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P226. Prevention of infusion reactions to infliximab in pediatric patients

A. Hämäläinen, P. Lahdenne, A. Wikström, K. Aalto, K. Kolho

Hospital for Children and Adolescents, Helsinki, Finland

Aim: The use of TNF-α antagonist infliximab is emerging in the treatment of patients with moderate to severe juvenile idiopathic arthritis (JIA) and inflammatory bowel disease (IBD). Infusion reactions, a frequent adverse event of infliximab infusions, have been suggested to resemble niacin-like reactions mediated by prostaglandin D2. Since acetaminophen is a potent inhibitor of cyclooxygenase enzymes producing prostaglandin D2 only centrally, we determined the possibility of preventing infusion reactions through peripheral cyclooxygenase inhibition with ASA.

Materials and Methods: A protocol for premedication with ASA prior to infliximab infusions was established prospectively for 67 weeks. A weight-adjusted dose of ASA was administered orally 30 minutes prior to infliximab infusion. Treatment with infliximab was carried out according to standard protocols for 88 young patients with a diagnosis of JIA (n = 33, other n = 4) or IBD (Crohn's disease n = 32, ulcerative colitis n = 16, indeterminate colitis n = 3). Adverse events seen during infusions were recorded.

Results: 547 infliximab infusions were given during the study period: 484 with ASA premedication, 50 without use of ASA, 4 with acetaminophen and cetirizine, and 11 with ASA and intravenous methylprednisolone due to an earlier infusion reaction. In these respective groups, infusion reactions were observed in 1 (0.2%), 1 (2.0%), 0 and 4 (36.4% cases, which could not be prevented by concomitant use of immunosuppressive agents (azathioprine and methotrexate). The adolescent who reacted adversely to infliximab despite routine use of ASA had also experienced a reaction five years earlier and was diagnosed with asthma in addition to JIA, possibly contributing to the reaction pathogenesis. An allergic reaction to ASA was seen in one patient. ASA was significantly more efficient than other premedications used in this study population (p = 0.0001) and in our previous study concentrating on acetaminophen and cetirizine (p = 0.0017), Figures 1A and 1B.

Figure 1A. Infusion reactions to infliximab in relation to premedication in 88 pediatric patients and 547 infusions. Comparing ASA with all other premedication types combined, p = 0.0001 using Fisher's exact test. ASA = acetylsalicylic acid.

Figure 1B. Comparison of infusion reactions to infliximab between data on our current premedication with ASA and data obtained on acetaminophen and cetirizine during our former study, which included 65 pediatric patients and 383 infusions. p = 0.0017 using Fisher's exact test. ASA = acetylsalicylic acid.

Conclusion: Few infusion reactions associated with infliximab were observed when using routine ASA premedication. Our results also suggest that glucocorticoids may have poor efficacy in this indication. Despite minor limitations related to asthma and allergy to ASA, peroral ASA seems very promising in preventing infusion reactions in infliximab-treated pediatric patients.