developing PsA in patients with psoriasis is of ongoing interest, but there is limited data on the relationship between the severity of psoriasis and the risk of developing PsA especially in the USA population. Using the Optum electronic health records (EHR) database, Merola et al¹ assessed the incidence, prevalence, and predictors of PsA among 114,868 patients with psoriasis between January 1, 2009, and March 31, 2019. The severity of psoriasis was determined by treatment received during the 1 year after psoriasis diagnosis as follows: mild (89.3%) topicals and phototherapy only; moderate (5.5%) nonbiologic systemic therapies (acitretin, apremilast, cyclosporine, methotrexate), and severe (5.2%) biologic therapies (adalimumab, certolizumab pegol, etanercept, golimumab, guselkumab, infliximab, ixekizumab, secukinumab, ustekinumab). They found that the overall incidence of PsA was 2.9 (95% CI 2.9-3.0) events per 100 patient-years of follow up (PY). The incidence (100 PY, 95% CI) by severity was lowest (2.1 [95% CI 2.1-2.1]) in the mild, higher in the moderate (9.9 [95% CI 9.5-10.4]), and highest (17.6 [95% CI 16.9-18.3]) in the severe psoriasis category. The study thus confirms that patients with more severe psoriasis have higher risk of developing PsA.

The effect of treatment of psoriasis on the development of PsA is also have great interest. Recent studies² have indicated that biologic treatment of psoriasis may reduce the incidence of PsA. However, Meer et al³ in a retrospective cohort study using of 1,93,709 patients with psoriasis without PsA in the Optum Insights EHR database report that biologic use was associated with the development of PsA among patients with psoriasis. After propensity score matching, the hazard ratio was 2.14 (95% CI 2.00-2.28) for patients on biologics compared to those on oral therapy or phototherapy. Such studies are influenced by confounding factors ,by indication, and protopathic bias and hence prospective studies are warranted.

Better treatment outcomes are likely if patient priorities are taken into account when choosing a therapy. However, there are few studies addressing this issue. Sumpton et al⁴ conducted a discrete choice experiment in patients with PsA in Sydney, Australia, to assess preferences for different attributes of biologics. They identified the following attributes in order of preference: oral route (compared to subcutaneous and intravenous routes), avoiding severe side effects, increasing ability to attend to normal activities, avoiding infections, improvement in enthesitis pain, improvement in psoriasis, increasing chance of remission and improvement in joint pain. Thus, patients valued ease of administration, avoiding side effects, and physical function more when choosing a therapy. With increased availability of treatment choices, developing decision support systems that facilitate shared decision making between patients and clinicians is required to improve care of PsA patients.

Ultrasound is increasingly being used at the point of care in rheumatology, but until now ultrasound was not used as a primary outcome in a clinical trial. In the first randomized, placebo-controlled, phase III study using power Doppler ultrasound (PDUS) D’Agostino et al⁵ demonstrated that treatment with secukinumab (dosed according to psoriasis severity) led to statistically significant improvement in synovitis measured using the Global European League Against Rheumatism and Outcome Measures in Rheumatoid Arthritis Clinical Trials Synovitis Score (GLOESS) compared to placebo. Thus, secukinumab, an IL-17A inhibitor, reduces synovitis as detected by ultrasound as well as symptoms and clinical signs of PsA.

References

1. Merola JF et al. Incidence and Prevalence of Psoriatic Arthritis in Patients With Psoriasis Stratified by Psoriasis Disease Severity: Retrospective Analysis of a US Electronic Health Records Database. J Am Acad Dermatol. 2021(Sep 18):S0190-9622(21)02494-4.
2. Acosta Felquer ML et al. Treating the skin with biologics in patients with psoriasis decreases the incidence of psoriatic arthritis. Ann Rheum Dis. 2021 (Jul 19):annrheumdis-2021-220865.
3. Meer E et al. Does biologic therapy impact the development of PsA among patients with psoriasis? Ann Rheum Dis. 2021(Oct 6):annrheumdis-2021-220761.
4. Sumpton D et al. Preferences for biologic treatment in patients with psoriatic arthritis: a discrete choice experiment. Arthritis Care Res (Hoboken). 2021(Sep 13):acr.24782
5. D'Agostino MA et al. Response to secukinumab on synovitis using power Doppler ultrasound in psoriatic arthritis: 12-week results from a phase III study, ULTIMATE. Rheumatology (Oxford). 2021(Sep 16):keab628.

There have been quite a few papers published in October that have provided further insights into psoriatic arthritis (PsA). Understanding risk factors for developing PsA in patients with psoriasis is of ongoing interest, but there is limited data on the relationship between the severity of psoriasis and the risk of developing PsA especially in the USA population. Using the Optum electronic health records (EHR) database, Merola et al¹ assessed the incidence, prevalence, and predictors of PsA among 114,868 patients with psoriasis between January 1, 2009, and March 31, 2019. The severity of psoriasis was determined by treatment received during the 1 year after psoriasis diagnosis as follows: mild (89.3%) topicals and phototherapy only; moderate (5.5%) nonbiologic systemic therapies (acitretin, apremilast, cyclosporine, methotrexate), and severe (5.2%) biologic therapies (adalimumab, certolizumab pegol, etanercept, golimumab, guselkumab, infliximab, ixekizumab, secukinumab, ustekinumab). They found that the overall incidence of PsA was 2.9 (95% CI 2.9-3.0) events per 100 patient-years of follow up (PY). The incidence (100 PY, 95% CI) by severity was lowest (2.1 [95% CI 2.1-2.1]) in the mild, higher in the moderate (9.9 [95% CI 9.5-10.4]), and highest (17.6 [95% CI 16.9-18.3]) in the severe psoriasis category. The study thus confirms that patients with more severe psoriasis have higher risk of developing PsA.

The effect of treatment of psoriasis on the development of PsA is also have great interest. Recent studies² have indicated that biologic treatment of psoriasis may reduce the incidence of PsA. However, Meer et al³ in a retrospective cohort study using of 1,93,709 patients with psoriasis without PsA in the Optum Insights EHR database report that biologic use was associated with the development of PsA among patients with psoriasis. After propensity score matching, the hazard ratio was 2.14 (95% CI 2.00-2.28) for patients on biologics compared to those on oral therapy or phototherapy. Such studies are influenced by confounding factors ,by indication, and protopathic bias and hence prospective studies are warranted.

