Bimekizumab shows significant psoriasis skin clearance in phase 3 trial
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Bimekizumab showed evidence of superior skin clearance in patients with plaque psoriasis compared with adalimumab, according to a presentation at the European Academy of Dermatology and Venereology virtual congress.
BE SURE, a phase 3, multicenter, randomized, double-blind, active comparator-controlled trial, randomly assigned 158, 161 and 159 patients with moderate to severe plaque psoriasis to bimekizumab 320 mg every 4 weeks for 56 weeks, bimekizumab 320 mg every 4 weeks for 16 weeks followed by a maintenance period of bimekizumab 320 mg every 8 weeks to week 56, or adalimumab 40 mg every 2 weeks for 24 weeks followed by a maintenance period of bimekizumab 320 mg every 4 weeks to week 56.
Psoriasis Area and Severity Index 90 and Investigator Global Assessment 0/1 was achieved by 86.2% and 85.3% of the bimekizumab group at week 16 compared with 47.2% and 57.2% of the adalimumab group (both P < .001). PASI 100 was achieved by 60.8% of patients treated with bimekizumab compared with 23.9% of those treated with adalimumab (P < .001).
“BE SURE demonstrated that bimekizumab-treated patients achieved significantly higher PASI 90 and PASI 100 skin clearance rates compared to adalimumab at week 16, which were maintained up to 1 year with both 4- and 8-week dosing,” Richard B. Warren, MD, told Healio. “Skin clearance rates rapidly increased in patients who switched from adalimumab to bimekizumab at week 24, with response rates at week 56 comparable to patients treated with bimekizumab throughout the study.”
Treatment emergent adverse events in weeks 0 to 24 were experienced by 71.5% of the bimekizumab cohort and 69.8% of the adalimumab cohort, with serious adverse events being reported in 1.6% and 3.1%, respectively. The most common adverse events included nasopharyngitis, oral candidiasis and upper respiratory tract infection.
“BE SURE is the latest positive phase 3 psoriasis data in bimekizumab’s robust clinical development program. There is a wealth of data in this program, and so far, bimekizumab has been shown to be superior to both ustekinumab and adalimumab,” Warren said. “Detailed results of a phase 3b study — BE RADIANT — comparing bimekizumab to secukinumab are eagerly awaited.”