Bimzelx

The approval was based on data from the phase 3 BE VIVID (ClinicalTrials.gov Identifier: NCT03370133), BE READY (ClinicalTrials.gov Identifier: NCT03410992), and BE SURE (ClinicalTrials.gov Identifier: NCT03412747) trials, which included 1480 adults with moderate to severe plaque psoriasis. The coprimary endpoints for all 3 studies were the proportion of patients who achieved an Investigator’s Global Assessment (IGA) score of 0 (“clear”) or 1 (“almost clear”) with at least a 2-grade improvement from baseline and the proportion of patients who achieved at least a 90% reduction from baseline Psoriasis Area and Severity Index 90 (PASI 90) response at week 16.

Findings from BE VIVID and BE READY showed that a greater proportion of patients treated with bimekizumab met the following endpoints at week 16 vs placebo, respectively:

• IGA 0 or 1: 84% vs 5% (BE VIVID); 93% vs 1% (BE READY).
• PASI 90: 85% vs 5% (BE VIVID); 91% vs 1% (BE READY).
• IGA 0: 59% vs 0% (BE VIVID); 70% vs 1% (BE READY).
• PASI 100: 59% vs 0% (BE VIVID); 68% vs 1% (BE READY).
• PASI 75 (at week 4): 77% vs 2% (BE VIVID); 76% vs 1% (BE READY).
• Scalp IGA response of 0 or 1 with at least a 2-grade improvement from baseline: 84% vs 15% (BE VIVID); 92% vs 7% (BE READY).

In BE READY, the continued use of bimekizumab was associated with statistically significant responses at week 56 during the randomized-withdrawal period.

Additionally, the BE SURE study evaluated the efficacy and safety of bimekizumab in 478 adults with chronic plaque psoriasis for ≥6 months with an affected body surface area of ≥10%, Psoriasis Area and Severity Index (PASI 90) of ≥12 and Investigator Global Assessment (IGA) score ≥3 on a 5-point scale.

Patients were randomized to receive bimekizumab or 56 weeks, or adalimumab for the initial 24 weeks followed by bimekizumab until week 56. The co-primary end points were PASI 90 response (defined as a patient that achieved a 90% reduction from baseline in the PASI score) and IGA response (defined as clear or almost clear with at least a 2-category improvement relative to baseline) at week 16.

Results showed that bimekizumab demonstrated superiority to adalimumab, meeting both co-primary end points at week 16. The study also met all of its ranked secondary end points with statistical significance. Patients treated with bimekizumab achieved superior total skin clearance at weeks 16 and 24, as measured by PASI 100, compared with adalimumab. Additionally, bimekizumab demonstrated statistical superiority to adalimumab in achieving rapid response, defined as PASI 75 at week 4. Patients also maintained high levels of skin clearance with bimekizumab through week 56 during the dose-blind maintenance period.