Cochrane review confirms efficacy of certolizumab in Crohn's

Last Updated: 2019-09-30

By Reuters Staff

NEW YORK (Reuters Health) - Certolizumab pegol (CZP) is more effective than placebo for inducing remission in Crohn's disease (CD), based on moderate evidence, according to a new Cochrane review.

"Future studies are needed to evaluate the long-term efficacy and safety of CZP in CD patients," Dr. Hajime Yamazaki of Kyoto University in Japan and colleagues conclude in their report, online August 29 in the Cochrane Database of Systematic Reviews.

CZP is a tumor necrosis factor-alpha inhibitor approved for treating CD in the U.S. and Switzerland. Meta-analyses of CZP for CD have had mixed results, the authors note, "which may be due to differences in methodology and in the selected time points for the assessment of clinical remission."

The new meta-analysis included four studies and 1,485 patients. All studies were randomized, double-blind controlled trials funded by UCB Inc., the maker of CZP.

In doses of 100 mg to 400 mg every two to four weeks, CZP was more effective than placebo for inducing a clinical response and inducing remission.

At eight weeks, 26.9% of the CZP group and 19.8% of the placebo group patients were in remission, a significant difference (relative risk, 1.36); 40.2% of patients on CZP and 30.9% of the placebo group had a clinical response (RR, 1.29), also a significant result.

Serious adverse events, including worsening CD, infections, and malignancy, were not significantly more common in CZP patients (8.7%) than in placebo patients (6.2%; RR, 1.35).

"These results suggest a clear benefit of CZP for active CD patients. Higher CRP improvement in patients with CZP than those with placebo is in accordance with this evidence," Dr. Yamazaki and colleagues write.

"With respect to safety, there may be no clear difference in adverse events and withdrawal due to adverse events," they add. "Moreover, it is uncertain whether the risk of serious adverse events differs between CZP and placebo as the 95% CI includes the possibility of a small decrease or doubling of events."

SOURCE: https://bit.ly/2naQxLA

Cochrane Database Syst Rev 2019.