UCB: Bimzelx Outperforms Skyrizi in Psoriatic Arthritis (49.1% vs 38.4%)
UCB announced on Tuesday data from the BE BOLD trial confirming the clinical superiority of Bimzelx (bimekizumab) over Skyrizi (risankizumab) in the treatment of psoriatic arthritis. With 49.1% of patients achieving the ACR50 target at 16 weeks compared to 38.4% for the competitor, Bimzelx becomes the first approved biological treatment to demonstrate this superiority in a head-to-head trial for this indication. These results, presented at the EULAR conference, strengthen the group's immuno-inflammatory portfolio in chronic joint diseases.
Joint Superiority Demonstrated as Early as Week 4
Bimzelx achieved its primary endpoint with an ACR50 rate of 49.1% at 16 weeks, compared to 38.4% for Skyrizi (p = 0.0078). This 10.7-point gap expresses a statistically significant difference in the improvement of joint symptoms. Earlier on, the response was also visible: at week 4, 19.9% of patients treated with Bimzelx reached ACR50 compared to 7.2% under Skyrizi, marking a 12.7-point lead at the beginning of treatment. On the criterion of complete disappearance of skin plaques (PASI100), 53.4% responded with Bimzelx and 46.6% with Skyrizi at 16 weeks. The BE BOLD trial included 553 adult participants with active psoriatic arthritis, randomized 1:1 between the two treatments. The double-blind was maintained until week 24.
An Advantage That Does Not Extend to All Secondary Criteria
While Bimzelx dominates on the ACR50, the results are nuanced on other markers. The Minimal Disease Activity (MDA) response was numerically more favorable with Bimzelx (43.0% vs 39.9%), without reaching statistical significance (p = 0.4408) according to the predefined testing hierarchy. The combined ACR50 + PASI100 criterion (joint disappearance of joint and skin symptoms) showed a numerical advantage for Bimzelx (33.5% vs 24.4%), without reaching significance (nominal p = 0.0800). No new safety signals were noted in either arm. Upper respiratory tract infections and oral candidiasis remain the most frequent adverse effects documented in previous trials.
