Open-label Extension Study Shows Long-term Safety, Efficacy for UCB's Bimekizumab in PsO

New interim data from an open-label extension trial to assess the long-term safety, tolerability, and efficacy of bimekizumab show that the majority of patients who achieved complete or near complete skin clearance after 16 weeks of bimekizumab treatment maintained these responses through to two years with continuous maintenance dosing, every four weeks (Q4W) or every eight weeks (Q8W).

Results from the BE BRIGHT study of bimekizumab, an investigational IL-17A and IL-17F inhibitor under FDA review for the treatment of adults with moderate to severe plaque psoriasis, were presented at the 2021 American Academy of Dermatology (AAD) Summer Meeting in Tampa, FL. The drug is being developed by UCB.

“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,” says Mark Lebwohl, MD, in a statement. Dr. Lebwohl is Dean for Clinical Therapeutics, Icahn School of Medicine at Mount Sinai, and Chairman emeritus, Kimberly and Eric J. Waldman Department of Dermatology and Presenting Author of the data at the AAD Summer Meeting. “These data are meaningful for the dermatology community and further add to the clinical evidence we have from the bimekizumab Phase 3 clinical program.”

Analyses included patients randomized to bimekizumab 320 mg Q4W who exhibited a response at week 16 in one of the pivotal Phase 3 studies (BE READY, BE VIVID, BE SURE), received bimekizumab 320 mg Q4W or Q8W maintenance dosing from week 16, and continued with the same maintenance dosing in the open-label BE BRIGHT study, i.e., Q4W/Q4W/Q4W or Q4W/Q8W/Q8W.

Initially, 989 patients were randomized to bimekizumab Q4W. At week 16, 87.5 percent achieved IGA 0/1, 74.9 percent achieved BSA ≤1% and 62.7 percent achieved PASI 100. Among week 16 IGA 0/1 responders, over nine out of 10 patients maintained IGA 0/1 to week 48 in the OLE trial (94.4 and 96.2 percent with continuous Q4W and Q8W maintenance dosing, respectively). Similarly, among week 16 BSA ≤1% responders, more than nine out of 10 patients maintained BSA ≤1% to week 48 in the OLE trial (90.7 and 92.5 percent with continuous Q4W and Q8W maintenance dosing, respectively). More than eight out of 10 patients who achieved complete skin clearance (PASI 100) at week 16 maintained response to week 48 in the OLE trial (80.7 and 86.1 percent with continuous Q4W and Q8W maintenance dosing, respectively).

In BE READY, BE VIVID and BE SURE, the most frequently reported treatment-emergent adverse events in bimekizumab-treated patients were nasopharyngitis, oral candidiasis, and upper respiratory tract infection.