Better treatment outcomes are likely if patient priorities are taken into account when choosing a therapy. However, there are few studies addressing this issue. Sumpton et al⁴ conducted a discrete choice experiment in patients with PsA in Sydney, Australia, to assess preferences for different attributes of biologics. They identified the following attributes in order of preference: oral route (compared to subcutaneous and intravenous routes), avoiding severe side effects, increasing ability to attend to normal activities, avoiding infections, improvement in enthesitis pain, improvement in psoriasis, increasing chance of remission and improvement in joint pain. Thus, patients valued ease of administration, avoiding side effects, and physical function more when choosing a therapy. With increased availability of treatment choices, developing decision support systems that facilitate shared decision making between patients and clinicians is required to improve care of PsA patients.

Ultrasound is increasingly being used at the point of care in rheumatology, but until now ultrasound was not used as a primary outcome in a clinical trial. In the first randomized, placebo-controlled, phase III study using power Doppler ultrasound (PDUS) D’Agostino et al⁵ demonstrated that treatment with secukinumab (dosed according to psoriasis severity) led to statistically significant improvement in synovitis measured using the Global European League Against Rheumatism and Outcome Measures in Rheumatoid Arthritis Clinical Trials Synovitis Score (GLOESS) compared to placebo. Thus, secukinumab, an IL-17A inhibitor, reduces synovitis as detected by ultrasound as well as symptoms and clinical signs of PsA.

References

1. Merola JF et al. Incidence and Prevalence of Psoriatic Arthritis in Patients With Psoriasis Stratified by Psoriasis Disease Severity: Retrospective Analysis of a US Electronic Health Records Database. J Am Acad Dermatol. 2021(Sep 18):S0190-9622(21)02494-4.
2. Acosta Felquer ML et al. Treating the skin with biologics in patients with psoriasis decreases the incidence of psoriatic arthritis. Ann Rheum Dis. 2021 (Jul 19):annrheumdis-2021-220865.
3. Meer E et al. Does biologic therapy impact the development of PsA among patients with psoriasis? Ann Rheum Dis. 2021(Oct 6):annrheumdis-2021-220761.
4. Sumpton D et al. Preferences for biologic treatment in patients with psoriatic arthritis: a discrete choice experiment. Arthritis Care Res (Hoboken). 2021(Sep 13):acr.24782
5. D'Agostino MA et al. Response to secukinumab on synovitis using power Doppler ultrasound in psoriatic arthritis: 12-week results from a phase III study, ULTIMATE. Rheumatology (Oxford). 2021(Sep 16):keab628.

There have been quite a few papers published in October that have provided further insights into psoriatic arthritis (PsA). Understanding risk factors for developing PsA in patients with psoriasis is of ongoing interest, but there is limited data on the relationship between the severity of psoriasis and the risk of developing PsA especially in the USA population. Using the Optum electronic health records (EHR) database, Merola et al¹ assessed the incidence, prevalence, and predictors of PsA among 114,868 patients with psoriasis between January 1, 2009, and March 31, 2019. The severity of psoriasis was determined by treatment received during the 1 year after psoriasis diagnosis as follows: mild (89.3%) topicals and phototherapy only; moderate (5.5%) nonbiologic systemic therapies (acitretin, apremilast, cyclosporine, methotrexate), and severe (5.2%) biologic therapies (adalimumab, certolizumab pegol, etanercept, golimumab, guselkumab, infliximab, ixekizumab, secukinumab, ustekinumab). They found that the overall incidence of PsA was 2.9 (95% CI 2.9-3.0) events per 100 patient-years of follow up (PY). The incidence (100 PY, 95% CI) by severity was lowest (2.1 [95% CI 2.1-2.1]) in the mild, higher in the moderate (9.9 [95% CI 9.5-10.4]), and highest (17.6 [95% CI 16.9-18.3]) in the severe psoriasis category. The study thus confirms that patients with more severe psoriasis have higher risk of developing PsA.

The effect of treatment of psoriasis on the development of PsA is also have great interest. Recent studies² have indicated that biologic treatment of psoriasis may reduce the incidence of PsA. However, Meer et al³ in a retrospective cohort study using of 1,93,709 patients with psoriasis without PsA in the Optum Insights EHR database report that biologic use was associated with the development of PsA among patients with psoriasis. After propensity score matching, the hazard ratio was 2.14 (95% CI 2.00-2.28) for patients on biologics compared to those on oral therapy or phototherapy. Such studies are influenced by confounding factors ,by indication, and protopathic bias and hence prospective studies are warranted.

Better treatment outcomes are likely if patient priorities are taken into account when choosing a therapy. However, there are few studies addressing this issue. Sumpton et al⁴ conducted a discrete choice experiment in patients with PsA in Sydney, Australia, to assess preferences for different attributes of biologics. They identified the following attributes in order of preference: oral route (compared to subcutaneous and intravenous routes), avoiding severe side effects, increasing ability to attend to normal activities, avoiding infections, improvement in enthesitis pain, improvement in psoriasis, increasing chance of remission and improvement in joint pain. Thus, patients valued ease of administration, avoiding side effects, and physical function more when choosing a therapy. With increased availability of treatment choices, developing decision support systems that facilitate shared decision making between patients and clinicians is required to improve care of PsA patients.

Ultrasound is increasingly being used at the point of care in rheumatology, but until now ultrasound was not used as a primary outcome in a clinical trial. In the first randomized, placebo-controlled, phase III study using power Doppler ultrasound (PDUS) D’Agostino et al⁵ demonstrated that treatment with secukinumab (dosed according to psoriasis severity) led to statistically significant improvement in synovitis measured using the Global European League Against Rheumatism and Outcome Measures in Rheumatoid Arthritis Clinical Trials Synovitis Score (GLOESS) compared to placebo. Thus, secukinumab, an IL-17A inhibitor, reduces synovitis as detected by ultrasound as well as symptoms and clinical signs of PsA.

