Premedication with intravenous steroids does not influence the incidence of infusion reactions following infliximab infusions in pediatric inflammatory bowel disease patients—a case-control study

Abstract

Purpose Infusion reactions (IR) are commonly described side effects of infliximab (IFX) infusions, often leading to discontinuation of IFX. This study aimed to investigate the influence of steroid premedication (PM) on incidence of IR in pediatric inflammatory bowel disease (PIBD) patients receiving IFX. Methods A case-control study in two tertiary centers in Amsterdam, The Netherlands, including PIBD patients receiving IFX. PM with steroids was part of standard care in one center (PM+) but not in the other center (PM−). Acute IR were divided into mild/severe reactions and in grade 1/2/3/4 for detailed exploration. Differences between subgroups were assessed with the T or chi-square test. Multivariate logistic regression was used to assess associations between PM and IR incidence, correcting for comedication usage. Results We included 226 patients (91 PM+, 50% male, mean age at onset of IBD 12.7 years), receiving 3433 infusions. There was no difference between the PM+ and PM− subgroups in incidence of IR (14.3% vs. 17.0% of patients, p = 0.58) and in percentage of infusions followed by IR (1.4% in both subgroups). The OR of developing IR when using PM was 1.06 (95% CI 0.49-2.27, p = 0.89), and the OR of developing a grade 3 or 4 IR when using PM was 0.90 (95% CI 0.24-3.39, p = 0.88) when correcting for co-medication usage. Conclusion The incidence of IR was low, and premedication with steroids did not decrease the incidence of IR in this cohort of PIBD patients receiving IFX. Our results indicate that PM with steroids is not indicated in PIBD to prevent IR.

Premedication Does Not Influence the Incidence of Infliximab Infusion Reactions in Pediatric Patients with Inflammatory Bowel Disease—A Single Center Case–Control Study

“…Eleven IRs were anaphylactic shock, and all of them resolved after steroid/antihistamine or adrenaline administration. Our results are comparable to the observations of other authors [18,19].…”

Safety of Rapid Infliximab Infusions in Children

“…As both adult and pediatric studies were only cohort studies and not randomized trials, one could argue that the superiority of rapid infusions was the result of selection bias, as participants only received fast infusions after tolerating the first few regular infusions. This argument is not, however, supported by a recent study on IR in 226 children with IBD, which reported that the first infusion reaction on average happens at the sixth infusion (13).…”

Same Day Infusion of Iron Therapy Is Associated With No Increased Risk for Adverse Events Among Patients Receiving Biological Infusions for Inflammatory Bowel Disease

“…17,18 A prior retrospective study of patients with inflammatory arthritis demonstrated that the premedication with methylprednisolone is effective in reducing the rates of arthralgia-myalgia syndrome after an iron dextran infusion. 18 In addition, Barton et al found that 87% of 135 patients with iron-deficiency anemia unresponsive to oral supplementation had no reaction to iron dextran infusion when premedicated with diphenhydramine, cimetidine, and dexamethasone. 17 Whether premedication is helpful in the prevention of iron infusion-related reactions remains an ongoing area of study, and will likely require further prospective evaluations.…”

“…These findings likely indicate the more widespread use of corticosteroid premedications among at risk patients. Premedications with methylprednisolone and an H 2 blocker before IV iron infusions are typically reserved for those patients who suspected to be at an increased risk of an allergic or infusion reaction, including patients with asthma or more than 1 drug allergy 17,18. A prior retrospective study of patients with inflammatory arthritis demonstrated that the premedication with methylprednisolone is effective in reducing the rates of arthralgia-myalgia syndrome after an iron dextran infusion 18.…”

“…Premedications with methylprednisolone and an H 2 blocker before IV iron infusions are typically reserved for those patients who suspected to be at an increased risk of an allergic or infusion reaction, including patients with asthma or more than 1 drug allergy 17,18. A prior retrospective study of patients with inflammatory arthritis demonstrated that the premedication with methylprednisolone is effective in reducing the rates of arthralgia-myalgia syndrome after an iron dextran infusion 18. In addition, Barton et al found that 87% of 135 patients with iron-deficiency anemia unresponsive to oral supplementation had no reaction to iron dextran infusion when premedicated with diphenhydramine, cimetidine, and dexamethasone 17.…”