Certolizumab pegol for the treatment of chronic plaque psoriasis: Results through 48 weeks from 2 phase 3, multicenter, randomized, double-blinded, placebo-controlled studies (CIMPASI-1 and CIMPASI-2)

Abstract Background Certolizumab pegol, the only Fc-Free, PEGylated anti-tumor necrosis factor biologic, demonstrated clinically meaningful improvements and suggested a positive risk-benefit balance in phase 2 studies in adults with moderate-to-severe chronic plaque psoriasis. Objective Assess certolizumab efficacy and safety versus placebo in phase 3 studies. Methods Patients with moderate-to-severe chronic plaque psoriasis were randomized 2:2:1 to certolizumab 400 mg, 200 mg, or placebo every 2 weeks. At Week 16, certolizumab-treated patients achieving 50% reduction in psoriasis area and severity index continued treatment through Week 48. Coprimary endpoints were Week 16 responder rates, defined as 75% reduction in psoriasis area and severity index and physician's global assessment 0/1 (‘clear'/‘almost clear' and ≥2-point improvement). Safety was assessed by treatment-emergent adverse events. Results Week 16 endpoints were significantly greater for both doses of certolizumab versus placebo, and responses maintained through Week 48. For most measures, improvement was numerically greater for certolizumab 400 mg. No unexpected safety signals were identified. Limitations No active comparator. Conclusions Treatment with either certolizumab 400 mg or 200 mg every 2 weeks was associated with significant, clinically meaningful improvements in moderate-to-severe psoriasis. The 400 mg dose may provide additional clinical benefit. The safety profile was consistent with the therapeutic class.