References

1. Merola JF et al. Incidence and Prevalence of Psoriatic Arthritis in Patients With Psoriasis Stratified by Psoriasis Disease Severity: Retrospective Analysis of a US Electronic Health Records Database. J Am Acad Dermatol. 2021(Sep 18):S0190-9622(21)02494-4.
2. Acosta Felquer ML et al. Treating the skin with biologics in patients with psoriasis decreases the incidence of psoriatic arthritis. Ann Rheum Dis. 2021 (Jul 19):annrheumdis-2021-220865.
3. Meer E et al. Does biologic therapy impact the development of PsA among patients with psoriasis? Ann Rheum Dis. 2021(Oct 6):annrheumdis-2021-220761.
4. Sumpton D et al. Preferences for biologic treatment in patients with psoriatic arthritis: a discrete choice experiment. Arthritis Care Res (Hoboken). 2021(Sep 13):acr.24782
5. D'Agostino MA et al. Response to secukinumab on synovitis using power Doppler ultrasound in psoriatic arthritis: 12-week results from a phase III study, ULTIMATE. Rheumatology (Oxford). 2021(Sep 16):keab628.

Disease-modifying antirheumatic drugs (DMARDs) such as biologics may carry an increased risk for preterm birth or cesarean delivery for pregnant women with psoriatic arthritis (PsA), according to a recent study published in Arthritis & Rheumatology.

zoranm/Getty Images

The risk was particularly high for women with PsA who received biologic disease-modifying antirheumatic drugs (bDMARDs), according to Katarina Remaeus, PhD, of the Karolinska Institute in Stockholm and colleagues.

“The results may indicate that a more severe or active PsA disease that requires antirheumatic treatment during pregnancy, especially bDMARDs, is associated with increased risks of adverse pregnancy outcomes compared to non-PsA pregnancies,” Dr. Remaeus and colleagues write in their study. “The risk of preterm birth in PsA pregnancies is further influenced by parity with the most increased risks observed in first pregnancies.”

In a nationwide, register-based cohort study, the researchers evaluated 921 pregnancies of women with PsA between 2007 and 2017, comparing them to the pregnancies of 9,210 women without PsA over the same time frame. The pregnancies for women with PsA were further categorized based on whether the women had not received antirheumatic treatment in the year prior to and/or during pregnancy (495 pregnancies) or had received antirheumatic treatment at any point in the year before and/or during pregnancy (426 pregnancies).

Of the women in the PsA group who were treated in the year prior to pregnancy (170 women), 39.4% received monotherapy with a conventional synthetic DMARD (csDMARD) such as an antimalarial, methotrexate, or sulfasalazine; 24.1% received oral corticosteroids, and 15.9% received a tumor necrosis factor inhibitor (TNFi), whereas about 20% of women received two or more antirheumatic drugs.

In the group of women treated during pregnancy (256 women), 153 did not receive bDMARDs; of these, 41.8% had monotherapy with either a csDMARD or corticosteroids, whereas the group treated with bDMARDs received TNFi monotherapy (43.7%) or TNFi with corticosteroids (35.9%), TNFi with csDMARD (9.7%), or TNFi with csDMARD plus corticosteroids (9.7%).

A majority of women in both groups (70.1%) were between ages 30 and 34 years (37.1%) or older than age 35 years (33%) and had delivered more than one child (63.2%). Women in the PsA group were more likely to be born in a Nordic country (91.8% vs. 82.8%), to have a body mass index between 30.0 and 60.0 kg/m² (19.9% vs. 12.6%), to be a smoker (9.2% vs. 5.3%), to have hypertension (1.4% vs. 0.8%) or diabetes (1.3% vs. 0.5%) prior to pregnancy, and to have a higher level of education (>12 years; 50.1% vs. 43.3%), compared with women in the non-PsA group.

The results showed women in the PsA group were more likely to experience preterm birth (adjusted odds ratio, 1.69; 95% confidence interval, 1.27-2.24) and undergo an elective (aOR, 1.77; 95% CI, 1.43-2.20) or emergency C-section (aOR, 1.42; 95% CI, 1.10-1.84). The group at highest risk for preterm birth with regard to parity was women with PsA having their first child (aOR, 3.95; 95% CI, 1.43-10.95).

Women who received antirheumatic treatment were at greater risk for experiencing preterm birth (aOR, 2.30; 95% CI, 1.49-3.56), and this risk was even higher for treatment with bDMARDs, compared with women without PsA (aOR, 4.49; 95% CI, 2.60-7.79). Use of bDMARDs also was associated with higher risks for spontaneous preterm birth (aOR, 4.73; 95% CI, 2.53-8.87), preterm birth between 32 and 36 weeks’ gestation (aOR, 5.06; 95% CI, 2.91-8.79), elective C-section (aOR, 2.72; 95% CI, 1.61-4.59), emergency C-section (aOR, 2.06; 95% CI, 1.04-4.07), and preeclampsia (aOR, 2.88, 95% CI, 1.35-6.17).

The researchers note that women with PsA should be evaluated for preterm birth particularly if they are having their first child, and “from a clinical point of view, all women with PsA, regardless of antirheumatic treatment, should be counseled about pregnancy outcomes and receive individualized monitoring during pregnancy.”

Are adverse outcomes linked to disease activity or treatment?

Patients in the study had a higher risk of adverse outcomes when they had a PsA diagnosis, and when they received antirheumatic treatment – but were the adverse outcomes associated with a patient’s high disease activity or need for antirheumatic treatment?

“Our interpretation is that a PsA disease that requires continued antirheumatic treatment during pregnancy is more severe than PsA that does not require treatment,” Dr. Remaeus and colleagues write. “Thus, the increased risk of adverse outcomes in pregnancies with maternal antirheumatic treatment is probably attributed to disease severity rather than an effect of the medication itself.”

Anja Strangfeld, MD, PhD, of the German Rheumatism Research Centre in Berlin, told this news organization that the results of the study are important because it is one of the first to report differences in risk in pregnancy outcomes for women with and without PsA.

“The information is relevant to guide rheumatologists in advising patients with PsA when planning the first or subsequent pregnancies,” she said. “The results are reassuring in reporting that the elevated risk for PsA patients for adverse pregnancy outcomes is low in patients not in need of antirheumatic medication, presumably in low-disease activity.”

However, the study is still unclear on whether the association with adverse pregnancy outcomes in patients is the result of higher disease activity or the need for antirheumatic treatment, she explained.

“It was only hypothesized that those patients under bDMARD treatment are/were in high disease activity. There [is] no information on disease activity in the data sources, which limits the results,” she said. “The investigation still does not solve the important question – if adverse pregnancy outcomes are rather related to high disease activity or the medication to treat this situation.”

