Three‐year efficacy and safety of certolizumab pegol for the treatment of plaque psoriasis: results from the randomized phase 3 CIMPACT trial

Abstract

Abstract: Background: Certolizumab pegol (CZP) is an Fc‐free, PEGylated anti‐tumor necrosis factor biologic. Objectives: To report 3‐year outcomes from the CIMPACT (NCT02346240) phase 3, CZP in moderate to severe plaque psoriasis, randomized controlled trial. Methods: Adults were randomized 3:3:3:1 to CZP 200 mg every other week (Q2W), CZP 400 mg Q2W, etanercept biweekly or placebo. At Week 16, CZP‐ and etanercept‐treated PASI 75 responders were re‐randomized to CZP 200 mg Q2W, CZP 400 mg Q4W, CZP 400 mg Q2W or placebo for maintenance treatment; PASI 75 non‐responders entered an open‐label escape CZP 400 mg Q2W arm. Patients entering the open‐label extension (OLE; Weeks 48–144) from blinded treatment received CZP 200 mg Q2W. Results: Double‐blinded results have been reported previously. 261 patients received 200 mg Q2W upon OLE entry. PASI 75 response was maintained in patients continuing 200 mg Q2W treatment through Weeks 16–144 (Week 144: 96.2%). In patients dosed down at Week 48 (double‐blinded 400 mg to 200 mg Q2W), PASI 75 decreased (Week 48: 98.7%; Week 144: 85.9%). In patients who received placebo through Weeks 16–48, PASI 75 response decreased (Week 48: 60.4%), then increased following Week 48 switch to 200 mg Q2W (Week 144: 95.1%). 48 and 36 patients initially randomized to 200 and 400 mg Q2W, respectively, were Week 16 PASI 75 non‐responders and entered the escape arm; at Week 144, 71.8% and 78.2% achieved PASI 75. No new safety signals were identified. Conclusions: Response to CZP was durable over three years; no new safety signals were identified.