Bimekizumab Efficacy in Patients with Moderate to Severe Plaque Psoriasis and Hypertension, Elevated Body Mass Index, or Hyperglycemia: Results Through 3 years of Treatment in 5 Phase 3/3b Trials

Abstract

Introduction: Patients with moderate to severe plaque psoriasis have a higher risk of cardiometabolic comorbidities than the general population.^1,2 Here, response to bimekizumab (BKZ) in psoriasis patients with hypertension, elevated body mass index (BMI), or hyperglycemia at baseline is reported through 3 years of treatment.

Procedure/study: Data were pooled from the following trials: BE SURE, BE VIVID, BE READY, their open-label extension (OLE) BE BRIGHT, and BE RADIANT.^3–7 Included patients received BKZ 320 mg every 4 weeks (Q4W) to Week 16, then Q4W or Q8W in the maintenance period and on OLE entry. All received BKZ Q8W from Week 64 (BE RADIANT)/OLE Week 48 (BE BRIGHT) or next scheduled visit (dose groups were combined in this analysis). Psoriasis Area and Severity Index (PASI) ≤2, ≥90% improvement from baseline in PASI (PASI 90), and PASI 100 responses were evaluated in patients with psoriasis and concurrent hypertension (systolic >130 mmHg or diastolic >85 mmHg), elevated BMI (>30 kg/m²), or hyperglycemia (≥140 mg/dL or ≥7.8 mmol/L), based on objective laboratory measurements at baseline. Data are reported using modified non-responder imputation: patients who discontinued due to lack of efficacy or treatment-related adverse events were considered non-responders at subsequent timepoints; multiple imputation was used for all other missing data.

Results: Of 1,107 BKZ-randomized patients who entered the OLEs, 546, 493, and 81 had hypertension, elevated BMI, and hyperglycemia at baseline, respectively. At Week 16, 91.3% of all BKZ-treated patients had PASI ≤2; high response rates were also observed in patients with hypertension (88.9%), elevated BMI (87.8%), and hyperglycemia (87.7%). At Year 3 (OLE Week 96), PASI ≤2 response rates were 91.3% (all patients), 90.0% (hypertension), 89.4% (elevated BMI), and 91.1% (hyperglycemia). At Week 16, 90.9%/65.5% of all BKZ-treated patients achieved PASI 90/100; high responses were also observed in patients with hypertension (89.0%/62.8%), elevated BMI (87.6%/60.3%), and hyperglycemia (86.4%/64.2%). At Year 3, PASI 90/100 response rates were 90.7%/70.0% (all patients), 89.3%/66.3% (hypertension), 89.2%/66.2% (elevated BMI), and 87.9%/57.7% (hyperglycemia).

Conclusion: High levels of complete/near-complete skin clearance achieved at Week 16 were durable through 3 years’ BKZ treatment in psoriasis patients, including those who had baseline hypertension, elevated BMI, or hyperglycemia.

Funding: UCB Pharma.