New PsA Data Highlight Long-Term Benefits of Bimekizumab

Bimekizumab (Bimzelx, UCB) was approved by the FDA on September 23 to treat 3 inflammatory rheumatic conditions: psoriatic arthritis, non-radiographic axial spondyloarthritis, and ankylosing spondylitis.¹ The newest data presented on psoriatic arthritis at ACR Convergence 2024, the annual meeting of the American College of Rheumatology, mark the first presentation of updated data on the anti–interleukin-17A (IL)-17A, IL-17F, and IL-17AF monoclonal antibody since the approval.²

A trio of abstracts display long-term findings—at 1 year and at 2 years—from 2 phase 3 trials of 160-mg bimekizumab administered every 4 weeks, both of which were complete in 2022: BE OPTIMAL (NCT03895203) and BE COMPLETE (NCT03896581).^3,4 In these trials, bimekizumab was administered subcutaneously and results for patients naïve to treatment with a biologic disease-modifying antirheumatic drug (DMARD) or who had an inadequate response or were intolerant to a tumor necrosis factor (TNF) inhibitor, respectively, compared with placebo.

Disease Control⁵

Knowing the negative impact that psoriatic arthritis can have on the ability to work, the study investigators conducted this post-hoc investigation, using data to week 52 for BE OPTIMAL and week 40 for BE COMPLETE on work productivity and activity impairment (WPAI), with disease control evaluated via ACR response criteria (20%, 20%-50%, 50%-70%, 70% improvement), Disease Activity Index for PsA (DAPSA), minimal disease activity (MDA), and the composite end point of at least an ACR 50% improvement from baseline and Psoriasis Area and Severity Index 100% improvement from baseline (ACR50 + PASI100).

In BE OPTIMAL at week 52 and BE COMPLETE at week 40 compared with placebo, patients receiving bimekizumab who achieved ACR70, meaning 70% improvement in disease control; had low disease activity/were in remission; were responders per MDA criteria; and were responders per ACR50 + PASI100, missed less overall total work, had a higher level of presenteeism, and had less overall work and activity impairment vs those who achieved ACR20, still had a high degree of activity, and were nonresponders via MDA and ACR50 + PASI100.

Improvements were similar overall following treatment with bimekizumab in both trials, leading the authors to conclude that with greater disease control and lower disease activity come larger work productivity gains.

Response Duration⁶

For this subanalysis of data from BE OPTIMAL and BE COMPLETE, the study authors looked at the proportion of patients who had responded to bimekizumab treatment at week 16 and then evaluated them again at week 104 (BE OPTIMAL) and week 100 (BE COMPLETE). Efficacy was determined using ACR20/50/70; PASI75/90/100, disease activity level (minimal, very low), and DAPSA, with exposure-adjusted incidence rates (EAIR) measured per 100 patient-years at week 104 in both trials.

This trio of abstracts show the long-term benefits of bimekizumab through the 2-year mark. | Image Credit: © MQ-Illustrations-stock.adobe.com

Equivalent total patients had evaluable data at week 104 in BE OPTIMAL and week 100 in BE COMPLETE (83.3% and 80.5%, respectively), with the study authors noting that bimekizumab led to robust sustained responses in both groups at 2 years, as seen in these results:

• ACR50: at week 16, approximately 43% each of patients in BE OPTIMAL and BE COMPLETE achieved this, with high sustained response rates among these same patients of 79.4% and 75.7%, respectively, at weeks 104 and 100
• PASI100: at week 16, 47.5% and 58.5% of patients, respectively, had psoriasis affecting at least 3% of their body surface area, and by weeks 104 and 100, the overall response rate remained high, at 70.9% and 80.6% of each group
• MDA: this was achieved by 45% and 43.8% of patients, respectively, at week 16, with 75.8% and 74.4% maintaining this outcome at weeks 104 and 100

However, patients in BE OPTIMAL who experienced at least 1 treatment-emergent adverse event with treatment had a higher EAIR per 100 patient-years vs BE COMPLETE: 179.9 vs 100.3.

