Jeffrey Stark, MD: Bimekizumab Achieves Primary and Secondary Endpoints for Treatment of Psoriatic Arthritis

Rheumatology Network interviewed Jeffrey Stark, MD, to discuss the BE COMPLETE study results. Stark is the Head of Immunology Medical Affairs at UCB.

Psoriatic arthritis (PsA), a heterogeneous, systemic, inflammatory condition, can affect patients in a multitude of ways, with up to 25% of the population is currently experiencing the condition. Symptoms include inflammation of the skin, tendons, and ligaments, as well as dactylitis and enthesitis.

Stark explained that because PsA remains a residual unmet need and “there still are patients who, despite the treatment options available, still suffer with significant manifestations and experience and impact on their quality of life.”

BE COMPLETE was one of 2 phase 3 studies conducted by UCB that examines the safety and efficacy of bimekizumab in patients with PsA. The randomized, multicenter, double-blind study enrolled 400 patients with PsA who received either bimekizumab or a placebo. While the full results have yet to be published, Stark emphasized that the BE COMPLETE study met its primary endpoint of American College of Rheumatology (ACR) 50 response by week 16. It also met the secondary endpoints, including important measures of disease impact and disease activity, as measured by skin clearance, Psoriasis Area and Severity Index (PASI 90), the Health Assessment Questionnaire Disability Index (HAQ-DI), minimal disease activity (MDA), and the 36-Item Short Form Health Survey (SF-36).

Patients included in the study were treatment resistant, with inadequate responses or intolerance to tumor necrosis factor alpha (TNF-α) therapy. Treating this patient population would theoretically be more challenging and make achieving these endpoints more difficult.

There were no new safety signals of bimekizumab treatment identified during the study. “Safety is always top of mind for us in the rheumatology community, and it’s very important to consider both the risks and the benefits of treatment as we make treatment decisions for our patients,” Stark stated.

While bimekizumab has not been approved for the treatment of PsA, UCB is committed to pursuing that regulatory pathway for the drug. Despite available treatments, there are still many people living with the rheumatic disease who are inadequately treated. Bimekizumab may be a useful option to control inflammation and disease activity to ultimately enhance quality of life.

View the interview below: