Safety of biologic therapy


  • Wojciech Blonski MD,

    1. Department of Gastroenterology and Hepatology, Wroclaw Medical University, Wroclaw, Poland
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  • Gary R. Lichtenstein MD

    Corresponding author
    1. Division of Gastroenterology, University of Pennsylvania Health System, Philadelphia, Pennsylvania
    • Professor of Medicine, Hospital of the University of Pennsylvania, University of Pennsylvania School of Medicine, 3rd Floor, Ravdin Building, 3400 Spruce Street, Philadelphia, PA 19104-4283
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Several biologic agents have been assessed in patients with inflammatory bowel disease (IBD; Crohn's disease [CD] and ulcerative colitis [UC]). Until recently, only infliximab (humanized monoclonal anti-TNF-α antibody) had been approved by the Food and Drug Administration (FDA) to induce and maintain remission in patients with active mild to moderate and/or fistulizing Crohn's disease who are refractory to conventional therapy. Two recent trials, ACT 1 and ACT2, observed high efficacy of infliximab in inducing and maintaining clinical remission, mucosal healing, and corticosteroid-sparing effects in patients with moderate to severe UC. This agent also was recently approved by the FDA for the treatment of ulcerative colitis to reduce signs and symptoms, to induce clinical remission and healing of the intestinal mucosa, and to eliminate the use of corticosteroids in patients with moderately to severely active UC who have had an inadequate response to conventional therapy. There have been many randomized, double-blind, controlled and open-label uncontrolled studies of large and small numbers of patients assessing the efficacy and safety of various biologic agents considered potentially useful in the treatment of IBD.

Among all the biologic agents, infliximab has the most robust data on safety. This is because it has been evaluated in many more trials than has any other biologic agent. In addition, postmarketing experience provides very valuable information about adverse events occurring during treatment with this agent.

(Inflamm Bowel Dis 2007)