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Erschienen in:
01.03.2007 | Adis Drug Profile
Adalimumab
In Crohn’s Disease
Erschienen in: BioDrugs | Ausgabe 2/2007
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▴ 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 40mg 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 40mg 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.