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.