There was no specific funding for this study. The study authors and Dr. Strangfeld have disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Disease-modifying antirheumatic drugs (DMARDs) such as biologics may carry an increased risk for preterm birth or cesarean delivery for pregnant women with psoriatic arthritis (PsA), according to a recent study published in Arthritis & Rheumatology.

zoranm/Getty Images

The risk was particularly high for women with PsA who received biologic disease-modifying antirheumatic drugs (bDMARDs), according to Katarina Remaeus, PhD, of the Karolinska Institute in Stockholm and colleagues.

“The results may indicate that a more severe or active PsA disease that requires antirheumatic treatment during pregnancy, especially bDMARDs, is associated with increased risks of adverse pregnancy outcomes compared to non-PsA pregnancies,” Dr. Remaeus and colleagues write in their study. “The risk of preterm birth in PsA pregnancies is further influenced by parity with the most increased risks observed in first pregnancies.”

In a nationwide, register-based cohort study, the researchers evaluated 921 pregnancies of women with PsA between 2007 and 2017, comparing them to the pregnancies of 9,210 women without PsA over the same time frame. The pregnancies for women with PsA were further categorized based on whether the women had not received antirheumatic treatment in the year prior to and/or during pregnancy (495 pregnancies) or had received antirheumatic treatment at any point in the year before and/or during pregnancy (426 pregnancies).

Of the women in the PsA group who were treated in the year prior to pregnancy (170 women), 39.4% received monotherapy with a conventional synthetic DMARD (csDMARD) such as an antimalarial, methotrexate, or sulfasalazine; 24.1% received oral corticosteroids, and 15.9% received a tumor necrosis factor inhibitor (TNFi), whereas about 20% of women received two or more antirheumatic drugs.

In the group of women treated during pregnancy (256 women), 153 did not receive bDMARDs; of these, 41.8% had monotherapy with either a csDMARD or corticosteroids, whereas the group treated with bDMARDs received TNFi monotherapy (43.7%) or TNFi with corticosteroids (35.9%), TNFi with csDMARD (9.7%), or TNFi with csDMARD plus corticosteroids (9.7%).

A majority of women in both groups (70.1%) were between ages 30 and 34 years (37.1%) or older than age 35 years (33%) and had delivered more than one child (63.2%). Women in the PsA group were more likely to be born in a Nordic country (91.8% vs. 82.8%), to have a body mass index between 30.0 and 60.0 kg/m² (19.9% vs. 12.6%), to be a smoker (9.2% vs. 5.3%), to have hypertension (1.4% vs. 0.8%) or diabetes (1.3% vs. 0.5%) prior to pregnancy, and to have a higher level of education (>12 years; 50.1% vs. 43.3%), compared with women in the non-PsA group.

The results showed women in the PsA group were more likely to experience preterm birth (adjusted odds ratio, 1.69; 95% confidence interval, 1.27-2.24) and undergo an elective (aOR, 1.77; 95% CI, 1.43-2.20) or emergency C-section (aOR, 1.42; 95% CI, 1.10-1.84). The group at highest risk for preterm birth with regard to parity was women with PsA having their first child (aOR, 3.95; 95% CI, 1.43-10.95).

Women who received antirheumatic treatment were at greater risk for experiencing preterm birth (aOR, 2.30; 95% CI, 1.49-3.56), and this risk was even higher for treatment with bDMARDs, compared with women without PsA (aOR, 4.49; 95% CI, 2.60-7.79). Use of bDMARDs also was associated with higher risks for spontaneous preterm birth (aOR, 4.73; 95% CI, 2.53-8.87), preterm birth between 32 and 36 weeks’ gestation (aOR, 5.06; 95% CI, 2.91-8.79), elective C-section (aOR, 2.72; 95% CI, 1.61-4.59), emergency C-section (aOR, 2.06; 95% CI, 1.04-4.07), and preeclampsia (aOR, 2.88, 95% CI, 1.35-6.17).

The researchers note that women with PsA should be evaluated for preterm birth particularly if they are having their first child, and “from a clinical point of view, all women with PsA, regardless of antirheumatic treatment, should be counseled about pregnancy outcomes and receive individualized monitoring during pregnancy.”

Are adverse outcomes linked to disease activity or treatment?

Patients in the study had a higher risk of adverse outcomes when they had a PsA diagnosis, and when they received antirheumatic treatment – but were the adverse outcomes associated with a patient’s high disease activity or need for antirheumatic treatment?

“Our interpretation is that a PsA disease that requires continued antirheumatic treatment during pregnancy is more severe than PsA that does not require treatment,” Dr. Remaeus and colleagues write. “Thus, the increased risk of adverse outcomes in pregnancies with maternal antirheumatic treatment is probably attributed to disease severity rather than an effect of the medication itself.”

Anja Strangfeld, MD, PhD, of the German Rheumatism Research Centre in Berlin, told this news organization that the results of the study are important because it is one of the first to report differences in risk in pregnancy outcomes for women with and without PsA.

“The information is relevant to guide rheumatologists in advising patients with PsA when planning the first or subsequent pregnancies,” she said. “The results are reassuring in reporting that the elevated risk for PsA patients for adverse pregnancy outcomes is low in patients not in need of antirheumatic medication, presumably in low-disease activity.”

However, the study is still unclear on whether the association with adverse pregnancy outcomes in patients is the result of higher disease activity or the need for antirheumatic treatment, she explained.

“It was only hypothesized that those patients under bDMARD treatment are/were in high disease activity. There [is] no information on disease activity in the data sources, which limits the results,” she said. “The investigation still does not solve the important question – if adverse pregnancy outcomes are rather related to high disease activity or the medication to treat this situation.”

There was no specific funding for this study. The study authors and Dr. Strangfeld have disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Disease-modifying antirheumatic drugs (DMARDs) such as biologics may carry an increased risk for preterm birth or cesarean delivery for pregnant women with psoriatic arthritis (PsA), according to a recent study published in Arthritis & Rheumatology.

zoranm/Getty Images

The risk was particularly high for women with PsA who received biologic disease-modifying antirheumatic drugs (bDMARDs), according to Katarina Remaeus, PhD, of the Karolinska Institute in Stockholm and colleagues.

“The results may indicate that a more severe or active PsA disease that requires antirheumatic treatment during pregnancy, especially bDMARDs, is associated with increased risks of adverse pregnancy outcomes compared to non-PsA pregnancies,” Dr. Remaeus and colleagues write in their study. “The risk of preterm birth in PsA pregnancies is further influenced by parity with the most increased risks observed in first pregnancies.”

