Phase III data of Cimzia (certolizumab pegol) in chronic plaque psoriasis shows improvement in co-primary endpoints- UCB and Dermira

UCB and Dermira announced topline results from CIMPASI-2, a Phase III, multi-center, placebo-controlled clinical trial evaluating the efficacy and safety of Cimzia (certolizumab pegol) in adult patients with moderate-to-severe chronic plaque psoriasis. In the CIMPASI-2 trial, Cimzia demonstrated statistically significant improvements for both co-primary endpoints compared to placebo at both treatment doses. The CIMPASI-2 trial results are from the first of three Phase III clinical trials to be reported evaluating Cimzia in this patient population.

At week 16, the response rate for patients who achieved a PASI 75 was 82.6% for patients receiving the 400 mg dose every two weeks and 81.4% for patients receiving the 200 mg dose every two weeks, compared to 11.6% for patients receiving placebo. The response rate for patients achieving at least a two-point improvement to a final score of clear or almost clear skin on the PGA scale at week 16 was 71.6% for the 400 mg dose-treated patients and 66.8% for the 200 mg dose-treated patients, compared to 2.0% for the patients receiving placebo. Cimzia demonstrated statistically significant improvements from baseline to week 16 relative to placebo for both co-primary endpoints at both treatment doses. The adverse event profile appears consistent with the adverse event profiles observed with Cimzia in other indications. The data from this study will be submitted for presentation at an upcoming medical congress and to a peer-reviewed medical journal for publication.