Bimekizumab efficacy and safety in patients with moderate to severe plaque psoriasis: two-year interim results from the open-label extension of the randomized BE RADIANT phase 3b trial.

ABSTRACT

BACKGROUND: Bimekizumab is a monoclonal IgG1 antibody that inhibits interleukin (IL)-17A/F. Bimekizumab is more efficacious than secukinumab over one year in the treatment of psoriasis. OBJECTIVE: Evaluate safety and efficacy of bimekizumab through two years in patients with moderate to severe plaque psoriasis. METHODS: The BE RADIANT phase 3b randomized controlled trial consisted of a 48-week double-blinded period, where patients received bimekizumab (320mg every 4 or 8 weeks) or secukinumab (300mg weekly to Week 4, then every 4 weeks), and an open-label extension (OLE). From Week 48, all patients received bimekizumab in the OLE. RESULTS: At Week 48, more patients achieved complete skin clearance (PASI100; modified non-responder imputation) with bimekizumab than secukinumab (74.8% vs 52.8%). PASI100 responses were maintained to Week 96 in continuous bimekizumab patients (70.8%); patients who switched from secukinumab to bimekizumab had increased rates at Week 96 (76.6%). The most common adverse events were nasopharyngitis, oral candidiasis, urinary tract infection. Safety data were consistent with the known safety profile of bimekizumab. LIMITATIONS: Limited racial diversity; overlap with COVID-19 pandemic. CONCLUSIONS: High PASI100 responses achieved with bimekizumab over 48 weeks were sustained through Week 96; secukinumab patients who switched to bimekizumab achieved similar response by Week 96.