No Late Surprises in Longest-Yet Trial of TNF Inhibitor

May 9, 2014

Used for up to 7 years in a long-term extension trial of Crohn's disease, the tumor necrosis factor inhibitor certolizumab pegol continued effective, and showed no unexpected adverse effects.

For patients with Crohn's disease who continue to take it for as long as 7 years, no previously unexpected adverse events associated with certolizumab pegol (Cimzia) have emerged, in the longest-running trial to date of a tumor-necrosis factor (TNF) inhibitor.

These results from an open-label  extension of the PRECISE trials were announced this week at Digestive Diseases Week in Chicago. The extension trial enrolled 595 patients with moderate to severe Crohn's disease who had completed a 26-week trial taking the 400 mg of the drug every 4 weeks, and continued for up to 7 years.

Only 117 patients completed the entire 7 years with the regimen. Of those who discontinued the drug, 36% did so because of adverse events. These were all consistent with those found in earlier trials, most commonly upper respiratory infections, according to Marshall Spearman MD, medical director of Cimzia's manufacturer, UCB Inc.

Remission rates remained high among those able to continue the medication (see chart below). The researchers also reported that, as has been found in other studies, remission rates were higher among patients who had not previously taken another TNF inhibitor (in this analysis, infliximab). The search for other factors that affect remission rates is continuing.

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The investigators point out that uncontrolled studies of this type are vulnerable to patient selection issues (patients in whom the treatment succeeds are most likely not to drop out). However, Spearman said that the lack of late events in the 7-year group is encouraging.

These results may be of interest to patients with comorbid Crohn's and rheumatic disease. For instance, Spearman said, spondyloarthropathies affect between one-fifth and one-fourth of Crohn's patients, and vice versa.

Certolizumab pegol is approved for the treatment of rheumatoid arthritis, psoriatic arthritis, and anklyosing spondylitis, as well as Crohn's disease.