Bimekizumab Efficacy in Psoriasis by Subgroups: Post Hoc Analysis of Phase 3/3b Clinical Trials

Abstract

Introduction: Patient demographics, disease characteristics, and treatment history can impact the efficacy of biologic treatments in patients with psoriasis. Understanding the efficacy of biologics, such as bimekizumab, across diverse patient subgroups is important for optimising treatment outcomes. Here, we assess whether high overall clinical responses observed in bimekizumab-treated patients with moderate to severe plaque psoriasis are consistent across subgroups, both versus comparators and with long-term treatment.

Methods: Data were analysed post hoc from the BE SURE, BE VIVID, and BE READY phase 3 trials, their open-label extension (OLE) BE BRIGHT, and the BE RADIANT phase 3b trial. Patients received either bimekizumab or adalimumab to week 24 (BE SURE), bimekizumab or ustekinumab to week 52 (BE VIVID), and bimekizumab or secukinumab to week 48 (BE RADIANT). In the 3-year pooled analysis (all trials), included patients received bimekizumab continuously from baseline into the OLE. Subgroups of patients with moderate to severe plaque psoriasis were defined by age, sex, weight, disease duration, disease severity, nail involvement (modified Nail Psoriasis Severity Index > 0), and prior biologic exposure, at baseline. The proportions of patients achieving complete skin clearance (PASI 100; 100% improvement from baseline in Psoriasis Area and Severity Index) in each subgroup are reported alongside 95% confidence intervals (CI). Modified non-responder imputation (mNRI) was used for missing data.

Results: Following comparator-controlled periods, the proportion of bimekizumab-treated patients who achieved PASI 100 was consistent across subgroups and numerically greater versus patients who received adalimumab (to week 24), ustekinumab (to week 52), and secukinumab (to week 48) in all subgroups. Among patients who received bimekizumab continuously for 3 years (N = 1107), PASI 100 response rates remained consistent across age (68.6% [40 to < 65 years]-73.7% [≥ 65 years]), sex (69.6% [male]-71.4% [female]), weight (63.4% [≥ 103.9 kg]-75.5% [< 74.3 kg]), disease duration (65.5% [≤ 5 years]-71.1% [> 20 years]), disease severity (67.7% [PASI 12 to < 15]-71.1% [PASI ≥ 20]), nail involvement (69.1% [yes]/71.3% [no]), and prior biologic exposure (71.7% [yes]/69.1% [no]; prior anti-TNF exposure 67.6% [yes]/70.6% [no]) subgroups; 95% CIs overlapped in all instances, indicating no meaningful differences between subgroups.

Conclusion: Bimekizumab demonstrated consistently high long-term efficacy in patients with psoriasis across diverse subgroups. Higher rates of PASI 100 were achieved with bimekizumab versus adalimumab, ustekinumab, and secukinumab, across all subgroups. These results highlight bimekizumab as an effective treatment for a broad range of people living with psoriasis.

Trial registration: NCT03412747, NCT03370133, NCT03410992, NCT03598790, NCT03536884.

Keywords: Bimekizumab; Demographics; Disease characteristics; Efficacy; Post hoc; Psoriasis; Subgroup; Treatment history.

Fig. 1

PASI 100 response rates in bimekizumab- versus adalimumab-treated patients by subgroup at week 24 (mNRI). Error bars represent 95% CIs. Nail involvement refers to patients with an mNAPSI score > 0. BMI body mass index, BKZ bimekizumab, CI confidence interval, mNAPSI modified Nail Psoriasis Severity Index, mNRI modified non-responder imputation, N number of patients in subgroup, PASI Psoriasis Area and Severity Index, PASI 100 100% improvement from baseline in PASI, Q quartile, TNF tumour necrosis factor. ^a95% CIs were not estimable because of low patient numbers

Fig. 2

PASI 100 response rates in bimekizumab- versus ustekinumab-treated patients by subgroup at week 52 (mNRI). Error bars represent 95% CIs. Nail involvement refers to patients with an mNAPSI score > 0. Ustekinumab dosing varied depending on patient weight (45 mg: patients weighing ≤ 100 kg, 90 mg: patients weighing > 100 kg) [34]. BKZ bimekizumab, BMI body mass index, CI confidence interval, mNAPSI modified Nail Psoriasis Severity Index, mNRI modified non-responder imputation, N number of patients in subgroup, PASI Psoriasis Area and Severity Index, PASI 100 100% improvement from baseline in PASI, Q quartile, TNF tumour necrosis factor

Fig. 3

PASI 100 response rates in bimekizumab- versus secukinumab-treated patients by subgroup at week 48 (mNRI). Error bars represent 95% CIs. Nail involvement refers to patients with an mNAPSI score > 0. BKZ bimekizumab, BMI body mass index, CI confidence interval, mNAPSI modified Nail Psoriasis Severity Index, mNRI modified non-responder imputation, N number of patients in subgroup, PASI Psoriasis Area and Severity Index, PASI 100 100% improvement from baseline in PASI, Q quartile, TNF tumour necrosis factor

Fig. 4

PASI 100 response rates in bimekizumab-treated patients by subgroup at year 3 (mNRI). Error bars represent 95% CIs. Nail involvement refers to patients with an mNAPSI score > 0. BKZ bimekizumab, BMI body mass index, CI confidence interval, mNAPSI modified Nail Psoriasis Severity Index, mNRI modified non-responder imputation, N number of patients in subgroup, PASI Psoriasis Area and Severity Index, PASI 100 100% improvement from baseline in PASI, Q quartile, Q4W every 4 weeks, Q8W every 8 weeks, TNF tumour necrosis factor