Immediate Hypersensitivity Reactions to Biologic Drugs in Children with Inflammatory Bowel Diseases

Int Arch Allergy Immunol. 2025;186(2):142-149. doi: 10.1159/000540795. Epub 2024 Sep 4.

Abstract

Introduction: The increased use of biologic drugs (BDs) may lead to an increase in immediate hypersensitivity reactions (I-HSRs) in pediatric patients with inflammatory bowel disease (IBD). Our aim was to assess I-HSRs to BDs in pediatric IBD, examining frequency, clinical features, management, and associated risk factors.

Methods: All children diagnosed with IBD at our institution between January 1, 2006, and August 1, 2023, and who developed I-HSRs related to any BD were included in the study.

Results: In a study of 197 pediatric IBD patients, 61 used BD. Among these, 52.4% were male, with a median diagnosis age of 145 months (13-215). Out of a total of 1,679 administrations, 6 patients developed I-HSRs (5 with infliximab, 1 with adalimumab), resulting in a frequency of 9.8% per patient and 0.36% per administration. Of these, 66.7% were cases of Type 1 HSRs (skin test positivity n = 1), while the rest were infusion-related reactions (anti-drug antibody positivity n = 4), all of which were mild to moderate in severity. In the age and gender-adjusted logistic regression model, the presence of any comorbid allergic disease was significantly associated with the occurrence of I-HSR (aOR = 8.35; 95% CI = 1.24-56.38; p = 0.029).

Conclusion: The frequency of I-HSRs to BDs in children with IBD is not rare but not severe in the long term. The presence of any comorbid allergic disease is a risk factor for the development of I-HSRs to BDs.

Keywords: Biologics; Children; Hypersensitivity; Inflammatory bowel diseases.

MeSH terms

  • Adolescent
  • Biological Products* / adverse effects
  • Biological Products* / therapeutic use
  • Child
  • Child, Preschool
  • Drug Hypersensitivity* / diagnosis
  • Drug Hypersensitivity* / epidemiology
  • Drug Hypersensitivity* / etiology
  • Female
  • Humans
  • Hypersensitivity, Immediate* / diagnosis
  • Hypersensitivity, Immediate* / epidemiology
  • Hypersensitivity, Immediate* / etiology
  • Inflammatory Bowel Diseases* / drug therapy
  • Inflammatory Bowel Diseases* / epidemiology
  • Male
  • Retrospective Studies
  • Risk Factors

Substances

  • Biological Products