ABSTRACT
Introduction: Tumor necrosis factor-α (TNF-α)-blocking agents are drugs approved for the treatment of inflammatory bowel diseases (IBDs). Infliximab and adalimumab are approved for the treatment of IBD in the pediatric setting with the improvement of therapeutic management. Biological agents, also in the pediatric population, can be administered either alone or in combination with immunomodulators. Their use has raised safety concerns regarding the risk of infections and malignancies.
Areas covered: A broad review of the safety concerns for the use of anti-TNF-α drugs in children with IBD was performed, and information regarding the risk of infections and malignancies were updated, also in comparison with the safety of traditional drugs such as steroids and/or immunosuppressants.
Expert commentary: Anti-TNF-α drugs have shown favorable safety profiles, and adalimumab treatment is associated with lower immunogenicity compared with infliximab. Heightened awareness and vigilant surveillance leading to prompt diagnosis and treatment are important for optimal management.
Article highlights
Opportunistic infections and malignancies are possible complications in pediatric IBD
Potential risks can be related to the disease or the use of steroids, immunosuppressants and biological therapies
Anti-TNF-α drugs seem to have favorable safety profiles, but no long-term surveillance data are available
The risk of infections and malignancies seems to be higher with a combination of anti-TNF-α and immunomodulators compared with anti-TNF-α alone
Immunocompetence and assessment of the immune and serological status should be evaluated before the start of anti-TNF-α therapy
Declaration of interest
The authors have no 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.
Reviewer disclosures
A reviewer on this manuscript has declared that they have acted as a consultant for and served on advisory boards of Janssen, Abbvie, and Merck; have received speaker’s fees from Janssen and Abbvie and received investigator-initiated research support from Abbvie. Peer reviewers on this manuscript have no other relevant financial relationships or otherwise to disclose.