Certolizumab reinduction helpful in Crohn's disease

Last Updated: 2010-04-22 14:47:09 -0400 (Reuters Health)

By David Douglas

NEW YORK (Reuters Health) - Patients with Crohn's disease who respond to induction with certolizumab pegol (Cimzia) and then relapse will often respond to it again, new research shows.

In the current study, when Crohn's patients on certolizumab pegol maintenance therapy had a relapse, "we evaluated a novel strategy of temporary dose intensification (which we called reinduction) and then going back to the low maintenance dosing regimen which the patient was taking at the time of the relapse," lead author Dr. William J. Sandborn told Reuters Health by e-mail.

Dr. Sandborn, of the Mayo Clinic in Rochester, Minnesota, and colleagues studied participants in the PRECiSE 2 trial. In that trial, patients with moderate to severe Crohn's disease received induction therapy with certolizumab pegol. At six weeks, the researchers randomly assigned all responders to either continue on certolizumab, at a maintenance dose of 400 mg every four weeks, or switch to placebo (drug interruption). The responders who relapsed at some point between weeks 6 and 26 formed the cohort for the reinduction study (PRECiSE 4).

As the authors reported online April 5th in Clinical Gastroenterology and Hepatology, continuous-therapy patients received a single extra 400-mg dose of certolizumab pegol for reinduction. In the drug-interruption group, reinduction consisted of 400-mg doses of certolizumab pegol at weeks 0, 2, and 4 followed by maintenance with certolizumab pegol 400 mg every four weeks.

"Somewhat surprisingly, we found that approximately 60% of patients responded to this strategy in the short term, and about 30% of patients in the longer term," Dr. Sandborn said.

Specifically, at four weeks after the start of reinduction, 63% of the continuous-therapy group and 65% of the drug-interruption group had responded. At week 52, 55% and 59%, respectively, of the responders in these two groups had maintained their response.

"Because of the favorable pharmacoeconomics of this strategy, it is another therapeutic option for clinicians to consider in this patient population," Dr. Sandborn concluded.

The study was funded by UCB Pharma, Brussels.

Clin Gastroenterol Hepatol 2010.