In a nationwide, register-based cohort study, the researchers evaluated 921 pregnancies of women with PsA between 2007 and 2017, comparing them to the pregnancies of 9,210 women without PsA over the same time frame. The pregnancies for women with PsA were further categorized based on whether the women had not received antirheumatic treatment in the year prior to and/or during pregnancy (495 pregnancies) or had received antirheumatic treatment at any point in the year before and/or during pregnancy (426 pregnancies).

Of the women in the PsA group who were treated in the year prior to pregnancy (170 women), 39.4% received monotherapy with a conventional synthetic DMARD (csDMARD) such as an antimalarial, methotrexate, or sulfasalazine; 24.1% received oral corticosteroids, and 15.9% received a tumor necrosis factor inhibitor (TNFi), whereas about 20% of women received two or more antirheumatic drugs.

In the group of women treated during pregnancy (256 women), 153 did not receive bDMARDs; of these, 41.8% had monotherapy with either a csDMARD or corticosteroids, whereas the group treated with bDMARDs received TNFi monotherapy (43.7%) or TNFi with corticosteroids (35.9%), TNFi with csDMARD (9.7%), or TNFi with csDMARD plus corticosteroids (9.7%).

A majority of women in both groups (70.1%) were between ages 30 and 34 years (37.1%) or older than age 35 years (33%) and had delivered more than one child (63.2%). Women in the PsA group were more likely to be born in a Nordic country (91.8% vs. 82.8%), to have a body mass index between 30.0 and 60.0 kg/m² (19.9% vs. 12.6%), to be a smoker (9.2% vs. 5.3%), to have hypertension (1.4% vs. 0.8%) or diabetes (1.3% vs. 0.5%) prior to pregnancy, and to have a higher level of education (>12 years; 50.1% vs. 43.3%), compared with women in the non-PsA group.

The results showed women in the PsA group were more likely to experience preterm birth (adjusted odds ratio, 1.69; 95% confidence interval, 1.27-2.24) and undergo an elective (aOR, 1.77; 95% CI, 1.43-2.20) or emergency C-section (aOR, 1.42; 95% CI, 1.10-1.84). The group at highest risk for preterm birth with regard to parity was women with PsA having their first child (aOR, 3.95; 95% CI, 1.43-10.95).

Women who received antirheumatic treatment were at greater risk for experiencing preterm birth (aOR, 2.30; 95% CI, 1.49-3.56), and this risk was even higher for treatment with bDMARDs, compared with women without PsA (aOR, 4.49; 95% CI, 2.60-7.79). Use of bDMARDs also was associated with higher risks for spontaneous preterm birth (aOR, 4.73; 95% CI, 2.53-8.87), preterm birth between 32 and 36 weeks’ gestation (aOR, 5.06; 95% CI, 2.91-8.79), elective C-section (aOR, 2.72; 95% CI, 1.61-4.59), emergency C-section (aOR, 2.06; 95% CI, 1.04-4.07), and preeclampsia (aOR, 2.88, 95% CI, 1.35-6.17).

The researchers note that women with PsA should be evaluated for preterm birth particularly if they are having their first child, and “from a clinical point of view, all women with PsA, regardless of antirheumatic treatment, should be counseled about pregnancy outcomes and receive individualized monitoring during pregnancy.”

Are adverse outcomes linked to disease activity or treatment?

Patients in the study had a higher risk of adverse outcomes when they had a PsA diagnosis, and when they received antirheumatic treatment – but were the adverse outcomes associated with a patient’s high disease activity or need for antirheumatic treatment?

“Our interpretation is that a PsA disease that requires continued antirheumatic treatment during pregnancy is more severe than PsA that does not require treatment,” Dr. Remaeus and colleagues write. “Thus, the increased risk of adverse outcomes in pregnancies with maternal antirheumatic treatment is probably attributed to disease severity rather than an effect of the medication itself.”

Anja Strangfeld, MD, PhD, of the German Rheumatism Research Centre in Berlin, told this news organization that the results of the study are important because it is one of the first to report differences in risk in pregnancy outcomes for women with and without PsA.

“The information is relevant to guide rheumatologists in advising patients with PsA when planning the first or subsequent pregnancies,” she said. “The results are reassuring in reporting that the elevated risk for PsA patients for adverse pregnancy outcomes is low in patients not in need of antirheumatic medication, presumably in low-disease activity.”

However, the study is still unclear on whether the association with adverse pregnancy outcomes in patients is the result of higher disease activity or the need for antirheumatic treatment, she explained.

“It was only hypothesized that those patients under bDMARD treatment are/were in high disease activity. There [is] no information on disease activity in the data sources, which limits the results,” she said. “The investigation still does not solve the important question – if adverse pregnancy outcomes are rather related to high disease activity or the medication to treat this situation.”

There was no specific funding for this study. The study authors and Dr. Strangfeld have disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Key clinical point: In patients with psoriatic arthritis (PsA), 5 mg tofacitinib twice a day showed numerically better response with background ≥15 mg methotrexate per week. A twice daily dose of 10 mg tofacitinib, however, showed better response with background ≤15 mg methotrexate per week.

Major finding: In the 5 mg tofacitinib group, 51.4% vs. 47.4% of patients receiving background ≥15 mg methotrexate per week vs. ≤15 mg per week achieved American College of Rheumatology (ACR20) response at 3 months. However, in the 10 mg tofacitinib group, 54.9% vs. 51.8% of patients receiving ≤15 mg methotrexate per week vs. ≥15 mg per week achieved ACR20. No new safety risks were identified.

Study details: Findings are from pooled, post hoc exploratory analysis of 2 phase 3 trials, OPAL Broaden and OPAL Beyond, including 556 patients with active PsA randomly assigned to tofacitinib (5 mg or 10 mg twice daily) or placebo, with stable methotrexate.

Disclosures: This study was funded by Pfizer. Some of the authors reported ties with various sources, including Pfizer. C Wang and L Takiya declared being employees and shareholders of Pfizer.

Source: Kivitz AJ et al. Clin Rheumatol. 2021 Sep 12. doi: 10.1007/s10067-021-05894-2.

Key clinical point: In patients with psoriatic arthritis (PsA), 5 mg tofacitinib twice a day showed numerically better response with background ≥15 mg methotrexate per week. A twice daily dose of 10 mg tofacitinib, however, showed better response with background ≤15 mg methotrexate per week.

