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Certolizumab pegol improved endoscopic lesions in patients with Crohn’s disease
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Endoscopic lesions improved in patients with active Crohn’s disease following certolizumab pegol treatment, according to the results of phase 3B multicenter open-label clinical trials.
Researchers enrolled 89 adult patients with active endoscopic disease (ulceration in at least two intestinal segments with a Crohn’s Disease Endoscopic Index of Severity [CDEIS] score of at least 8 points).
Patients were administered 400 mg certolizumab pegol (Cimzia, UCB) subcutaneously at weeks 0, 2 and 4 and every 4 weeks for 1 year. Endoscopic evaluations at week 10 measured mean change in CDEIS.
The mean CDEIS score was 14.5±5.3 at baseline for 89 patients in the intention-to-treat population. The mean CDEIS score decrease at week 10 was 5.7 (95% CI, 4.6-6.8).
Other response rates at 10 weeks and 54 weeks, respectively, were:
Endoscopic response: 54%; 49%
Endoscopic remission: 37%; 27%
Complete endoscopic remission: 10%; 14%
“Despite the endoscopic improvement observed, the rate of complete mucosal healing was relatively low,” the study researchers wrote. “This may have been a consequence, at least in part, of the severity of intestinal lesions at baseline — more than 90% of patients having deep ulcerations — and the inclusion criterion for ulcerations in at least two intestinal segments.”
Disclosure: See the study for a full list of relevant disclosures.
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