Potential Psoriasis Breakthrough: Bimekizumab Performs Well in Moderate-to-Severe Plaque Psoriasis

Bimekizumab, an investigational IL-17A and IL-17F inhibitor, is currently under review by the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for the treatment of moderate to severe plaque psoriasis in adults.

Two new Phase 3 studies show that bimekizumab-treated psoriasis patients achieved superior levels of skin clearance compared to those who received placebo or ustekinumab. The safety profile of bimekizumab was consistent with earlier clinical studies with no new safety signals identified, the studies showed.

Published back to back in TheLancet,  BE VIVID and BE READY, two Phase 3 studies evaluating the efficacy and safety profile of bimekizumab, its investigational IL-17A and IL-17F inhibitor, in the treatment of adults with moderate to severe plaque psoriasis, are the first publications from the Phase 3 clinical development program of bimekizumab in psoriasis. 

Data from BE VIVID and BE READY showed that both studies met their co-primary endpoints, demonstrating that bimekizumab-treated patients achieved superior levels of skin clearance, at week 16, compared to those who received placebo or ustekinumab, as measured by at least a 90 percent improvement in the Psoriasis Area and Severity Index (PASI 90) and Investigator’s Global Assessment (IGA) response of clear or almost clear skin (IGA 0/1); p<0.0001 for both comparisons. 

These results were further supported by both studies meeting all ranked secondary endpoints including PASI 100 at week 16, PASI 75 at week 4, PASI 90 at week 52 (BE VIVID) and PASI 90 at week 56 in patients who achieved PASI 90 at week 16 (BE READY). 

Data from the BE VIVID and BE READY studies were included in the marketing application submissions to the FDA and EMA. In September 2020, UCB announced that the Company’s Biologics License Application (BLA) and Marketing Authorization Application (MAA) for bimekizumab for the treatment of moderate to severe plaque psoriasis in adults had been accepted by the FDA and EMA, respectively. 

 The safety and efficacy of bimekizumab have not been established and it is not approved by any regulatory authority worldwide. 

 “This study is a true breakthrough in psoriasis,” says BE VIVID study author Mark Lebwohl, MD, Dean for Clinical Therapeutics and Professor of Dermatology at the Icahn School of Medicine at Mount Sinai in New York City. "This is the first treatment that blocks two related cytokines, IL-17A and IL-17F, to rapidly and effectively clear psoriasis. This study shows that bimekizumab completely clears psoriasis - as measured by achievement of PASI 100, (which shows that all psoriasis is gone) - in a higher proportion of patients than any other therapy we currently have. And because it works by a known mechanism, the expected side effect of bimekizumab would only be yeast infections, and that is exactly what we found, and these were mild to moderate and easily managed.”