Pivotal trials for adalimumab (ADA) demonstrated effectiveness versus placebo for induction and maintenance of remission in moderate to severely active Crohn's disease (CD). Although the approved maintenance regimen in the U.S. is 40 mg subcutaneously every 14 days, some patients require dose-escalation ([DE] either an increase in the delivered dose or decrease in the interval of treatment). Our objective was to determine which patient-, disease-, and therapy-related factors were associated with DE in CD patients treated with ADA.
This retrospective medical record review of patients included all patients treated with ADA for CD at the University of Chicago Inflammatory Bowel Disease Center between 2003 and 2008. Patient-related factors, disease-related factors, and therapy-related factors were analyzed. Survival and logistic regression analyses were performed.
In all, 75 patients treated with ADA between December 2003 and June 2008 were identified. Thirty-one subjects (41%) required DE (32% male, median age 37.6, median disease duration 22.7 years) after a median 20 weeks of therapy (range 2–75). Patient-, clinical-, and therapy-related factors were similar between DE and non-DE. Need for DE was predicted by a family history of inflammatory bowel disease (IBD) (P = 0.0187). Time to DE was predicted by male gender, isolated colonic disease, and smoking history (all P < 0.05); however, only male gender was an independent predictor of time to DE.
In all, 41% of CD patients required ADA DE, with shorter time to DE in smokers, men, and patients with isolated colonic disease. Patients, caregivers, and insurers should anticipate DE when utilizing ADA in CD. (Inflamm Bowel Dis 2011;)
1 Inflammatory Bowel Disease Center, University of Chicago, Chicago, Illinois
* Associate Professor of Medicine, Co-director, Inflammatory Bowel Disease Center, University of Chicago Medical Center, 5841 S. Maryland Ave., MC 4076, Chicago, IL 60637
Received 10 January 2011; Accepted 15 February 2011
Published online 31 March 2011 in Wiley Online Library (wileyonlinelibrary.com).
Supported in part by the American Gastroenterological Association Foundation Student Research Fellowship Award and the Digestive Disease Research Core Center of the University of Chicago (DK42086).