In phase 3b data presented at the American Academy of Dermatology (AAD) Virtual Meeting Experience (VMX) 2021 showed bimekizumab achieved superior levels of complete skin clearance compared to secukinumab for psoriasis.
UCB, a global biopharmaceutical company, announced today that The New England Journal of Medicine has published two manuscripts with results from BE RADIANT and BE SURE, 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. Results from the Phase 3b BE RADIANT study were also shared today as a late-breaking oral presentation at the American Academy of Dermatology Virtual Meeting Experience 2021. BE RADIANT is the first Phase 3 study to compare the efficacy and safety of dual IL-17A and IL-17F inhibition versus IL-17A inhibition alone.
“The publication of data from BE RADIANT and BE SURE in The New England Journal of Medicine underscores the significance of these studies to the medical community, and closely follows the publication of the first two bimekizumab Phase 3 studies in The Lancet earlier this year,” said Emmanuel Caeymaex, executive vice president, Immunology Solutions and head of U.S., UCB. “Results published today reflect the high rates of complete skin clearance, PASI 100, at Week 16, rapid response after one dose and durability of response up to one year seen with bimekizumab in previous studies.”
The safety and efficacy of bimekizumab have not been established and it is not approved by any regulatory authority worldwide.
BE RADIANT Results
The Phase 3b BE RADIANT study compared the efficacy and safety of bimekizumab to secukinumab in adults with moderate to severe plaque psoriasis.1 The study met its primary endpoint, with significantly more patients treated with bimekizumab achieving complete skin clearance, as measured by a 100% improvement from baseline in the Psoriasis Area and Severity Index (PASI 100) at Week 16, compared to those treated with secukinumab (61.7% versus 48.9%, respectively; p<0.001).
The study also met all ranked secondary endpoints. The superior levels of complete skin clearance observed at Week 16 continued through to Week 48, with 67% of patients treated with bimekizumab, achieving PASI 100, compared to 46.2% of patients treated with secukinumab (p<0.001). At Week 48, both bimekizumab maintenance dosing groups (every 4 weeks [Q4W] and every eight weeks [Q8W]), showed higher rates of complete skin clearance (PASI 100), compared with secukinumab (p<0.001). In addition, at Week 4, significantly more patients treated with bimekizumab achieved PASI 75 compared to patients treated with secukinumab (71% versus 47.3%, respectively; p<0.001).
“In BE RADIANT, patients treated with bimekizumab achieved superior levels of complete skin clearance, PASI 100, compared with secukinumab-treated patients at Week 16, the primary endpoint of the study, and up to 48 weeks of therapy. At Week 4, a faster onset of response was also observed with bimekizumab compared with secukinumab. Data from this study support the value of inhibition of IL-17F in addition to IL-17A in the treatment of patients with moderate to severe plaque psoriasis,” said Kristian Reich, MD, PhD, Translational Research in Inflammatory Skin Diseases, Institute for Health Services Research in Dermatology and Nursing, University Medical Center Hamburg-Eppendorf, Germany.
Across the study duration, the most common treatment-emergent adverse events (TEAEs) with bimekizumab were upper respiratory tract infections (38.9), oral candidiasis (19.3%) and urinary tract infection (6.7%). Oral candidiasis cases were predominantly mild or moderate and none led to discontinuation. Over 48 weeks, the incidence of serious TEAEs was 5.9% with bimekizumab and 5.7% with secukinumab.
Bimekizumab is an investigational humanized monoclonal IgG1 antibody that selectively and directly inhibits both IL-17A and IL-17F, two key cytokines driving inflammatory processes. IL-17F has overlapping biology with IL-17A and drives inflammation independently of IL-17A. Selective inhibition of IL-17F in addition to IL-17A suppresses inflammation to a greater extent than IL-17A inhibition alone. The safety and efficacy of bimekizumab are being evaluated across multiple disease states as part of a robust clinical program.
About the BE RADIANT study
BE RADIANT is a Phase 3b, randomized, multicenter, double-blind, active comparator-controlled, parallel-group study designed to assess the efficacy and safety of bimekizumab compared to secukinumab in adult subjects with moderate to severe chronic plaque psoriasis. BE RADIANT enrolled 743 participants with psoriasis for at least six months prior to the screening, a baseline PASI score ≥12, body surface area [BSA] affected by psoriasis ≥10% and IGA score ≥3.20
Patients were randomized to bimekizumab (320 mg every Q4W) or secukinumab (300 mg weekly to Week 4 and then Q4W).3 From Week 16, bimekizumab-randomized patients received treatment dosed Q4W or every 8 weeks (Q8W). The primary endpoint was PASI 100 response at Week 16. Key secondary endpoints included PASI 100 at Week 48 and PASI 75 at Week 4.1 Following the 48-week double-blinded period, patients were able to enroll in an ongoing 96-week open-label extension.
UCB announced top-line findings from BE RADIANT in July 2020.