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Adalimumab for Crohn Disease That Is Refractory to Infliximab

Adalimumab benefits infliximab-experienced patients, in addition to those who are infliximab naive.

Adalimumab is a commercially available, entirely humanized, anti-tumor-necrosis–factor monoclonal antibody that is effective in inducing and maintaining remission in patients who have Crohn disease and no previous exposure to infliximab (Journal Watch Gastroenterology Mar 28 2006). However, whether adalimumab also is effective in patients who already have received infliximab is unknown.

In an industry-sponsored international study, 325 patients (age range, 18–75), who were either intolerant of infliximab or had responded to infliximab previously and then lost their response, were randomized to receive adalimumab (160 mg and 80 mg at week 0 and 2, respectively) or placebo. Participants were followed for 4 weeks.

Remission occurred in 21% of the adalimumab group and in 7% of the placebo group (P<0.001). Decreases of 70 points or more in the Crohn’s Disease Activity Index occurred in 52% of the adalimumab group and 34% of the placebo group.

Comment: The overall response rates indicate that infliximab-experienced patients are difficult to treat. Nevertheless, the study provides clear evidence that adalimumab benefits patients who are intolerant of or who have lost their response to infliximab.

— Douglas K. Rex, MD

Published in Journal Watch Gastroenterology August 17, 2007

Citation(s):

Sandborn WJ et al. Adalimumab induction therapy for Crohn disease previously treated with infliximab: A randomized trial. Ann Intern Med 2007 Jun 19; 146:829-38.

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