Date: 2017-01-19
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: Bulgaria, Czech Republic, France, Germany, Hungary, Netherlands, Poland, UK, USA
Trial
details: The purpose of this study is to investigate the efficacy and safety of two dose levels of certolizumab pegol compared to active comparator and placebo in adults with moderate to severe chronic plaque psoriasis. (NCT02346240)
Latest
news: * On January 19, 2017, UCB and Dermira announced key results from CIMPACT, a Phase 3, multi-center, placebo-controlled and active-controlled clinical trial evaluating the efficacy and safety of Cimzia® (certolizumab pegol) in adult patients with moderate-to-severe chronic plaque psoriasis. In the CIMPACT trial, Cimzia® demonstrated statistically significant improvements for the primary endpoint. CIMPACT is the third and final Phase 3 clinical trial evaluating Cimzia® in this patient population.
The primary endpoint in CIMPACT assessed the percentage of patients on Cimzia® who achieved a 75% or greater disease improvement from baseline as measured by the Psoriasis Area and Severity Index (PASI 75), compared with placebo, at week 12. Several secondary endpoints were assessed, including comparisons of the efficacy of Cimzia® to Enbrel® based on PASI 75 response rates at week 12 and comparisons of the response rates of Cimzia®-treated patients to placebo-treated patients at week 16 using (1) PASI 75 and (2) 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. In both the CIMPASI-1 and CIMPASI-2 trials, PASI 75 and PGA were co-primary endpoints assessed at week 16. In all three Cimzia® Phase 3 clinical trials, Cimzia® demonstrated statistically significant improvements for all primary or co-primary endpoints compared to placebo at both treatment doses.
CIMPACT Results: A total of 559 patients with moderate-to-severe chronic plaque psoriasis were randomized in the CIMPACT trial to one of four dosing arms—Cimzia® at 400 mg every two weeks (n=167), Cimzia® at 400 mg at weeks 0, 2, and 4 followed by 200 mg every two weeks (n=165), Enbrel at 50 mg twice weekly (n=170), or placebo every two weeks (n=57).
Cimzia® demonstrated statistically significant improvements in the primary endpoint. At week 12, the response rate for patients who achieved a PASI 75 was 66.7% for patients receiving the Cimzia® 400 mg dose every two weeks and 61.3.% for patients receiving the Cimzia® 200 mg dose every two weeks, compared to 5.0% for patients receiving placebo.
The CIMPACT trial also assessed a number of secondary endpoints, including:
At week 16, the response rate for patients who achieved a PASI 75 was 74.7% for patients receiving the 400 mg dose every two weeks and 68.2% for patients receiving the 200 mg dose every two weeks, compared to 3.8% 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 58.4% for the 400 mg dose-treated patients and 48.3% for the 200 mg dose-treated patients, compared to 3.4% for the patients receiving placebo.
At week 16, both Cimzia® dosing arms were statistically significant compared to placebo for the PASI 75 and PGA secondary endpoints.
At week 12, Cimzia® achieved superiority at the 400 mg dose and non-inferiority at the 200 mg dose compared to Enbrel.
CIMPASI-1 Results: A total of 234 patients with moderate-to-severe chronic plaque psoriasis were randomized in the CIMPASI-1 trial to one of 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.
CIMPASI-2 Results: A total of 227 patients with moderate-to-severe chronic plaque psoriasis were randomized to one of three dosing arms—400 mg every two weeks (n=87), 400 mg at weeks 0, 2, and 4 followed by 200 mg every two weeks (n=91), or placebo every two weeks (n=49).
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.
The adverse event profile across all three trials appears consistent with the adverse event profiles observed with Cimzia® in currently approved indications.
The data from these trials will be submitted for presentation at an upcoming medical congress and to a peer-reviewed medical journal for publication.Based on the results of the CIMPACT trial, and those from the previously reported CIMPASI-1 and CIMPASI-2 trials, UCB intends to submit marketing applications to regulatory authorities in the third quarter of 2017.