Pain and Fatigue⁷

Psoriatic arthritis also has a known negative impact on individuals’ quality of life because of the pain, fatigue, and functional limitations it imposes, the authors of this analysis explained, with most seeking significant and sustained disease relief through treatment. In this third subanalysis, the investigators evaluated pain via the Patient’s Assessment of Arthritis Pain Visual Analogue Scale (Pain VAS; 0-100, no pain to most severe pain) through week 104 of BE OPTIMAL and week 100 of BE COMPLETE, and fatigue via the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) subscale (0-52, worst to best) through weeks 104 and 88, respectively.

Overall completion rates for the trials were 83.3% for BE OPTIMAL and 80.5% for BE COMPLETE, and BE OPTIMAL had a reference arm through which patients also received 40-mg adalimumab every 2 weeks.

At baseline in BE OPTIMAL and BE COMPLETE, Pain VAS was a mean (SD) 56.8 (23.3) and 61.7 (24.6), respectively, in those who received placebo vs 53.6 (24.3) and 58.3 (24.2) in those who received bimekizumab. The reference arm, meanwhile, had a baseline pain VAS of 56.7 (23.9).

From baseline through weeks 104 and 100 for pain, close to half of all patients in all treatment groups in both trials experienced and were able to maintain at least a 50% reduction in their Pain VAS. For fatigue, from baseline through weeks 104 and 88, improvements seen at 1 year in all arms carried through to the 2-year mark.

References

1. McNulty R. FDA approves bimekizumab for psoriatic arthritis, nonradiographic axspa, ankylosing spondylitis. AJMC^®. September 23, 2024. Accessed November 19, 2024. https://www.ajmc.com/view/fda-approves-bimekizumab-for-psoriatic-arthritis-non-radiographic-axspa-ankylosing-spondylitis

2. Bimekizumab. Drugbank Online. Accessed November 19, 2024. https://go.drugbank.com/drugs/DB12917

3. A study to test the efficacy and safety of bimekizumab in the treatment of subjects with active psoriatic arthritis (BE OPTIMAL). ClinicalTrials.gov. Updated October 23, 2024. Accessed November 19, 2024. https://clinicaltrials.gov/study/NCT03895203

4. A study to evaluate the efficacy and safety of bimekizumab in the treatment of subjects with active psoriatic arthritis (BE COMPLETE). ClinicalTrials.gov. Updated October 16, 2024. https://clinicaltrials.gov/study/NCT03896581

5. Tillett W, Gladman D, Gossec L, et al. Achieving stringent disease control criteria was associated with greater work productivity improvements in patients with active psoriatic arthritis: results from two phase 3 studies of bimekizumab. Presented at: ACR Convergence; November 14-19, 2024; Washington, DC. Abstract 0587. https://acrabstracts.org/abstract/achieving-stringent-disease-control-criteria-was-associated-with-greater-work-productivity-improvements-in-patients-with-active-psoriatic-arthritis-results-from-two-phase-3-studies-of-bimekizumab/

6. Walsh JA, Merola JF, Ritchlin CT, et al. Bimekizumab maintained efficacy responses in patients with active psoriatic arthritis: up to 2-year results from two phase 3 studies. Presented at: ACR Convergence; November 14-19, 2024; Washington, DC. Abstract 0591. https://acrabstracts.org/abstract/bimekizumab-maintained-efficacy-responses-in-patients-with-active-psoriatic-arthritis-up-to-2-year-results-from-two-phase-3-studies/

7. Mease P, Tillett W, de Wit M, et al. Bimekizumab-treated patients with active psoriatic arthritis showed sustained improvements in pain and fatigue: up to 2-year results from two phase 3 studies. Presented at: ACR Convergence; November 14-19, 2024; Washington, DC. Abstract 2368. https://acrabstracts.org/abstract/bimekizumab-treated-patients-with-active-psoriatic-arthritis-showed-sustained-improvements-in-pain-and-fatigue-up-to-2-year-results-from-two-phase-3-studies/