Brussels, Belgium and Atlanta, Ga. – August 7th, 2021 – 20:00 CEST/14:00 EST – UCB, a global biopharmaceutical company, announced today new interim data from BE BRIGHT, an open-label extension (OLE) trial to assess the long-term safety, tolerability and efficacy of bimekizumab, an investigational IL-17A and IL-17F inhibitor, in adults with moderate to severe plaque psoriasis.[i],[ii] These results were presented today during a platform presentation at the 2021 American Academy of Dermatology (AAD) Summer Meeting, Tampa, Florida, U.S.
Data presented showed 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).1 The efficacy and safety of bimekizumab have not been established and it is not approved by any regulatory authority worldwide.
“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 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.”
“Given the chronic nature of psoriasis, physicians and patients value treatment options that can offer long-term disease control,” said Emmanuel Caeymaex, Executive Vice President, Immunology Solutions and Head of U.S., UCB. “We are pleased to share the first presentation of bimekizumab data from the BE BRIGHT study highlighting the potential of bimekizumab to provide complete skin clearance that can last through to two years in adult patients with moderate to severe plaque psoriasis.”
Results shared today report on the maintenance of the Investigator’s Global Assessment (IGA) of Clear or Almost Clear skin (IGA 0/1), Body Surface Area (BSA) ≤1%, and Psoriasis Area and Severity Index (PASI) 100 through to two years of bimekizumab treatment.1 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.1
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).1 Similarly, among week 16 BSA ≤1% responders, over 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). Over 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).1
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.[iii],[iv],[v],[vi]
Bimekizumab is currently under review by the U.S. Food and Drug Administration (FDA) for the treatment of moderate to severe plaque psoriasis in adults. On June 25th, 2021, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending granting a marketing authorization for bimekizumab for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy. The final decision of the European Commission on marketing authorization is expected within approximately two months of the CHMP opinion.