Safety of infliximab for the treatment of inflammatory bowel disease: current understanding of the potential for serious adverse events

Abstract

Introduction: Infliximab, a chimeric monoclonal antibody directed towards TNF-α, has revolutionized the treatment of inflammatory bowel disease (IBD). Since this therapy suppresses the immune system by neutralizing the immunological activity of TNF, concerns exist regarding the potential for infection, malignancy and immune disorders.

Areas covered: Comprehensive data from randomized controlled trials, meta-analyses and cohort studies have defined the risk of infection and malignancy with infliximab. Additional data regarding associations with immune disorders, such as drug-induced lupus, demyelinating syndromes and psoriaform skin disease have emerged, primarily from case reports. We report evidence from the most robust data sources that have examined these adverse events.

Expert opinion: A modest increase in the incidence of serious infection with infliximab and TNF-antagonists has been observed in methodologically rigorous studies. Combination therapy with an immunosuppressant does not confer a higher risk of serious infection than infliximab monotherapy. TNF-antagonist therapy alone with an immunosuppressant is not associated with higher rates of malignancy. Additional data are required to define causality, the magnitude and determinants of risk for other immune-related complications. Available data suggest the therapeutic index of infliximab is favorable for treatment of moderate-to-severe IBD.

Keywords:

• adverse events
• Crohn’s disease
• inflammatory bowel disease
• infliximab
• monoclonal antibodies
• safety
• treatment
• ulcerative colitis

Declaration of interest

R Khanna has received an honorarium from Jansen, AbbVie and Takeda. BG Feagan has received grant/research support from Abbott, Centocor and Milllennium; has served as a consultant for Abbott (AbbVie), Centocor, JnJ/Janssen, Merck, Millennium and Takeda; has served on speaker’s bureaus for Abbott, J&J/Janssen, UCB Pharma; and as a scientific advisory board member for Abbott, Centocor Inc., Merck, Takeda and UCB Pharma. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending or royalties.