New two-year data showed sustained improvements in clinical and patient-reported outcomes in active psoriatic arthritis (PsA) among patients treated with bimekizumab-bkzx (Bimzelx, UCB).
These findings will be highlighted at the American College of Rheumatology (ACR) Convergence 2024 in Washington DC.
Bimekizumab-bkzx received FDA approval for PsA, non-radiographic axial spondyloarthritis (nr-axSpA), and ankylosing spondylitis (AS) in Sept. 2024. The interleukin 17A (IL-17A) and IL-17F blocker was approvedfor the treatment of moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy in Oct. 2023
For psoriatic arthritis patients, the new data demonstrated robust maintenance of clinical responses, including complete skin clearance (PASI100), minimal disease activity, improvements in joint pain, and patient reported outcomes to two years. More than seven in 10 of Week 16 responders sustained a 50% improvement in ACR response criteria (ACR50) at two years. Maintenance of response was consistent regardless of whether patients were biologic disease-modifying anti-rheumatic drug-naïve (bDMARD-naïve: BE OPTIMAL) or had a previous inadequate response or intolerance to tumor necrosis factor inhibitors (TNFi-IR: BE COMPLETE).
Complete skin clearance (Psoriasis Area and Severity Index [PASI]100) experienced at Week 16 in patients with baseline psoriasis affecting ≥3% body surface area (47.5% of 103 patients in BE OPTIMAL and 58.5% of 103 patients in BE COMPLETE) was maintained to two years by 70.9% of 73 bDMARD-naïve patients in BE OPTIMAL and 80.6% of 83 TNFi-IR patients in BE COMPLETE.
Similar trends were seen for minimal disease activity (MDA) response. Of those who experienced MDA at Week 16 (45.0% of 194 patients in BE OPTIMAL and 43.8% of 117 patients in BE COMPLETE), 75.8% of 147 bDMARD-naïve patients and 74.4% of 87 TNFi-IR patients maintained response to two years.
Improvements in pain at one year were sustained up to two years, with approximately half of patients in all treatment groups experiencing a ≥50% reduction in Pain Visual Analog Scale (Pain VAS) at two years.
Fatigue was assessed using the Functional Assessment of Chronic Illness Therapy-Fatigue subscale (FACIT-Fatigue). Minimal clinically important difference (MCID) in FACIT-Fatigue scores (as defined by ≥4-point increase from baseline in patients with FACIT-Fatigue ≤48 at baseline) was achieved by nearly 5 in 10 patients in both BE OPTIMAL and BE COMPLETE with results sustained from Week 52.
In addition, a two pooled safety analysis, each comprising three Phase 2b/3 studies and their open-label extensions, in patients with active nr-axSpA, AS, and active PsA confirmed that the long-term safety profile was consistent with previous studies.
