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Adalimumab

In Crohn’s Disease

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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 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.

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Notes

  1. The use of trade names is for product identification purposes only and does not imply endorsement.

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Authors and Affiliations

  1. Wolters Kluwer Health / Adis, 41 Centorian Drive, Private Bag 65901, Mairangi Bay, Auckland, 1311, New Zealand

    Greg L. Plosker & Katherine A. Lyseng-Williamson

  2. Wolters Kluwer Health, Conshohocken, Pennsylvania, USA

    Greg L. Plosker & Katherine A. Lyseng-Williamson

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  1. Greg L. Plosker
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  2. Katherine A. Lyseng-Williamson
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Correspondence to Greg L. Plosker.

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Plosker, G.L., Lyseng-Williamson, K.A. Adalimumab. BioDrugs 21, 125–132 (2007). https://doi.org/10.2165/00063030-200721020-00007

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