Date: 2016-12-08
Type of information: Results
phase: 3
Announcement: results
Company: UCB (Belgium)
Product: Cimzia® (certolizumab pegol)
Action
mechanism: monoclonal antibody. Certolizumab is a recombinant Fab' antibody fragment against tumor necrosis factor alpha (TNF alpha) which is conjugated to polyethylene glycol pegol.
Disease: psoriasis
Therapeutic area: Autoimmune diseases - Dermatological diseases
Country: Canada, Czech Republic, Germany, Hungary, USA
Trial
details: The purpose of this study is to investigate the efficacy and safety of two dose levels of certolizumab pegol in adults with moderate to severe chronic plaque psoriasis when administered every 2 weeks. (NCT02326298)
Latest
news: * On December 8, 2016, UCB and Dermira announced topline results from CIMPASI-1, a Phase 3, 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-1 trial, Cimzia® demonstrated statistically significant improvements for both co-primary endpoints compared to placebo at both treatment doses. This is the second of three Phase 3 clinical trials evaluating Cimzia® in this patient population. UCB and Dermira announced topline results from CIMPASI-2 in October 2016. CIMPASI-1 had an identical trial design to CIMPASI-2. The co-primary endpoints evaluated in both trials were the percentage of patients who achieved a 75% or greater disease improvement from baseline as measured by the Psoriasis Area and Severity Index (PASI 75) and the percentage of patients achieving at least a two-point improvement on a five-point Physician’s Global Assessment (PGA) scale to a final score representing clear or almost clear skin, each compared with placebo, at week 16.
In the CIMPASI-1 trial, consistent with the results of the CIMPASI-2 trial, Cimzia® demonstrated statistically significant improvements from baseline to week 16 relative to placebo for both co-primary endpoints at both treatment doses.
A total of 234 patients with moderate-to-severe chronic plaque psoriasis were randomized in the CIMPASI-1 trial to three dosing arms—400 mg every two weeks (n=88), 400 mg at weeks 0, 2, and 4 followed by 200 mg every two weeks (n=95), or placebo every two weeks (n=51). At week 16, the response rate for patients who achieved a PASI 75 was 75.8% for patients receiving the 400 mg dose every two weeks and 66.5% for patients receiving the 200 mg dose every two weeks, compared to 6.5% 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 57.9% for the 400 mg dose-treated patients and 47.0% for the 200 mg dose-treated patients, compared to 4.2% for the patients receiving placebo.
The adverse event profile appears consistent with the adverse event profiles observed with Cimzia® in currently approved indications. The data from this trial will be submitted for presentation at an upcoming medical congress and to a peer-reviewed medical journal for publication.
