Bimekizumab Efficacy and Safety in Japanese Patients with Plaque Psoriasis in BE VIVID: A Phase 3, Ustekinumab and Placebo-Controlled Study

Abstract

Introduction: Bimekizumab treatment resulted in improved clinical outcomes in patients with moderate-to-severe plaque psoriasis in BE VIVID, a 52-week, phase 3, randomized, ustekinumab and placebo-controlled study. We present data from the BE VIVID Japan patient subpopulation.

Methods: Globally, patients were randomized to receive bimekizumab 320 mg every 4 weeks (Q4W), ustekinumab (45/90 mg weight-based at baseline and week 4, then every 12 weeks), or placebo (Q4W through week 16, then bimekizumab 320 mg Q4W). Efficacy endpoints included week 16 Psoriasis Area and Severity Index (PASI) 90 and Investigator's Global Assessment (IGA) 0/1, and other outcomes [PASI 100, PASI 75, IGA 0, Dermatology Life Quality Index (DLQI) 0/1, absolute PASI, scalp IGA, Psoriasis Symptoms and Impacts Measure (P-SIM) responses]. Safety analyses were conducted.

Results: There were 108 Japanese randomized patients (bimekizumab: 62; ustekinumab: 29; placebo: 17). At week 16, bimekizumab-treated patients had a higher clinical response versus ustekinumab and placebo (PASI 90: 85.5% versus 51.7% and 5.9%; IGA 0/1: 82.3% versus 48.3% and 0.0%). Over 52 weeks, improved clinical response was maintained with bimekizumab, including patients switching from placebo at week 16. Overall, the safety profile in Japanese patients was consistent with that observed in the global population.

Conclusion: Bimekizumab resulted in improved clinical response versus ustekinumab and placebo, and was well-tolerated in Japanese patients.

Trial registration: NCT03370133.

Keywords: Absolute PASI; Active control; Bimekizumab; Japan subpopulation; Plaque psoriasis; Randomized controlled trial; Ustekinumab.

© 2023. The Author(s).

Figures

Fig. 1

Japanese patient subpopulation trial profile. The n numbers at weeks 16 and 52 represent the number of patients in each treatment arm who completed the study up to that time, and whose data were considered for inclusion in the analysis. aPatients were switched from placebo to bimekizumab 320 mg Q4W at week 16. Q4W: every 4 weeks

Fig. 2

Week 16 efficacy in the Japan patient subpopulation. a PASI 90 response; b IGA 0/1 response; c PASI 100 response; d IGA score of 0; e DLQI 0/1 response. DLQI 0/1 Dermatology Life Quality Index score of 0 or 1, indicating “no effect of psoriasis on patient’s life,” IGA 0/1 Investigator’s Global Assessment score of 0 (clear) or 1 (almost clear) with ≥ 2 category improvement relative to baseline in Investigator's Global Assessment, scored on a 5-point scale, NRI nonresponder imputation, OC observed case, PASI XX ≥ XX% improvement from baseline in Psoriasis Area and Severity Index score, Pts patients, Q4W every 4 weeks

Fig. 3

Efficacy over time (week 0–52) in the Japan patient subpopulation (NRI). a PASI 90 response; b IGA 0/1 response; c PASI 100 response; d IGA 0 response; e PASI 75 response; f DLQI 0/1 response; g PASI ≤ 1 response; h PASI ≤ 2 response; i PASI ≤ 3 response. At week 16, patients receiving placebo were switched to bimekizumab 320 mg Q4W. Missing data imputed by nonresponse. DLQI 0/1 Dermatology Life Quality Index score of 0 or 1, indicating “no effect of psoriasis on patient’s life,” IGA 0/1 Investigator's Global Assessment score of 0 (clear) or 1 (almost clear), with ≥ 2 category improvement relative to baseline in Investigator's Global Assessment, scored on a 5-point scale, NRI nonresponder imputation, PASI ≤ X absolute Psoriasis Area and Severity Index of ≤ X, PASI XX ≥ XX% improvement in Psoriasis Area and Severity Index score, Pts patients, Q4W every 4 weeks