Year: 2026
Type: article
Study design: Clinical Trial
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.
Source: JAMA Dermatology
Institutions: University Medical Center Hamburg-Eppendorf, Wake Forest University Health Sciences, Wake Forest University, Manchester Academic Health Science Centre, University of Manchester, NIHR Manchester Biomedical Research Centre, Northern Care Alliance NHS Foundation Trust, University of California, Los Angeles, Dermatrials Research, Hospital de Sant Pau, National Psoriasis Foundation, UCB Pharma (France), UCB Pharma (Germany), UCB Pharma (United Kingdom), The University of Texas Southwestern Medical Center
Language: English
Subfield: Immunology
Field: Immunology and Microbiology
Domain: Life Sciences
Open Access status: hybrid
Awards: G1483213741, G1798610363
OpenAlex ID: W7130439134
