Synopsis Conclusions Bimekizumab demonstrated greater skin clearance that was durable in patients with moderate to severe plaque psoriasis as compared with ustekinumab, regardless of patient subgroup. These results support bimekizumab as a psoriasis treatment suitable for a wide variety of patients given its consistent efficacy across all subgroups analyzed. Objective To assess the efficacy of bimekizumab compared with ustekinumab over 52 weeks of treatment across demographic, disease characteristic, and prior treatment history subgroups of patients with moderate to severe plaque psoriasis from the BE VIVID study. Background • Bimekizumab is a monoclonal IgG1 antibody that selectively inhibits IL-17F in addition to IL-17A, both of which play a pivotal role in the pathogenesis of psoriasis (PSO).1–4 • Given that the severity of PSO can vary with age, weight and prior treatment exposure,5 there is a need for therapies that provide consistent and durable skin clearance, regardless of patient/disease characteristics and treatment history. Methods • In BE VIVID (NCT03370133), patients were randomized to receive bimekizumab through Week 52, ustekinumab through Week 52, or placebo to Week 16 followed by bimekizumab (patients randomized to placebo were not included in these analyses; Figure 1). • Subgroup analyses were conducted based on patient demographics, disease characteristics, and prior treatment exposure. • Proportions of bimekizumab- versus ustekinumab-treated patients achieving 90% and 100% improvement from baseline Psoriasis Area and Severity Index (PASI 90 and PASI 100) were calculated at Weeks 16 and 52. Missing data were imputed as non-response (NRI). Results Patient Population • Baseline characteristics for patients randomized to bimekizumab or ustekinumab are shown in Table 1. Bimekizumab Efficacy Across Subgroups • PASI 90 (Figure 2) and PASI 100 (Figure 3) response rates were greater in patients randomized to bimekizumab compared with ustekinumab across all subgroups at Week 16. • Responses were further improved or maintained in bimekizumab-treated patients through Week 52 and remained higher than responses in patients receiving ustekinumab (Figure 2 and Figure 3). B. Strober,1,2 J.G. Krueger,3 N. Magnolo,4 R. Vender,5 D.P. Toth,6 D. Thaçi,7 M. Wang,8 C. Cioffi,8 C. Madden,8 R.B. Warren9 BSA: body surface area; DLQI: Dermatology Life Quality Index; IGA: Investigator’s Global Assessment; IL: interleukin; IMP: investigational medicinal product; ITT: intention-to-treat; NRI: non-responder imputation; PASI: Psoriasis Area and Severity Index; Q4W: every 4 weeks; Q12W: every 12 weeks; SD: standard deviation; TNF: tumor necrosis factor. Figure 1 Study design Bimekizumab 320 mg Q4W (n=321) Ustekinumab 45/90 mg Q12Wb (n=163) Age (years), mean ± SD 45.2 ± 14.0 46.0 ± 13.6 <40 years, n (%) 123 (38.3) 57 (35.0) 40–<65 years, n (%) 164 (51.1) 88 (54.0) ≥65 years, n (%) 34 (10.6) 18 (11.0) Male, n (%) 229 (71.3) 117 (71.8) Caucasian, n (%) 237 (73.8) 120 (73.6) Weight (kg), mean ± SD 88.7 ± 23.1 87.2 ± 21.1 ≤100 kg, n (%) 226 (70.4) 122 (74.8) >100 kg, n (%) 95 (29.6) 41 (25.2) Duration of psoriasis (years), mean ± SD 16.0 ± 11.6 17.8 ± 11.6 100 kg at baseline received two ustekinumab 45 mg injections (90 mg total). Table 1 Baseline characteristicsa aPatients randomized to placebo are not shown here; bUstekinumab dosing was based on weight: patients ≤100 kg at baseline received one ustekinumab 45 mg injection and one placebo injection, patients >100 kg at baseline received two ustekinumab 45 mg injections (90 mg total); cIn each treatment group, one patient with IGA=2 was mistakenly enrolled. Figure 2 Achievement of PASI 90 at Weeks 16 and 52 (ITT, NRI) A) Week 16 Bimekizumab demonstrated greater skin clearance vs ustekinumab, regardless of patient subgroup. Bimekizumab vs Subgroup Analyses: Figure 3 Achievement of PASI 100 at Weeks 16 and 52 (ITT, NRI) B) Week 52 aIn each treatment group, one patient with IGA=2 was mistakenly enrolled and is not shown here. A) Week 16 B) Week 52 aIn each treatment group, one patient with IGA=2 was mistakenly enrolled and is not shown here. Disease characteristics • Duration (100 kg) Bimekizumab Ustekinumab Bimekizumab 81.9% Ustekinumab 55.8% Age (years) ≥65 Baseline weight (kg) 40–<65 <40 ≤100 >100 Psoriasis disease duration 100 Psoriasis disease duration 100 Psoriasis disease duration 100 Psoriasis disease duration