Certolizumab pegol for the treatment of patients with moderate‐to‐severe chronic plaque psoriasis: pooled analysis of week 16 data from three randomized controlled trials

• Published in: Journal of the European Academy of Dermatology and Venereology 2019-03, Vol.33 (3), p.546-552
• Main Authors: Blauvelt, A., Reich, K., Lebwohl, M., Burge, D., Arendt, C., Peterson, L., Drew, J., Rolleri, R., Gottlieb, A.B.
• Format: Article
• Language: English
• Subjects: Adult; Certolizumab Pegol - administration & dosage; Certolizumab Pegol - adverse effects; Certolizumab Pegol - therapeutic use; Clinical Trials, Phase III as Topic; Dermatologic Agents - administration & dosage; Dermatologic Agents - adverse effects; Dermatologic Agents - therapeutic use; Double-Blind Method; Female; Humans; Male; Middle Aged; Psoriasis; Psoriasis - drug therapy; Quality of Life; Randomized Controlled Trials as Topic; Severity of Illness Index; Short Report
• ISSN: 0926-9959; 1468-3083; 1468-3083
• DOI: 10.1111/jdv.15258

Background Certolizumab pegol, an Fc‐free, PEGylated, anti‐tumour necrosis factor (TNF) biologic, has demonstrated favourable results in three ongoing, phase 3, randomized, double‐blinded, placebo‐controlled trials in adults with psoriasis. Objective Data were pooled from the ongoing trials to investigate efficacy in selected subgroups and add precision to estimates of treatment effects during the initial 16 weeks of treatment. Methods In each trial, patients ≥18 years with moderate‐to‐severe chronic plaque psoriasis for ≥6 months were randomized to receive certolizumab 400 mg, certolizumab 200 mg or placebo every 2 weeks for 16 weeks. Coprimary endpoints for the pooled analysis were responder rates at Week 16, defined as ≥75% reduction in psoriasis area and severity index (PASI 75) and physician global assessment (PGA) of 0/1 (‘clear’/‘almost clear’ with ≥2‐category improvement). Safety was assessed by treatment‐emergent adverse events. Results A total of 850 patients treated with certolizumab 400 mg (N = 342), certolizumab 200 mg (N = 351) or placebo (N = 157) were included in the pooled analysis. At Week 16, PASI 75 and PGA 0/1 responder rates were 80.1% and 63.7% in the certolizumab 400 mg group, 74.5% and 54.6% in the certolizumab 200 mg group, and 7.5% and 2.8% in the placebo group (P