Home > Rheumatology > ACR 2024 > Psoriatic Arthritis > Meet the Trialist: Prof. Philip J. Mease on the bimekizumab clinical trial program in psoriatic arthritis

Meet the Trialist: Prof. Philip J. Mease on the bimekizumab clinical trial program in psoriatic arthritis

Expert
Prof. Philip J. Mease, Swedish Medical Center/Providence-St. Joseph Health, Seattle, WA, USA
Conference
ACR 2024
Trial
Phase 3, BE OPTIMAL, BE COMPLETE, BE VITAL
The phase 3 BE OPTIMAL, BE COMPLETE, and BE VITAL studies evaluated bimekizumab, a monoclonal IgG1 antibody inhibiting IL-17A and IL-17F, in psoriatic arthritis (PsA). Medicom Medical Publishers spoke with Prof. Philip J. Mease (Swedish Medical Center/Providence-St. Joseph Health, Seattle, WA, USA) about the updates of these 3 studies, presented at the ACR Convergence 2024.

BE OPTIMAL (NCT03895203) assessed bimekizumab in biologic DMARD-naïve patients, comparing it with placebo and adalimumab over 52 weeks [1]. BE COMPLETE (NCT03896581) focused on patients with inadequate response or intolerance to TNF inhibitors, evaluating bimekizumab’s efficacy over 16 weeks [2]. BE VITAL (NCT04009499), an open-label extension study, provided long-term data for up to 2 years, demonstrating sustained safety, efficacy, and patient-reported outcomes such as improvements in pain, fatigue, and work productivity [3].
Can you summarise the findings from the BE OPTIMAL study regarding pain and fatigue?

“Absolutely. PsA is characterised by joint and skin inflammation, significantly impacting quality-of-life through pain and fatigue. In the BE OPTIMAL and BE COMPLETE studies, we evaluated bimekizumab. Over 2 years, participants experienced sustained improvements in fatigue, as measured by the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) subscale [4]. Similarly, pain improvements were consistent across the study duration. Notably, even patients who transitioned from adalimumab to bimekizumab at week 52 maintained these benefits through 2 years.”

“Our analysis from the BE OPTIMAL and BE COMPLETE trials also evaluated the relationship between achieving stringent control of swollen joint count (SJC) and reductions in patient-reported pain and fatigue. The data showed that patients who attained complete resolution of swollen joints (SJC=0) experienced the greatest improvements in pain and fatigue, sustained over 2 years. It is so important to target the full resolution of joint inflammation as a key therapeutic goal.”
The dual inhibition of IL-17A and IL-17F by bimekizumab seems to play a pivotal role. How does this mechanism contribute?

“While IL-17A has been a primary target in PsA, recent evidence suggests IL-17F also drives inflammation and tissue damage. By targeting both cytokines, bimekizumab achieves a broader suppression of inflammation. This dual mechanism likely underpins the consistent and sustained improvements in symptoms like fatigue and pain that we’ve observed in these studies.”
What did the BE OPTIMAL and BE COMPLETE studies reveal about work productivity?

“PsA can significantly impair work productivity, affecting absenteeism, presenteeism, and overall activity levels. Using the Work Productivity and Activity Impairment Questionnaire (WPAI-SHP), we found that bimekizumab demonstrated significant and clinically meaningful improvements across all dimensions of work productivity compared with placebo by week 16 [5]. Importantly, these improvements were sustained over 1 year, and patients who transitioned from placebo to bimekizumab experienced similar benefits.“
Were there any differences in work productivity outcomes between biologic-naïve patients and those with prior TNF inhibitor exposure?

“Interestingly, improvements in work productivity were consistent across both biologic DMARD-naïve and TNF inhibitor-experienced populations. By week 16, biologic-naïve patients treated with bimekizumab showed a 16.7% improvement in overall work impairment compared with 3.0% in the placebo group. For TNF inhibitor-experienced patients, the improvement was 15.6% for bimekizumab versus 3.6% for placebo. These gains continued to increase over the year-long study period, reinforcing the efficacy of bimekizumab across diverse patient populations.”
Beyond clinical trial results, you’ve mentioned the importance of real-world creativity in managing PsA, particularly with off-label combination therapies. Could you elaborate?

“’PsA is a heterogeneous disease, and we sometimes need to think outside the box. For instance, dermatologists may prescribe TNF-alpha inhibitors for severe skin involvement, while rheumatologists might focus on IL-23 or IL-17 inhibitors for joint symptoms. Sometimes we can get around off-label combination therapies by coordinating who-prescribes-what and get even better results. This flexibility allows us to tailor treatment to each patient’s unique needs.”
Do you have any final thoughts on what these updates mean for patients?

“The ability to target both IL-17A and IL-17F with bimekizumab represents a significant advance in PsA management. It addresses not only the physical manifestations of the disease but also the broader impact on patients’ lives, such as fatigue and work productivity, with robust safety data and sustained efficacy over 2 years, and soon 3 years. The data highlights the need for clinicians to prioritise comprehensive disease control, including stringent SJC resolution, when tailoring treatment plans. While I can’t discuss specifics before its presentation at the EULAR 2025, I can tell you the 3-year data looks very positive.”

  1. McInnes IB, et al. Lancet. 2023 Jan 7;401(10370):25-37.
  2. Merola JF, et al. Lancet. 2023 Jan 7;401(10370):38-48.
  3. Coates LC, et al. RMD Open. 2024 Feb 22;10(1):e003855.
  4. Mease PJ, 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. Abstract 2368, ACR Convergence 2024, 14–19 November, Washington DC, USA.
  5. Mease PJ, et al. Bimekizumab Treatment Impact on Work Productivity in Biologic DMARD‑Naïve and TNFi-IR Patients with Active Psoriatic Arthritis: Results up to 1 Year from Two Phase 3 Studies. Abstract 1415, ACR Convergence 2024, 14–19 November, Washington DC, USA.

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