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)

JOURNAL OF THE AMERICAN ACADEMY OF DERMATOLOGY

卷:79

Article

Gottlieb, Alice B.¹  Blauvelt, Andrew²  Thaci, Diamant³  Leonardi, Craig L.^4,5  Poulin, Yves⁶  Drew, Janice⁷  Peterson, Luke⁸  Arendt, Catherine⁹  Burge, Daniel⁷  Reich, Kristian^10,11 

[1] New York Med Coll, Metropolitan Hosp, New York, NY USA

[2] Oregon Med Res Ctr, Portland, OR USA

[3] Univ Hosp Schleswig Holstein Lubeck, Comprehens Ctr Inflammat Med, Lubeck, Germany

[4] Cent Dermatol, St Louis, MO USA

[5] St Louis Univ, Sch Med, St Louis, MO 63103 USA

[6] Ctr Rech Dermatol Quebec Metropolitain, Quebec City, PQ, Canada

[7] Dermira Inc, Menlo Pk, CA USA

[8] UCB Pharma, Raleigh, NC USA

[9] UCB Pharma, Brussels, Belgium

[10] Dermatologikum Hamburg, Hamburg, Germany

[11] SCIderm Res Inst, Hamburg, Germany

关键词: anti-TNF;    antietumor necrosis factor;    certolizumab pegol;    chronic plaque psoriasis;    CIMPASI-1;    CIMPASI-2;    phase 3 trial;   

DOI  :  10.1016/j.jaad.2018.04.012

来源: Elsevier

【 摘 要 】

Background: Certolizumab pegol, the only Fc-free, PEGylated antietumor necrosis factor biologic, demonstrated clinically meaningful improvements suggestive of 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, certolizumab 200 mg, or placebo every 2 weeks. At week 16, certolizumab-treated patients achieving a 50% reduction in Psoriasis Area and Severity Index continued treatment through week 48. Coprimary endpoints were week 16 responder rates, defined as a 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 the responses were maintained through week 48. For most measures, improvement was numerically greater for certolizumab 400 mg. No unexpected safety signals were identified. Limitation: There was no active comparator. Conclusion: Treatment with either certolizumab 400 mg or 200 mg every 2 weeks was associated with significant and clinically meaningful improvements in moderate-to-severe psoriasis. The 400-mg dose could provide additional clinical benefit. The safety profile was consistent with the therapeutic class.

【 授权许可】

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