Bimekizumab Shows Sustained Efficacy in Psoriatic Arthritis at 2 Years

Key Insights

• Bimekizumab demonstrates durable efficacy in psoriatic arthritis (PsA) across diverse patient populations, including those new to biologic treatments and those with TNF inhibitor resistance.
• In clinical trials, over 70% of patients achieving ACR50 response at week 16 maintained it at 2 years, with significant skin clearance rates observed in both bDMARD-naïve and TNFi-IR groups.
• Patients on bimekizumab reported sustained reductions in pain and fatigue, with almost half experiencing a ≥50% decrease in pain and improvements in fatigue scores over the 2-year period.

New data presented at the American College of Rheumatology (ACR) Convergence 2024 highlights the sustained efficacy and safety of bimekizumab (Bimzelx) in treating psoriatic arthritis (PsA) and axial spondyloarthritis (axSpA). The findings, derived from phase 3 clinical trials and their long-term extensions, reinforce bimekizumab's potential as a significant advancement for these chronic inflammatory conditions.

Sustained Clinical Response

The data showcased bimekizumab’s durable efficacy in PsA across various patient groups, including those who had not previously used biologic disease-modifying anti-rheumatic drugs (bDMARD-naïve) and those with inadequate responses to tumor necrosis factor inhibitors (TNFi-IR). In the BE OPTIMAL and BE COMPLETE trials, over 70% of patients who achieved a 50% improvement based on the American College of Rheumatology response criteria (ACR50) at week 16 maintained this response at 2 years. Specifically, 79.4% of bDMARD-naïve patients and 75.7% of TNFi-IR patients sustained the ACR50 response.

Skin Clearance and Minimal Disease Activity

Complete skin clearance, measured by PASI100, was achieved by 70.9% of bDMARD-naïve patients and 80.6% of TNFi-IR patients over the 2-year period. Among patients who attained minimal disease activity at week 16, nearly 75% sustained this outcome at 2 years, indicating a consistent and prolonged therapeutic effect.

Patient-Reported Outcomes

Patients treated with bimekizumab reported sustained reductions in pain and fatigue. Almost half of the patients experienced a ≥50% decrease in pain, alongside improvements in fatigue scores, demonstrating the drug's impact on enhancing the quality of life for individuals with PsA and axSpA.

Safety Profile

Long-term safety analyses, combining data from six studies, revealed a consistent safety profile for bimekizumab. The most common treatment-emergent adverse events included COVID-19 (20.9%), nasopharyngitis (15.7%), and upper respiratory tract infection (13.6%). These findings support the drug's tolerability over extended use.

Expert Commentary

Dr. Fabian Proft of Charité Universitätsmedizin Berlin emphasized the significance of these results, stating that bimekizumab's dual inhibition mechanism offers a long-term solution for managing inflammation and disease progression in patients with PsA and axSpA. He added that the two-year data reinforces its potential to set new benchmarks in rheumatology care.

Bimekizumab's efficacy across multiple domains and sustained response over 2 years address a significant unmet need, particularly for patients who have experienced treatment failures with existing options, marking it as a critical addition to the therapeutic landscape for PsA and axSpA.