Clinical–alimentary tractHuman Anti–Tumor Necrosis Factor Monoclonal Antibody (Adalimumab) in Crohn’s Disease: the CLASSIC-I Trial
Section snippets
Patients
This multicenter, randomized, double-blind, placebo-controlled trial was conducted at 55 centers between July 24, 2002, and December 18, 2003. The protocol was approved by the institutional review board or ethics committee at each center. All patients gave written informed consent.
Eligible patients included men and women (18–75 years of age) with Crohn’s disease for at least 4 months who had moderate to severe disease as defined by a Crohn’s Disease Activity Index (CDAI)24 score of 220–450
Characteristics of the Patients
A total of 299 patients were available for randomization at week 0 (Figure 1). The 299 patients were randomly assigned to receive placebo induction (74 patients) or adalimumab induction with 40 mg/20 mg (74 patients), 80 mg/40 mg (75 patients), or 160 mg/80 mg (76 patients). The baseline characteristics of the patients who received placebo were similar to those who received adalimumab (Table 1). Overall, premature withdrawal from the study occurred in 6 patients (8%) in the placebo group versus
Discussion
We found that induction therapy with adalimumab, administered subcutaneously as a loading dose at week 0 followed by a second dose at week 2, is superior to placebo for inducing remission and response in infliximab-naive patients with moderate to severe disease activity despite the use of conventional therapy. Patients who received the highest dose (160 mg/80 mg) of adalimumab were 3 times more likely to achieve remission and approximately twice as likely to achieve a 100-point response and
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Supported by a research grant from Abbott Laboratories (Abbott Park, IL).
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S.B.H., W.J.S., P.R., R.N.F., R.P., and D.W. have served as consultants for Abbott Laboratories. S.B.H., W.J.S., P.R., R.N.F., and R.P. have participated in continuing medical education events supported by unrestricted educational grants from Abbott Laboratories.