ABSTRACT
Ustekinumab (UST) is a human IgG1K monoclonal antibody that binds to the p40 receptor subunit bound by cytokines IL-12 and IL-23. It is indicated in both Crohn's disease and ulcerative colitis as a second-line agent. The safety and efficacy of UST in children and young adults has not been thoroughly studied. We report a case series of six pediatric patients and young adults who developed hypersensitivity reactions during intravenous infusion with UST. These reactions ranged from mild allergic reactions to anaphylaxis, with no detectable antibodies if tested. We hypothesize the reaction could be secondary to ethylenediaminetetraacetic acid, which is present solely in the intravenous preparation. Patients who experience hypersensitivity reactions during their UST infusion may safely receive subcutaneous preparations of UST, as demonstrated by some patients who received it based on physician discretion. Further investigation is required to establish the etiology of infusion reactions.
ABSTRACT
BACKGROUND: Infliximab (IFX) infusion may lead to development of anti-IFX antibodies, and subsequent infusion reactions (IRs). The safety of rapid IFX infusion administered over 60 minutes has been under-investigated in children with inflammatory bowel disease. In a multicenter study, the frequency and nature of rapid infusion-associated IRs were examined. METHODS: The medical records of all consecutive children with inflammatory bowel disease receiving rapid IFX infusions between January 2014 and December 2016 were reviewed. Poisson regression analysis was used to identify possible associated factors with IRs. RESULTS: A total of 4120 rapid infusions for 453 children (median age 16 yrs [interquartile range 13.8-17.8], 289 males, 374 with Crohn's disease) were included. One hundred thirty-five participants (29.8%) received rapid IFX infusion for induction and maintenance while the rest received rapid IFX infusion after a median of 5 (interquartile range 4-9) standard infusions. The median dose of IFX using rapid protocol was 8 mg/kg/infusion (interquartile range 6-10). Two hundred sixty-seven (59%) patients received 1 or more premedications and 161 (35.5%) participants received concomitant immunosuppression. Twenty-one participants (4.6%) had IRs with rapid infusions and 2 participants discontinued IFX because of IRs (0.4%). Antihistamine premedications were associated with less frequent IR (adjusted relative risk = 0.30; 95% confidence interval, 0.14-0.64; P = 0.002). CONCLUSIONS: In children with inflammatory bowel disease, rapid IFX infusion administered over 60 minutes is safe and well-tolerated. Antihistamine premedications may reduce frequency of IRs (see Video Abstract, Supplemental Digital Content 1, http://links.lww.com/IBD/B632).