Watch to hear Dr James Del Rosso’s expert take on Bimzelx (bimekizumab) for psoriatic arthritis, including insights on clinical trial data, safety, and more. 

In September 2024, the US Food and Drug Administration (FDA) approved Bimzelx (bimekizumab-bkzx) for the treatment of active psoriatic arthritis (PsA) in adults. This approval introduced a treatment option for PsA with a dual-targeted mechanism that selectively inhibits both IL-17A and IL-17F, 2 key cytokines driving inflammatory processes. Bimzelx is also approved for the treatment of adults with moderate-to-severe plaque psoriasis, active nonradiographic axial spondyloarthritis, active ankylosing spondylitis, and moderate-to-severe hidradenitis suppurativa. 

Clinical data highlights 

Bimzelx’s approval was backed by robust data from two Phase 3 trials, BE OPTIMAL and BE COMPLETE, which demonstrated statistically significant results in both biologic disease-modifying anti-rheumatic drug (bDMARD-naive) and TNF inhibitor-inadequate responder (TNFi-IR) populations. 

Key findings 

• Joint symptoms (ACR50): At Week 16, 44% of bDMARD-naive patients and 43% of TNFi-IR patients receiving Bimzelx achieved ACR50, compared to 10% and 7% of patients receiving placebo, respectively 
• Minimal disease activity (MDA): Bimzelx delivered MDA in 45% of bDMARD-naive patients and 44% of TNFi-IR patients at Week 16, versus 13% and 6% in the placebo groups, with clinical responses generally sustained to Week 52 
• Complete skin clearance (PASI100): Among patients with baseline psoriasis affecting ≥3% of their body surface area, 47% of bDMARD-naive patients and 59% of TNFi-IR patients achieved PASI100 at Week 16, compared to 2% and 5% in the placebo groups, with clinical responses generally sustained to Week 52 

Safety snapshot 

Bimzelx demonstrated a safety profile consistent with prior studies. The most common adverse reactions (≥2%) included upper respiratory tract infections, oral candidiasis, headache, diarrhea, and urinary tract infections. 

Key takeaways 

• Mechanism of action: Bimzelx is the first FDA-approved PsA treatment targeting both IL-17A and IL-17F 
• Efficacy: In clinical trials, Bimzelx showed significant improvements in ACR50, MDA, and PASI100 by Week 16, with sustained results through Week 52 
• Safety: Common adverse reactions include upper respiratory tract infections, oral candidiasis, headache, diarrhea, and urinary tract infections 
• Impact: Bimzelx provides a versatile option for biologic-naive and TNFi-inadequate responders