UCB’s Bimzelx (bimekizumab) Receives EC’s Marketing Authorisation for the Treatment of Psoriatic Arthritis and Axial Spondyloarthritis
Shots:
- The approval was based on the P-III studies (BE OPTIMAL & BE COMPLETE) in 1252 patients with PsA evaluating bimekizumab (160mg, q4w) & (BE MOBILE 1 & 2) trial in 586 patients with active axSpA
- Both trials met its 1EPs & 2EPs i.e., patients with bimekizumab in PsA achieved ACR50 response in bDMARD-naive & TNFi-IR patients (44% vs 10%) & (43% vs 7%); MDA (45% vs 13%) & (44% vs 6%) @16wk.; patients with baseline psoriasis affecting ≥3 percent body surface area achieved complete skin clearance (PASI100) in (47% vs 2%) & (59% vs 5%), respectively. Clinical responses were sustained up to 52wk. in (BE OPTIMAL) trial
- In nr-axSpA & AS populations, ASAS40 response (47.7% vs 21.4%) & (44.8% vs 22.5%); low disease activity (46.2% vs 20.6%) & (44.9% vs 17.5%) @16wk., 6 out of 10 patients achieved ASDAS<2.1 @52wk., reduction of objective inflammatory signs in sacroiliac joints & spine @16 & 52wk.
Ref: UCB | Image: UCB
Related News:- UCB’s Bimzelx (bimekizumab) Receives Health Canada’s Approval for the Treatment of Plaque Psoriasis
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Neha is a Senior Editor at PharmaShots. She is passionate and very enthusiastic about recent updates and developments in the life sciences and pharma industry. She covers Biopharma, MedTech, and Digital health segments along with different reports at PharmaShots. She can be contacted at connect@pharmashots.com.
