Safety Profile of Anti-TNF Agents in Polish Pediatric Patients with Crohn’s Disease

Back ground: In recent years, monoclonal antibodies against TNF-alpha, infliximab (IFX) and Adalimumab, have been gaining increasing popularity in Crohn’s disease (CD) management. Many clinical trials have shown that biologics are generally well-tolerated and safe. However, the follow-up time with regards to safety is too short and data on that issue are still limited. The aim of this study was to analyze the cumulative safety profile of biologic therapy with IFX and/or ADA, documented during up to 8-year follow-up of Polish children with moderately to severely active CD. Patients and Methods: We have performed a retrospective analysis of 110 children, mean age 13.0 ±9.3 years, diagnosed with CD and treated with IFX and/or ADA within the period of 8 years, between 2005 and 2013. Safety data for all treated patients, collected throughout the entire treatment period, were included in the safety analyses. Results: A total of 67 treatment related adverse events (TRAEs) were recorded, including 43 (64.17%) for IFX and 24 (35.83%) for ADA. The majority of TEAEs were mild-to-moderate in intensity. The most frequently reported TEAEs included anemia (n=17, 20.23% for IFX and n=9, 23.08% for ADA) and mild infections (n=9, 10.7% for IFX and n=5, 12.8% for ADA). No serious adverse events (sAEs) were documented. Conclusion: Biologic therapy with infliximab and/or Adalimumab is generally well-tolerated and safe, and does carry the risk of sAEs.