Major finding: In the 5 mg tofacitinib group, 51.4% vs. 47.4% of patients receiving background ≥15 mg methotrexate per week vs. ≤15 mg per week achieved American College of Rheumatology (ACR20) response at 3 months. However, in the 10 mg tofacitinib group, 54.9% vs. 51.8% of patients receiving ≤15 mg methotrexate per week vs. ≥15 mg per week achieved ACR20. No new safety risks were identified.

Study details: Findings are from pooled, post hoc exploratory analysis of 2 phase 3 trials, OPAL Broaden and OPAL Beyond, including 556 patients with active PsA randomly assigned to tofacitinib (5 mg or 10 mg twice daily) or placebo, with stable methotrexate.

Disclosures: This study was funded by Pfizer. Some of the authors reported ties with various sources, including Pfizer. C Wang and L Takiya declared being employees and shareholders of Pfizer.

Source: Kivitz AJ et al. Clin Rheumatol. 2021 Sep 12. doi: 10.1007/s10067-021-05894-2.

Key clinical point: In patients with psoriatic arthritis (PsA), 5 mg tofacitinib twice a day showed numerically better response with background ≥15 mg methotrexate per week. A twice daily dose of 10 mg tofacitinib, however, showed better response with background ≤15 mg methotrexate per week.

Major finding: In the 5 mg tofacitinib group, 51.4% vs. 47.4% of patients receiving background ≥15 mg methotrexate per week vs. ≤15 mg per week achieved American College of Rheumatology (ACR20) response at 3 months. However, in the 10 mg tofacitinib group, 54.9% vs. 51.8% of patients receiving ≤15 mg methotrexate per week vs. ≥15 mg per week achieved ACR20. No new safety risks were identified.

Study details: Findings are from pooled, post hoc exploratory analysis of 2 phase 3 trials, OPAL Broaden and OPAL Beyond, including 556 patients with active PsA randomly assigned to tofacitinib (5 mg or 10 mg twice daily) or placebo, with stable methotrexate.

Disclosures: This study was funded by Pfizer. Some of the authors reported ties with various sources, including Pfizer. C Wang and L Takiya declared being employees and shareholders of Pfizer.

Source: Kivitz AJ et al. Clin Rheumatol. 2021 Sep 12. doi: 10.1007/s10067-021-05894-2.

Key clinical point: Patients with psoriasis who experienced nail pitting, musculoskeletal symptoms, or inflammation or had high body mass index (BMI) were at a higher risk of developing psoriatic arthritis (PsA).

Major finding: Patients with psoriasis who had arthralgia (pooled risk ratio [pRR] 2.15; 95% CI 1.16-3.99) or imaging-detected musculoskeletal inflammation or structural damage (pRR 3.72; 95% CI 2.12-6.51) were at a significantly higher risk for PsA. Other predictors of PsA included nail pitting (pooled hazard ratio [HR] 2.14; 95% CI 1.32-3.46) and higher BMI (adjusted HR 1.17; 95% CI 1.04-1.31).

Study details: Findings are from a meta-analysis of 16 cohort studies and 10 case-control studies including patients with skin/nail psoriasis without a diagnosis of PsA.

Disclosures: This study was partially funded by Novartis Farma, Italy. The authors declared no conflict of interests.

Source: Zabotti A et al. Rheumatol Ther. 2021 Oct 10. doi: 10.1007/s40744-021-00378-w.

Key clinical point: Patients with psoriasis who experienced nail pitting, musculoskeletal symptoms, or inflammation or had high body mass index (BMI) were at a higher risk of developing psoriatic arthritis (PsA).

Major finding: Patients with psoriasis who had arthralgia (pooled risk ratio [pRR] 2.15; 95% CI 1.16-3.99) or imaging-detected musculoskeletal inflammation or structural damage (pRR 3.72; 95% CI 2.12-6.51) were at a significantly higher risk for PsA. Other predictors of PsA included nail pitting (pooled hazard ratio [HR] 2.14; 95% CI 1.32-3.46) and higher BMI (adjusted HR 1.17; 95% CI 1.04-1.31).

Study details: Findings are from a meta-analysis of 16 cohort studies and 10 case-control studies including patients with skin/nail psoriasis without a diagnosis of PsA.

Disclosures: This study was partially funded by Novartis Farma, Italy. The authors declared no conflict of interests.

Source: Zabotti A et al. Rheumatol Ther. 2021 Oct 10. doi: 10.1007/s40744-021-00378-w.

Key clinical point: Patients with psoriasis who experienced nail pitting, musculoskeletal symptoms, or inflammation or had high body mass index (BMI) were at a higher risk of developing psoriatic arthritis (PsA).

Major finding: Patients with psoriasis who had arthralgia (pooled risk ratio [pRR] 2.15; 95% CI 1.16-3.99) or imaging-detected musculoskeletal inflammation or structural damage (pRR 3.72; 95% CI 2.12-6.51) were at a significantly higher risk for PsA. Other predictors of PsA included nail pitting (pooled hazard ratio [HR] 2.14; 95% CI 1.32-3.46) and higher BMI (adjusted HR 1.17; 95% CI 1.04-1.31).

Study details: Findings are from a meta-analysis of 16 cohort studies and 10 case-control studies including patients with skin/nail psoriasis without a diagnosis of PsA.

Disclosures: This study was partially funded by Novartis Farma, Italy. The authors declared no conflict of interests.

Source: Zabotti A et al. Rheumatol Ther. 2021 Oct 10. doi: 10.1007/s40744-021-00378-w.

Key clinical point: Almost 80% of the effect of tofacitinib treatment on health-related quality of life (HRQoL) is primarily mediated by improvement in itch and Physician’s Global Assessment of psoriasis (PGA-PsO).

Major finding: Overall, 82.3% of the effect of tofacitinib on HRQoL as measured by the Dermatology Life Quality Index was contributed by improvement in itch score (P < .0001) and 17.7% was attributed to improvement in PGA-PsO score (P = 0.0006).

Study details: Findings are from a post hoc analysis of phase 3 trials OPAL Broaden and OPAL Beyond including 468 patients with active psoriatic arthritis (PsA), randomly assigned to tofacitinib (5 mg or 10 mg twice a day), adalimumab 40 mg (only in OPAL Broaden), or placebo.

