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.
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.
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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.
SectorPharmacie et biotechnologies›Vaccins et laboratoires de recherche
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Context
Period
Period: S1 2026
Key reported figures
Revenue: 4 270 millions d'euros
Quarterly revenue: 4 270 millions d'euros
Revenue growth: 22,5 %
EBITDA: 1 685 millions d'euros
EBITDA margin: 40,7 %
Net income: 1 111 millions d'euros
2 821 millions d'euros
Guidance from the release
Based on the continued strong growth, revenue is expected to grow in the low-teens to mid-teens percentage range; Reflecting our strong execution and confidence in the outlook
Risks mentioned
Perte d'exclusivité de BRIVIACT aux États-Unis depuis février 2026 et en Europe attendue en août 2026
Ventes de VIMPAT au Japon affectées par l'arrivée de génériques fin 2025
Expiration en 2026 de la protection brevetaire de CIMZIA au Japon
Opportunities identified
Objectif de ventes maximales de BIMZELX relevé à au moins 7 milliards d'euros
Supériorité de BIMZELX sur risankizumab dans le rhumatisme psoriasique (étude BE BOLD)
FINTEPLA déposé dans le syndrome CDKL5 auprès de la FDA et de l'EMA, Phase 3 lancée dans le syndrome de Rett
Outlook / guidance
Management commentary: revenue is expected to grow in the low-teens to mid-teens percentage range at constant exchange rates (CER). Adjusted EBITDA² is expected to grow in the mid-teens to low-twenties percentage range at CER. Excluding other operating one-offs in 2025, adjusted EBITDA² growth is expected to be in the mid-twenties to low-thirties percentage range at CER.
The information presented in this article is provided for informational purposes only and does not constitute an investment recommendation, an incentive to buy or sell a financial asset, or investment advice. Readers are invited to conduct their own research before making any decision.
Investments in the stock market involve risks, including the risk of capital loss. Past performance of an asset or market is no guarantee of future results. Any investment decision should be made taking into account your personal financial situation, objectives and risk tolerance.