Certolizumab Pegol for the Treatment of Chronic Plaque Psoriasis: Results Through 48 Weeks of a Phase 3, Multicenter, Randomized, Double-Blinded, Etanercept- and Placebo-Controlled Study (CIMPACT)

Publication date: Available online 14 April 2018
Source:Journal of the American Academy of Dermatology
Author(s): Mark Lebwohl, Andrew Blauvelt, Carle Paul, Howard Sofen, Jolanta Węgłowska, Vincent Piguet, Daniel Burge, Robert Rolleri, Janice Drew, Luke Peterson, Matthias Augustin
BackgroundPhase 2 psoriasis studies with the Fc-free, PEGylated, anti-tumor necrosis factor biologic certolizumab pegol demonstrated meaningful clinical activity.ObjectiveAssess safety and efficacy of certolizumab in adults with moderate-to-severe chronic plaque psoriasis.MethodsPatients were randomized 3:3:1:3 to certolizumab 400 mg, 200 mg, or placebo every 2 weeks for 16 weeks or etanercept 50 mg twice-weekly for 12 weeks. Certolizumab-treated patients achieving ≥75% reduction in psoriasis area and severity index at Week 16 were re-randomized to certolizumab or placebo for 32 weeks. The primary endpoint was responder rate (≥75% reduction in psoriasis area and severity index) versus placebo (primary analysis) and etanercept (secondary analysis) at Week 12; secondary endpoints included responder rates on various measures versus placebo at Weeks 12, 16, and 48. Safety was assessed by treatment-emergent adverse events.ResultsAll endpoints were significantly greater for certolizumab versus placebo with the greatest response seen with 400 mg. Certolizumab 400 mg was superior to and 200 mg was noninferior to etanercept. Adverse events were consistent with the anti-tumor necrosis factor class.LimitationsSingle-blind etanercept.ConclusionBoth certolizumab regimens improved psoriasis symptoms with greater response at the higher dose. No new safety signals were observed.

Teaser

Certolizumab pegol is an Fc-free, PEGylated anti-tumor necrosis factor biologic.; In this phase 3 study, both certolizumab doses improved psoriasis symptoms at Week 12 that was maintained, following re-randomization, through Week 48 with a safety profile consistent with its class.; The higher dose of certolizumab may provide superior efficacy.