What is the role of monoclonal antibodies in the treatment of refractory inflammatory bowel disease (IBD)?

Updated: Apr 10, 2020
  • Author: William A Rowe, MD; Chief Editor: BS Anand, MD  more...
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An alternative agent is infliximab, a monoclonal antibody against TNF-alpha. The FDA approved infliximab for the treatment of Crohn disease in July 2005 and for the treatment of ulcerative colitis in August 2005. To be effective for maintaining remission, this medication is generally administered in 3 doses of 5 mg/kg over 6 weeks (at weeks 0, 2, and 6), with maintenance doses every 8 weeks.

A randomized, controlled trial demonstrated that adalimumab can induce remission in patients with Crohn disease that is refractory to treatment with infliximab. [107] This therapy led to mucosal healing and a reduction in hospitalization and surgical intervention. The rate of serious infection was 2%-4%, which was no greater than the rate in patients receiving placebo. [107]

Note that in September 2011, the US Food and Drug Administration (FDA) issued a notification regarding updates to the Black Box Warning for the entire class of tumor necrosis factor (TNF)-alpha blockers. [108] The advisory included the risk of Legionella and Listeria infections, as well as consistency of the information in the Boxed Warning and the Warnings and Precautions sections regarding the risk of serious infections and the associated disease-causing organisms. [108]

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