Bimekizumab Demonstrates Positive Long-term in Phase 3 Psoriasis Trial

UCB announced new interim data from BE BRIGHT (NCT03598790), an open-label extension trial to assess the long-term efficacy, safety, and tolerability of bimekizumab in adults with moderate to severe plaque psoriasis, the results of which were presented at the 2021 American Academy of Dermatology (AAD) Summer Meeting, Tampa, Florida^.1

Bimekizumab is an investigational humanized monoclonal immunoglobulin (Ig)G1 antibody that selectively inhibits interleukin (IL)-17A and IL-17F, both of which are two key cytokines driving inflammatory processes.

The BE BRIGHT trial’s report shared the maintenance of the Investigator Global Assessment (IGA) 0/1 clear or almost clear skin, Body Surface Area (BSA) of less than or equal to 1%, and Psoriasis Area and Severity Index (PASI) 100 through 2 years of bimekizumab treatment. 

The analysis included patients randomized to bimekizumab 320 mg every 4 weeks who showed a response at week 16 in 1 of the other phase 3 studies—BE READY, BE SURE, BE VIVID—that also were treated with bimekizumab 320 mg every 4 or 8 weeks as a maintenance dose after week 16 and continued the regimen in the BE BRIGHT trial.

There were 989 patients randomized to bimekizumab every 4 weeks and at week 16, 87.5% achieved IGO 0/1, 74.9% achieved BSA of less than or equal to 1 %, and 62.7% achieved PASI 100. 

Of the week 16 patients who achieved IGA 0/1, 94.4% of those dosed every 4 weeks and 96.2% of those dosed every 8 weeks maintained the response to week 48. 

For the BSA responders, 90.7% and 92.5% maintained BSA less than or equal to 1% to week 48 from week 16 for the 4-week and 8-week dose respectively. Also, more than 80% of patients who achieved PASI 100 at week 16 maintained response to week 48 in both groups.

“These interim results from the BE BRIGHT study highlight the potential of bimekizumab to provide lasting skin clearance to adults living with moderate to severe plaque psoriasis,” said Mark Lebwohl, MD, dean for clinical therapeutics, Icahn School of Medicine at Mount Sinai, and chairman emeritus, Kimberly and Eric J. Waldman Department of Dermatology and member of Dermatology Times’® editorial advisory board. “These data are meaningful for the dermatology community and further add to the clinical evidence we have from the bimekizumab phase 3 clinical program.”

The FDA plans to decide on approval for the drug on October 15, 2021.

Reference:

1. UCB. New two-year data showed bimekizumab maintained high levels of skin clearance in patients with moderate to severe plaque psoriasis. Published August 7, 2021. Accessed August 10, 2021. https://www.prnewswire.com/news-releases/new-two-year-data-showed-bimekizumab-maintained-high-levels-of-skin-clearance-in-patients-with-moderate-to-severe-plaque-psoriasis-301350503.html