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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