Abstract
IMPORTANCE: Patient-reported outcome (PRO) assessments alongside clinical parameters help to holistically determine treatment benefits. OBJECTIVE: To assess PROs among bimekizumab-treated patients with moderate to severe plaque psoriasis. DESIGN, SETTING, AND PARTICIPANTS: The BE RADIANT multicenter, phase 3b randomized clinical trial and open-label extension (OLE) had a 48-week double-blinded period and 96-week OLE (3 years' total treatment). Patients initially received bimekizumab or secukinumab. At year 1 (week 48/OLE entry), bimekizumab-randomized patients continued bimekizumab treatment (continuous bimekizumab-treated patients) and secukinumab-randomized patients switched to bimekizumab (secukinumab/bimekizumab-treated patients). INTERVENTIONS: Continuous bimekizumab-treated patients received bimekizumab, 320 mg, every 4 weeks to week 16, then every 4 weeks or every 8 weeks to 1 year and into the OLE. Secukinumab/bimekizumab-treated patients received secukinumab, 300 mg, every 4 weeks to 1 year, then switched to bimekizumab, 320 mg, every 4 weeks or every 8 weeks. All received bimekizumab every 8 weeks by week 64. MAIN OUTCOMES AND MEASURES: Patient-reported itching/skin pain/scaling (Psoriasis Symptoms and Impacts Measure [P-SIM]) and concurrent achievement of Psoriasis Area and Severity Index (PASI) and Dermatology Life Quality Index (DLQI) scores are reported (nonresponder imputation to 1 year; modified nonresponder imputation to 1-3 years). RESULTS: A total of 373 bimekizumab-treated and 370 secukinumab-treated patients were randomized at baseline; 336 and 318, respectively, entered the OLE. Among bimekizumab-randomized and secukinumab-randomized patients, 127 (34.0%) and 93 (25.1%) reported no itching; 278 (74.5%) and 222 (60.0%) no skin pain; and 172 (46.1%) and 80 (21.6%) no scaling at week 4, respectively; at year 1, rates remained higher in bimekizumab-randomized vs secukinumab-randomized patients (itching: 227 [60.9%] vs 178 [48.1%]; nominal P < .001; skin pain: 293 [78.6%] vs 262 [70.8%]; nominal P = .01; scaling: 263 [70.5%] vs 184 [49.7%]; nominal P < .001). Bimekizumab-randomized patients had greater concurrent achievement rates of PASI = 0 and DLQI 0/1 vs secukinumab-randomized patients (week 4: 43 [11.5%] vs 17 [4.6%]; nominal P < .001; year 1: 230 [61.7%] vs 158 [42.7%]; nominal P < .001). In patients entering the OLE, high P-SIM = 0 rates were maintained to year 3. At OLE entry, concurrent achievement of PASI = 0 and DLQI 0/1 was reported in 69.2% continuous bimekizumab-treated and 48.5% secukinumab/bimekizumab-treated patients. After switching, secukinumab/bimekizumab responses increased, and high rates were maintained to year 3 for both continuous bimekizumab and secukinumab/bimekizumab (62.2% and 63.8%, respectively). CONCLUSIONS AND RELEVANCE: In this randomized clinical trial and OLE, bimekizumab rapidly and durably improved symptoms/health-related quality of life to 3 years, demonstrating that clinical efficacy translates to quality of life improvements. Secukinumab-randomized patients reported improvements on switching to bimekizumab. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT03536884.