The CIMPASI-1 and CIMPASI-2 trials were the first Phase 3 clinical trials conducted with certolizumab pegol (Cimzia) to treat moderate to severe chronic plaque psoriasis. These randomized, parallel-group multicenter studies were designed to evaluate the efficacy and safety of certolizumab pegol. Based on the positive results of these two studies, a third study, CIMPACT, was developed to compare the safety and efficacy of certolizumab pegol with placebo in moderate to severe chronic plaque psoriasis patients. The secondary endpoint compared the efficacy and safety of certolizumab pegol with etanercept.1
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CIMPACT had a multi-center, placebo-controlled and active-controlled design. Five hundred and fifty-nine patients with moderate to severe chronic plaque psoriasis were randomized into one of four dosing arms: Group A received 400 mg certolizumab pegol every two weeks (n=167); Group B received 400 mg certolizumab pegol at Weeks 0, 2 and 4 followed by 200 mg certolizumab pegol every two weeks (n=165); Group C received 50 mg etanercept twice weekly (n=170); and Group D received placebo every two weeks (n=57).
Certolizumab pegol demonstrated statistically significant improvements for the primary endpoint, with the percentage of patients achieving a 75% or greater disease improvement from baseline as measured by the Psoriasis Area and Severity Index (PASI75) compared with placebo at Week 12. At Week 12, the PASI75 response rate for Group A was 66.7%, the PASI75 response rate for Group B was 61.3% and the PASI75 response rate for Group D was 5.0%.
Additionally, certolizumab pegol achieved superiority at the 400 mg dose and non-inferiority at the 200 mg dose compared with etanercept. No new safety signals were identified.
Certolizumab pegol is not currently approved anywhere to treat plaque psoriasis. The manufacturer plans to submit marketing applications for this treatment in the third quarter of 2017.
Michele B. Kaufman, PharmD, BCGP, is a freelance medical writer based in New York City and a pharmacist at New York Presbyterian Lower Manhattan Hospital.
- Dermira. News release: Final Cimzia (certolizumab pegol) phase 3 trial meets primary efficacy endpoint in patients with moderate to severe chronic plaque psoriasis. 2017 Jan 18.