Bimekizumab maintenance of response through three years in patients with moderate to severe plaque psoriasis: Results from the BE BRIGHT open-label extension trial

Abstract Background Given the chronic nature of psoriasis and the loss of response that can be observed with therapies over time, it is important to understand the long-;term efficacy of new treatments. Objective To evaluate maintenance of Week 16 responses with bimekizumab treatment through Year 3, in patients with moderate to severe plaque psoriasis. Methods Data were pooled from bimekizumab-treated patients in the 52-week (BE VIVID) and 56-week (BE READY and BE SURE) phase 3 studies, and their ongoing open-label extension (OLE), BE BRIGHT. Efficacy outcomes are reported through three years of bimekizumab treatment in patients with an efficacy response at Week 16. Missing data were imputed primarily using modified non-responder imputation (mNRI), with non-responder imputation and observed case data also reported. Results A total of 989 patients were randomized to bimekizumab at baseline in BE VIVID, BE READY, and BE SURE. At Week 16, 693 patients achieved ≥90% reduction from baseline in Psoriasis Area and Severity Index (PASI 90), 503 achieved 100% reduction from baseline in PASI (PASI 100), 694 achieved absolute PASI ≤2, and 597 achieved body surface area (BSA) ≤1%, and continued into the OLE. Of these, 93.0% maintained PASI 90, 80.8% maintained PASI 100, 94.0% maintained PASI ≤2, and 90.3% maintained BSA ≤1% responses through to three years of bimekizumab treatment (mNRI). Among Week 16 PASI 90 responders, 96.8% and 72.5% also achieved Investigator’s Global Assessment (IGA) 0/1 and PASI 100 at Week 16, respectively, and 92.2% and 73.4% achieved these responses at Year 3 (mNRI). Among Week 16 PASI 100 responders, 76.3% also achieved Dermatology Life Quality Index (DLQI) 0/1 at Week 16, and DLQI 0/1 response increased with continuous bimekizumab treatment to 89.0% at Year 3 (mNRI). Conclusions High levels of clinical response were maintained through to three years of bimekizumab treatment in the vast majority of Week 16 responders. Long-term treatment with bimekizumab was efficacious, with important benefits on health-related quality of life (HRQoL), in patients with moderate to severe plaque psoriasis.