Adalimumab: in Crohn's disease

Abstract

Adalimumab is a subcutaneously administered, recombinant, human IgG1 monoclonal antibody specific for human tumor necrosis factor (TNF). The clinical efficacy and safety of adalimumab in patients with moderate to severe Crohn's disease has been demonstrated in four pivotal, randomized, double-blind trials (CLASSIC-I, GAIN, CHARM, and CLASSIC-II) that included a total of >1400 patients. In the CLASSIC-I trial, adalimumab was significantly more effective than placebo for induction of remission in patients who had not previously received anti-TNF therapy. Adalimumab was also more effective than placebo for induction of remission in the GAIN study in patients who had either lost responsiveness or developed intolerance to infliximab. The CHARM trial showed that, among patients who responded to open-label adalimumab induction, maintenance therapy with adalimumab 40 mg weekly or every other week for up to 1 year was associated with significantly greater remission rates than placebo at weeks 26 and 56. In addition, significantly more adalimumab than placebo recipients achieved corticosteroid-free remission and had complete fistula closure. In CLASSIC-II, an extension of the CLASSIC-I trial, patients who were in remission after a short course of adalimumab and were randomized to receive up to 1 year's treatment with adalimumab 40 mg weekly or every other week were significantly more likely to remain in remission than those randomized to receive placebo. In general, the tolerability profile of adalimumab in patients with Crohn's disease was similar to that in patients with rheumatoid arthritis or other approved indications.