William J. Sandborn, MD; Paul Rutgeerts, MD, PhD; Robert Enns, MD; Stephen B. Hanauer, MD; Jean-Frédéric Colombel, MD; Remo Panaccione, MD; Geert D'Haens, MD; Ju Li, PhD; Marie R. Rosenfeld, BA; Jeffrey D. Kent, MD; Paul F. Pollack, MD
Can adalimumab, an anti–tumor necrosis factor (anti-TNF) agent, induce remission in patients with Crohn disease who do not respond to or cannot tolerate another anti-TNF agent?
This double-blind, placebo-controlled trial included 325 adults with Crohn disease who had symptoms despite treatment with infliximab or who could not tolerate infliximab because of adverse events. At 4 weeks, more patients randomly assigned to the adalimumab group achieved remission than did those in the placebo group (21% vs. 7%).
The trial did not directly compare efficacy of different anti-TNF agents and did not assess maintenance of response or the long-term immunogenicity of adalimumab.
*Patients with missing Crohn's Disease Activity Index scores were assumed to have had treatment failure.
Remission was defined as a decrease in the CDAI score to <150.
Differences are reported in percentage points, and error bars represent 95% CIs. Interaction P values were 0.88 for concomitant immunosuppressive therapy (azathioprine, 6-mercaptopurine, and methotrexate), 0.01 for concomitant corticosteroid therapy, 0.52 for previous loss of response to infliximab, 0.28 for previous intolerance of infliximab, 0.17 for previous loss of response to and intolerance of infliximab, 0.36 for presence of antibodies to infliximab at screening, and 0.67 for C-reactive protein (CRP) concentration ≥10 mg/L at week 0. *Missing data for 1 patient in the placebo group. †Missing data for 7 patients in the placebo group and 6 patients in the adalimumab group.
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Sandborn WJ, Rutgeerts P, Enns R, Hanauer SB, Colombel J, Panaccione R, et al. Adalimumab Induction Therapy for Crohn Disease Previously Treated with Infliximab: A Randomized Trial. Ann Intern Med. 2007;146:829-838. doi: 10.7326/0003-4819-146-12-200706190-00159
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Published: Ann Intern Med. 2007;146(12):829-838.
Gastroenterology/Hepatology, Inflammatory Bowel Disease, Prevention/Screening.
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