Disclosures: This study was funded by Pfizer. The authors declared receiving grants or serving as consultants for several pharmaceutical companies, including Pfizer. Four authors declared being employees and stockholders of Pfizer.

Source: Taylor PC et al. J Clin Med. 2021 (Sep 9);10(18):4081. doi: 10.3390/jcm10184081.

Key clinical point: Almost 80% of the effect of tofacitinib treatment on health-related quality of life (HRQoL) is primarily mediated by improvement in itch and Physician’s Global Assessment of psoriasis (PGA-PsO).

Major finding: Overall, 82.3% of the effect of tofacitinib on HRQoL as measured by the Dermatology Life Quality Index was contributed by improvement in itch score (P < .0001) and 17.7% was attributed to improvement in PGA-PsO score (P = 0.0006).

Study details: Findings are from a post hoc analysis of phase 3 trials OPAL Broaden and OPAL Beyond including 468 patients with active psoriatic arthritis (PsA), randomly assigned to tofacitinib (5 mg or 10 mg twice a day), adalimumab 40 mg (only in OPAL Broaden), or placebo.

Disclosures: This study was funded by Pfizer. The authors declared receiving grants or serving as consultants for several pharmaceutical companies, including Pfizer. Four authors declared being employees and stockholders of Pfizer.

Source: Taylor PC et al. J Clin Med. 2021 (Sep 9);10(18):4081. doi: 10.3390/jcm10184081.

Key clinical point: Almost 80% of the effect of tofacitinib treatment on health-related quality of life (HRQoL) is primarily mediated by improvement in itch and Physician’s Global Assessment of psoriasis (PGA-PsO).

Major finding: Overall, 82.3% of the effect of tofacitinib on HRQoL as measured by the Dermatology Life Quality Index was contributed by improvement in itch score (P < .0001) and 17.7% was attributed to improvement in PGA-PsO score (P = 0.0006).

Study details: Findings are from a post hoc analysis of phase 3 trials OPAL Broaden and OPAL Beyond including 468 patients with active psoriatic arthritis (PsA), randomly assigned to tofacitinib (5 mg or 10 mg twice a day), adalimumab 40 mg (only in OPAL Broaden), or placebo.

Disclosures: This study was funded by Pfizer. The authors declared receiving grants or serving as consultants for several pharmaceutical companies, including Pfizer. Four authors declared being employees and stockholders of Pfizer.

Source: Taylor PC et al. J Clin Med. 2021 (Sep 9);10(18):4081. doi: 10.3390/jcm10184081.

Key clinical point: Despite failing to achieve 20% or higher improvement in American College of Rheumatology (ACR20) criteria at week 104, some patients with psoriatic arthritis (PsA) receiving long-term treatment with apremilast experienced meaningful clinical benefits not completely captured by ACR20 response criteria.

Major finding: At week 104 of apremilast treatment, 58.0%, 41.7%, and 44.3% of patients who failed to achieve ACR20 had a mean improvement in swollen joint count, tender joint count, and Physician’s Global Assessment scores, respectively. Additionally, 33.8% and 68.2% of these patients achieved resolution of enthesitis and dactylitis.

Study details: Findings are pooled analysis of phase 3 studies, PALACE 1, 2, and 3, and included patients randomly assigned to 30 mg apremilast twice daily and classified into those who did not achieve (n = 109) and those who achieved (n = 193) ACR20 response at week 104.

Disclosures: This study was funded by Celgene. All investigators reported ties with various sources including Celgene.

Source: Mease PJ et al. Rheumatol Ther. 2021 Sep 18. doi: 10.1007/s40744-021-00369-x.

Key clinical point: Despite failing to achieve 20% or higher improvement in American College of Rheumatology (ACR20) criteria at week 104, some patients with psoriatic arthritis (PsA) receiving long-term treatment with apremilast experienced meaningful clinical benefits not completely captured by ACR20 response criteria.

Major finding: At week 104 of apremilast treatment, 58.0%, 41.7%, and 44.3% of patients who failed to achieve ACR20 had a mean improvement in swollen joint count, tender joint count, and Physician’s Global Assessment scores, respectively. Additionally, 33.8% and 68.2% of these patients achieved resolution of enthesitis and dactylitis.

Study details: Findings are pooled analysis of phase 3 studies, PALACE 1, 2, and 3, and included patients randomly assigned to 30 mg apremilast twice daily and classified into those who did not achieve (n = 109) and those who achieved (n = 193) ACR20 response at week 104.

Disclosures: This study was funded by Celgene. All investigators reported ties with various sources including Celgene.

Source: Mease PJ et al. Rheumatol Ther. 2021 Sep 18. doi: 10.1007/s40744-021-00369-x.

Key clinical point: Despite failing to achieve 20% or higher improvement in American College of Rheumatology (ACR20) criteria at week 104, some patients with psoriatic arthritis (PsA) receiving long-term treatment with apremilast experienced meaningful clinical benefits not completely captured by ACR20 response criteria.

Major finding: At week 104 of apremilast treatment, 58.0%, 41.7%, and 44.3% of patients who failed to achieve ACR20 had a mean improvement in swollen joint count, tender joint count, and Physician’s Global Assessment scores, respectively. Additionally, 33.8% and 68.2% of these patients achieved resolution of enthesitis and dactylitis.

Study details: Findings are pooled analysis of phase 3 studies, PALACE 1, 2, and 3, and included patients randomly assigned to 30 mg apremilast twice daily and classified into those who did not achieve (n = 109) and those who achieved (n = 193) ACR20 response at week 104.

Disclosures: This study was funded by Celgene. All investigators reported ties with various sources including Celgene.

Source: Mease PJ et al. Rheumatol Ther. 2021 Sep 18. doi: 10.1007/s40744-021-00369-x.

Key clinical point: Patients with psoriasis with the most severe disease were at highest risk of developing psoriatic arthritis (PsA), highlighting the need for regular screening for signs and symptoms of PsA.

Major finding: Overall incidence of PsA in patients with mild, moderate, and severe psoriasis was 2.1 (95% CI 2.1-2.1), 9.9 (95% CI 9.5-10.4), and 17.6 (95% CI 16.9-18.3) events per 100 patient-years, respectively. The 5-year prevalence rate of PsA was highest for patients with severe psoriasis (54.9%) and lowest for those with mild psoriasis (9.9%).

