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.