Bimekizumab Complete Clearance of Both Skin and Nail Psoriasis: Comparative Efficacy in Phase III/IIIb Studies.

Abstract

Background: Nail psoriasis can have a substantial negative impact on both the physical and emotional well-being of patients, and is a risk factor for psoriatic arthritis. Achieving complete clearance of nails in addition to skin is therefore an important treatment goal.

Objectives: We aimed to evaluate concurrent complete skin and nail clearance in patients with moderate-to-severe plaque psoriasis treated with bimekizumab or active comparators.

Methods: Data were analyzed from the BE SURE and BE VIVID phase III trials, their open-label extension BE BRIGHT, and the BE RADIANT phase IIIb trial and its open-label extension. Included patients had baseline modified Nail Psoriasis Severity Index (mNAPSI) >0 and entered their respective open-label extension. Proportions of patients achieving complete skin (PASI 100; 100% improvement from baseline in Psoriasis Area and Severity Index) and nail (mNAPSI 0) clearance at the same time are reported for bimekizumab- and active comparator-treated patients during controlled trial periods, and in the long term for continuous bimekizumab-treated patients and those switching from comparators. Data are reported using modified non-responder imputation.

Results: At the end of comparator-controlled periods, 45.8% of bimekizumab (N = 151) versus 18.3% of adalimumab (N = 91) patients (BE SURE week 24), 51.1% of bimekizumab (N = 169) versus 26.5% of ustekinumab (N = 92) patients (BE VIVID week 52), and 63.3% of bimekizumab (N = 182) versus 36.1% of secukinumab (N = 155) patients (BE RADIANT week 48) achieved PASI 100 and mNAPSI 0. Following long-term treatment, 57.7% of adalimumab switchers/49.1% of continuous bimekizumab patients (BE SURE/BE BRIGHT year 4), 52.2% of ustekinumab switchers/48.3% of continuous bimekizumab patients (BE VIVID/BE BRIGHT year 4), and 51.9% of secukinumab switchers/57.4% of continuous bimekizumab patients (BE RADIANT year 3) achieved PASI 100 and mNAPSI 0.

Conclusions: Numerically higher proportions of bimekizumab-treated patients achieved concurrent complete skin and nail clearance versus adalimumab, ustekinumab, and secukinumab. Clearance rates increased following switch to bimekizumab, and were sustained long-term in both switchers to bimekizumab and continuous bimekizumab-treated patients. [Graphical abstract available.] CLINICAL TRIAL REGISTRATION: NCT03412747, NCT03370133, NCT03598790, NCT03536884.