Study details: Findings are from a retrospective analysis of the United States Electronic Health Records database including 114,868 patients with newly diagnosed psoriasis.

Disclosures: This study was funded by Novartis Pharmaceuticals Corporation, East Hanover, NJ. The investigators reported ties with several sources including Novartis. Some of the investigators declared being current or former employees of Novartis Pharmaceuticals Corporation, Novartis Pharma AG, or KMK Consulting, Inc.

Source: Merola JF et al. J Am Acad Dermatol. 2021 Sep 18. doi: 10.1016/j.jaad.2021.09.019.

Key clinical point: Patients with psoriasis with the most severe disease were at highest risk of developing psoriatic arthritis (PsA), highlighting the need for regular screening for signs and symptoms of PsA.

Major finding: Overall incidence of PsA in patients with mild, moderate, and severe psoriasis was 2.1 (95% CI 2.1-2.1), 9.9 (95% CI 9.5-10.4), and 17.6 (95% CI 16.9-18.3) events per 100 patient-years, respectively. The 5-year prevalence rate of PsA was highest for patients with severe psoriasis (54.9%) and lowest for those with mild psoriasis (9.9%).

Study details: Findings are from a retrospective analysis of the United States Electronic Health Records database including 114,868 patients with newly diagnosed psoriasis.

Disclosures: This study was funded by Novartis Pharmaceuticals Corporation, East Hanover, NJ. The investigators reported ties with several sources including Novartis. Some of the investigators declared being current or former employees of Novartis Pharmaceuticals Corporation, Novartis Pharma AG, or KMK Consulting, Inc.

Source: Merola JF et al. J Am Acad Dermatol. 2021 Sep 18. doi: 10.1016/j.jaad.2021.09.019.

Key clinical point: Patients with psoriasis with the most severe disease were at highest risk of developing psoriatic arthritis (PsA), highlighting the need for regular screening for signs and symptoms of PsA.

Major finding: Overall incidence of PsA in patients with mild, moderate, and severe psoriasis was 2.1 (95% CI 2.1-2.1), 9.9 (95% CI 9.5-10.4), and 17.6 (95% CI 16.9-18.3) events per 100 patient-years, respectively. The 5-year prevalence rate of PsA was highest for patients with severe psoriasis (54.9%) and lowest for those with mild psoriasis (9.9%).

Study details: Findings are from a retrospective analysis of the United States Electronic Health Records database including 114,868 patients with newly diagnosed psoriasis.

Disclosures: This study was funded by Novartis Pharmaceuticals Corporation, East Hanover, NJ. The investigators reported ties with several sources including Novartis. Some of the investigators declared being current or former employees of Novartis Pharmaceuticals Corporation, Novartis Pharma AG, or KMK Consulting, Inc.

Source: Merola JF et al. J Am Acad Dermatol. 2021 Sep 18. doi: 10.1016/j.jaad.2021.09.019.

Key clinical point: When choosing biologic medicines, patients with psoriatic arthritis (PsA) preferred oral medications and prioritized ability to work/lead a normal life and avoiding serious complications over clinical measures of improvement.

Major finding: Patients preferred oral vs. subcutaneous or intravenous routes (β coefficient 1.00; fixed parameter) and prioritized avoiding severe adverse events (β 0.72, 95% CI 0.50-0.95) and ability to attend normal activities (β 0.66; 95% CI 0.36-0.96) over improvement in enthesitis pain (β 0.28; 95% CI 0.20-0.36), psoriasis (β 0.28; 95% CI 0.20-0.36), and increasing chance of remission (β 0.27; 95% CI 0.19-0.36).

Study details: Findings are from a discrete choice experiment including 150 survey respondents with PsA, of which 75 patients were receiving biologics, 83 had an experience of biologic therapy, and 41 had an experience of 2 or more biologics.

Disclosures: The study had no funding to declare. Dr. Hassett declared receiving speaker fees or advisory board fees from AbbVie and Amgen.

Source: Sumpton D et al. Arthritis Care Res. 2021 Sep 13. doi: 10.1002/acr.24782.

Key clinical point: When choosing biologic medicines, patients with psoriatic arthritis (PsA) preferred oral medications and prioritized ability to work/lead a normal life and avoiding serious complications over clinical measures of improvement.

Major finding: Patients preferred oral vs. subcutaneous or intravenous routes (β coefficient 1.00; fixed parameter) and prioritized avoiding severe adverse events (β 0.72, 95% CI 0.50-0.95) and ability to attend normal activities (β 0.66; 95% CI 0.36-0.96) over improvement in enthesitis pain (β 0.28; 95% CI 0.20-0.36), psoriasis (β 0.28; 95% CI 0.20-0.36), and increasing chance of remission (β 0.27; 95% CI 0.19-0.36).

Study details: Findings are from a discrete choice experiment including 150 survey respondents with PsA, of which 75 patients were receiving biologics, 83 had an experience of biologic therapy, and 41 had an experience of 2 or more biologics.

Disclosures: The study had no funding to declare. Dr. Hassett declared receiving speaker fees or advisory board fees from AbbVie and Amgen.

Source: Sumpton D et al. Arthritis Care Res. 2021 Sep 13. doi: 10.1002/acr.24782.

Key clinical point: When choosing biologic medicines, patients with psoriatic arthritis (PsA) preferred oral medications and prioritized ability to work/lead a normal life and avoiding serious complications over clinical measures of improvement.

Major finding: Patients preferred oral vs. subcutaneous or intravenous routes (β coefficient 1.00; fixed parameter) and prioritized avoiding severe adverse events (β 0.72, 95% CI 0.50-0.95) and ability to attend normal activities (β 0.66; 95% CI 0.36-0.96) over improvement in enthesitis pain (β 0.28; 95% CI 0.20-0.36), psoriasis (β 0.28; 95% CI 0.20-0.36), and increasing chance of remission (β 0.27; 95% CI 0.19-0.36).

Study details: Findings are from a discrete choice experiment including 150 survey respondents with PsA, of which 75 patients were receiving biologics, 83 had an experience of biologic therapy, and 41 had an experience of 2 or more biologics.

Disclosures: The study had no funding to declare. Dr. Hassett declared receiving speaker fees or advisory board fees from AbbVie and Amgen.

Source: Sumpton D et al. Arthritis Care Res. 2021 Sep 13. doi: 10.1002/acr.24782.