Certolizumab Pegol for the treatment of chronic plaque psoriasis: results through 48 weeks of a phase 3, multicenter, andomized, double-blinded, etanercept- and placebo-controlled study (CIMPACT)

Lebwohl, Mark, Blauvelt, Andrew, Paul, Carle, Sofen, Howard, Węgłowska, Jolanta, Piguet, Vincent, Burge, Daniel, Rolleri, Robert, Drew, Janice, Peterson, Luke and Augustin, Matthias 2018. Certolizumab Pegol for the treatment of chronic plaque psoriasis: results through 48 weeks of a phase 3, multicenter, andomized, double-blinded, etanercept- and placebo-controlled study (CIMPACT). Journal of The American Academy of Dermatology 79 (2) , 266-276.e5. 10.1016/j.jaad.2018.04.013

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Abstract

Background Phase 2 psoriasis studies with the Fc-free, PEGylated, anti-tumor necrosis factor biologic certolizumab pegol demonstrated meaningful clinical activity. Objective Assess safety and efficacy of certolizumab in adults with moderate-to-severe chronic plaque psoriasis. Methods Patients 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. Results All 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. Limitations Single-blind etanercept. Conclusion Both certolizumab regimens improved psoriasis symptoms with greater response at the higher dose. No new safety signals were observed.

Item Type:	Article
Date Type:	Publication
Status:	Published
Schools:	Schools > Medicine
Additional Information:	Creative Commons Attribution – NonCommercial – NoDerivs (CC BY-NC-ND 4.0)
Publisher:	Elsevier
ISSN:	0190-9622
Date of First Compliant Deposit:	4 May 2018
Date of Acceptance:	5 April 2018
Last Modified:	09 Jun 2020 14:46
URI:	https://orca.cardiff.ac.uk/id/eprint/111207

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