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Adalimumab: A Review of Its Use in the Treatment of Patients with Ulcerative Colitis

BioDrugs volume 27, pages 247–262 (2013)Cite this article

Abstract

Adalimumab is a fully human, recombinant, monoclonal IgG1 antibody specific for the cytokine tumor necrosis factor-α. It is approved for the treatment of patients with inflammatory diseases, including adults with moderately to severely active ulcerative colitis who are refractory to, or intolerant of, corticosteroids and/or immunomodulators. In two well-designed 8- and 52-week clinical trials in patients with moderately to severely active ulcerative colitis despite treatment with corticosteroids and/or immunomodulators, subcutaneous adalimumab (160 mg, week 0; 80 mg, week 2; 40 mg every other week starting at week 4) was more effective than placebo for inducing and maintaining clinical remission. A statistically significant effect size (albeit <10 %) over placebo for the remission per Mayo score (primary endpoint) was observed with adalimumab at 8 weeks in both trials and at 52 weeks in one trial. Compared with placebo, adalimumab was associated with reductions in hospitalizations and improvements in other secondary endpoints, including clinical response, mucosal healing, corticosteroid-sparing, and health-related quality of life measures. Additionally, an early response to adalimumab was shown to be predictive of long-term efficacy. Adalimumab was generally well tolerated, compared with placebo, during clinical trials in patients with ulcerative colitis; the adverse event profile was similar to that in patients with Crohn’s disease or other approved indications. Adalimumab provides a new treatment option for patients with moderately to severely active ulcerative colitis who are refractory to, or intolerant of, corticosteroids and/or immunomodulators.

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Disclosure

The preparation of this review was not supported by any external funding. During the peer review process, the manufacturer of the agent under review was offered an opportunity to comment on this article. Changes resulting from comments received were made by the author on the basis of scientific and editorial merit.

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  1. Adis, 41 Centorian Drive, Private Bag 65901, Mairangi Bay, North Shore, 0754, Auckland, New Zealand

    Celeste B. Burness & Gillian M. Keating

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  1. Celeste B. Burness
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Corresponding author

Correspondence to Celeste B. Burness.

Additional information

The manuscript was reviewed by: V. Annese, Unit of Gastroenterology SOD2, Azienda Ospedaliero Universitaria (AOU) Careggi, University Hospital, Florence, Italy; D.B. Sachar, Division of Gastroenterology, Mount Sinai School of Medicine, New York, New York, USA; B. Shen, Department of Gastroenterology and Hepatology, Cleveland Clinic Foundation, Cleveland, Ohio, USA.

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Burness, C.B., Keating, G.M. Adalimumab: A Review of Its Use in the Treatment of Patients with Ulcerative Colitis. BioDrugs 27, 247–262 (2013). https://doi.org/10.1007/s40259-013-0033-6

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  • DOI: https://doi.org/10.1007/s40259-013-0033-6

Keywords

  • Ulcerative Colitis
  • Adalimumab
  • Mucosal Healing
  • Active Ulcerative Colitis
  • Mayo Score