Key Differences in Inclusion Criteria Between BE OPTIMAL and BE COMPLETE

EP: 1.Background on PROs in Psoriatic Arthritis

EP: 2.Common Symptoms and Treatments in Psoriatic Arthritis

EP: 3.Treatment Selection for Psoriatic Arthritis

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EP: 4.Key Differences in Inclusion Criteria Between BE OPTIMAL and BE COMPLETE

The BE OPTIMAL and BE COMPLETE studies employed distinct patient populations to comprehensively evaluate bimekizumab efficacy across different treatment contexts. BE OPTIMAL enrolled biologic-naive patients who had never received biologic therapy, whereas BE COMPLETE focused on TNF-alpha inhibitor inadequate responders or intolerant patients. Both phase 3 trials utilized randomized, double-blind, placebo-controlled designs extending to 16 weeks, with placebo patients switching to active treatment thereafter. BE OPTIMAL employed a 3:2:1 randomization including an adalimumab reference arm, whereas BE COMPLETE compared bimekizumab directly against placebo.

This dual-study approach reflects the evolution of clinical trial design in an era where many patients have prior biologic exposure, contrasting with early TNF inhibitor trials when patients were universally bio-naive. Historically, biologic-experienced populations demonstrate blunted treatment responses compared with treatment-naive patients, attributed to subtle immunophenotype changes following previous biologic exposure. The different patient populations require separate evaluations to provide clinicians with realistic expectations for treatment outcomes in both scenarios.

The primary end point selection of ACR50 response at 16 weeks represents a more stringent efficacy threshold than traditionally used in psoriatic arthritis trials, emphasizing robust treatment responses. Both studies prioritized patient-reported outcomes, including pain, fatigue, work function, productivity and health-related quality of life as key secondary end points. Notably, the bimekizumab data demonstrated minimal difference in efficacy between bio-naive and TNF-experienced populations, with similar ACR50 responses and minimal disease activity achievement rates across both studies, suggesting maintained effectiveness regardless of prior treatment exposure.