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axSpA and axPsA Treatment and Health Disparities

CME

ACR 2021: New Data on axSpA and axPsA Treatment Options and Health Disparities in Patients With Axial Disease

Physicians: Maximum of 0.25 AMA PRA Category 1 Credit™

Released: December 22, 2021

Expiration: December 21, 2022

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Several abstracts were presented at the recent meeting of the American College of Rheumatology (ACR) that provide insights for our treatment of patients with ankylosing spondylitis and psoriatic arthritis.

BE AGILE Study: 3-Year Data on Bimekizumab
Bimekizumab is a monoclonal immunoglobulin G1 antibody with a new mode of action in that it selectively inhibits both interleukin (IL)‑17F and IL‑17A. Three-year data from BE AGILE, a double‑blind, placebo‑controlled, dose‑ranging phase IIb study, were presented at ACR 2021. Between Week 12 and 48, all patients received bimekizumab, either 160 mg or 320 mg (ie, no one got placebo), subcutaneously every 4 weeks. Beyond Week 48, everyone received 160 mg in an open-label extension; 160 mg is the dose chosen for phase III studies. The primary endpoint was the Assessment of SpondyloArthritis international Society 40 (ASAS40) response at Week 12. A nonresponder imputation (NRI) was done for missing data.

Primary endpoint data had been reported earlier. At Week 12, significantly more patients receiving bimekizumab achieved ASAS40 vs placebo (NRI: 29.5%-46.7% vs 13.3%). At Week 48, 58.6% and 62.3% of patients receiving bimekizumab 160 mg and 320 mg throughout the study achieved ASAS40, respectively, by NRI analysis. This report at Week 156 demonstrated that rates of both ASAS40 and Ankylosing Spondylitis Disease Activity Score (ASDAS) <2.1 were maintained in those who continued receiving bimekizumab 160 mg. 

This abstract also reported long-term safety results. Overall, the exposure-adjusted incident rate of treatment-related adverse events in the extension phase remained stable or was lower than in Weeks 0-48. Most Candida infections were oral, and all were judged mild or moderate. Rates of inflammatory bowel disease, anterior uveitis, and injection-site reactions were low across the 156 weeks.

So, in this 3‑year study of BE AGILE on this IL‑17A/IL‑17F inhibitor, bimekizumab was shown to be efficacious, and no new safety signals were seen.

GO ALIVE: Golimumab in Ankylosing Spondylitis
GO ALIVE is another study in patients with ankylosing spondylitis that I’d like to discuss. Early, aggressive treatment is the mantra for rheumatology and in rheumatoid arthritis: To avoid real structural damage associated with long-term disease, we want to treat early, and we want to treat aggressively. Of interest, in ankylosing spondylitis, not much data support that supposition. This analysis of the GO ALIVE study hoped to provide those data. 

GO ALIVE is a large, double-blind, placebo-controlled phase III trial studying IV golimumab, a monoclonal antibody directed against tumor necrosis factor-α, in patients with ankylosing spondylitis. This post hoc analysis studied strata of patients classified as having early vs late disease based on quartiles of symptom duration. Early disease (first quartile) was defined as inflammatory back pain of <4 years (n = 60). Late disease (fourth quartile) was defined as inflammatory back pain of >15.5 years (n = 52). For patients with early disease, the mean duration of symptoms was approximately 2.5 years; for patients with late disease, it was approximately 24 years. Patients with early disease were on average 10 years younger than patients with late disease.

At Week 16, a higher percentage of patients with early disease had a better response compared with patients with late disease. Among those receiving IV golimumab, ASAS20 was achieved by 72% of patients with early disease and 67% with late disease. If one looks at more stringent endpoints, patients with early disease had numerically better responses than those with late disease in the following: Bath Ankylosing Spondylitis Functional Index (-2.3 vs -2.2 mean change from baseline, respectively), Bath Ankylosing Spondylitis Metrology Index (-0.4 vs -0.3 mean change from baseline), ASAS40 (46% vs 42%), Bath Ankylosing Spondylitis Disease Activity Index 50% improvement (BASDAI 50; 40% vs 33%), and the ASDAS inactive disease score (17% vs 8% with score ≥1.3) and major improvement score (57% vs 48% with decrease of ≥2). There also was a slight difference in adverse events. Treatment-emergent adverse events and serious adverse events through 52 weeks were found in 46% and 3% of patients with early disease vs 61% and 2% of patients with late disease, respectively.

So, it is important to treat patients early. Patients with early‑onset disease really achieve these high-hurdle endpoints, which signify real improvement in symptoms. Treating patients early and aggressively gives a much better outcome.

Ixekizumab in Psoriatic Arthritis: Post Hoc Analysis of SPIRIT-P1 and SPIRIT-P2
The next 2 abstracts will deal with psoriatic arthritis. The rheumatology community is very interested in axial involvement in patients with psoriatic arthritis. We previously thought that the axial involvement of psoriatic arthritis was nothing more than ankylosing spondylitis with psoriasis. We are slowly finding out that there is a pattern in which the spine gets involved—that is, it is bilaterally symmetrical in axial spondyloarthritis but asymmetrical in axial psoriatic arthritis. We see a similar pattern with the sacroiliac joint. And, of more importance, there is a difference in response between the 2 drugs that target IL-23: no response in ankylosing spondylitis but good response in peripheral psoriatic arthritis. 

The study I’d like to describe is a post hoc analysis of SPIRIT-P1 and SPIRIT-P2. Both included patients with active psoriatic arthritis, and this analysis looks at the subset of patients from both studies who have axial involvement. In SPIRIT-P1, patients were naive to biologics at entry, and in SPIRIT-P2, they were intolerant to 1 or 2 tumor necrosis factor (TNF) inhibitors or had an inadequate response to them. The prevalence of axial involvement varied between 25% and 70% in the group included for analysis. The objective of this analysis was to determine the efficacy of ixekizumab, a monoclonal antibody that targets IL-17, in reducing axial symptoms and improving quality of life at 52 weeks vs placebo. In total, 313 patients were included: 162 receiving ixekizumab and 151 receiving placebo.

What we found was that patients receiving ixekizumab had much greater improvement in axial symptoms and quality of life measures compared with those receiving placebo at as early as Week 16, and the improvement continued through Week 52 in measures such as ASDAS, BASDAI 50, metastatic BASDAI, and SF-36. This study also provides more evidence about which drugs work specifically for axial psoriatic arthritis and whether this is a unique disease altogether vs axial involvement of ankylosing spondylitis.

Racial Disparities in Psoriatic Arthritis
The final paper deals with racial disparities in comorbidities in patients with psoriatic arthritis. The racial heterogeneity in the US population makes it imperative that we understand the differences in the clinical characteristics, medication use, and comorbidities related to the disease entities of interest.

This was a retrospective study in which the authors used the IBM Explorys platform to survey 26 major integrated healthcare systems in the United States. Psoriatic arthritis was defined as ≥2 visits with a rheumatologist between 1999 and 2019 in patients with a diagnosis of psoriatic arthritis. In total, 26,010 patients with psoriatic arthritis were identified: 95% were White, 5% were Black, and 63% were female. In addition, 17% were smokers, and there was a significantly higher level of smoking in White patients compared with Black patients.

Among arthritis and inflammatory symptoms, enthesopathy was significantly more common in Black patients, but peripheral arthritis, onycholysis, elevated C-reactive protein, and elevated erythrocyte sedimentation rate were significantly more common in White patients.

Certain comorbidities were significantly more common in Black patients than in White patients: hypertension, diabetes, obesity, gout, and uveitis. Malignancy, anxiety, and osteoporosis were significantly more common in White patients.

Treatment differences also were noted between racial groups. Nonsteroidal anti-inflammatory drugs were used in 80% of White patients and 78% of Black patients (P <.0097). TNF inhibitors were used in 51% of White patients and 41% of Black patients (P <.0001). Disease-modifying antirheumatic drugs were used in 72% of White patients and 98% of Black patients (P <.0001).

Your Thoughts?
Which of the studies described in this commentary will most likely influence your approach to assessing and managing patients with ankylosing spondylitis and psoriatic arthritis? Please answer the polling question and leave a comment in the box below.

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