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ACUTE INFUSION REACTIONS DUE TO DIFFERENT BIOLOGIC AGENTS IN A LARGE COHORT OF PATIENTS WITH INFLAMMATORY BOWEL DISEASE

Ivan Capobianco 1, Stefania Colantuono 2, Cristiano Caruso 2, Gabriele Rumi 2, Valentina Blasi 1, Jacopo Iaccarino 1, Federica Di Vincenzo 1, Pierluigi Puca 1, Fabrizio Termite 1, Gaetano Coppola 2, VALENTIN CALVEZ 2, Laura Parisio 2, Fabiola De Biasio 2, Norma Alfieri 2, Irene Mignini 2, Daniele Napolitano 2, Elisa Schiavoni 2, Lucrezia Laterza 2, Loris Riccardo Lopetuso 2, Daniela Pugliese 2, Marcello Covino 3, Antonio Gasbarrini 2, Franco Scaldaferri 2, Alfredo Papa 2

Affiliations

1 Università Cattolica Del Sacro Cuore, Rome, Italy

2 Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy

3 Fondazione Policlinico Universitario A. Gemelli, IRCCS, Rome, Italy

Summary

AI Generated

A retrospective study of 1911 IBD patients found acute infusion reactions were rare overall (1.1%) but significantly more common with infliximab biosimilars (2.9%) compared to adalimumab (0.7%), vedolizumab (0.6%), and ustekinumab (0%).

Among 22 acute infusion reactions recorded, 16 occurred with infliximab biosimilars, 4 with adalimumab, 2 with vedolizumab, and none with ustekinumab, with differences statistically significant (p<0.01).
Seven of 16 infliximab-related reactions were moderate-severe, including two anaphylaxis episodes in Crohn's disease patients, while all vedolizumab and adalimumab reactions were mild to moderate.
Twelve of 22 reactions occurred during the induction period (first to third administration), and 7 of 22 patients had previous allergic reactions.
Almost all patients who experienced acute infusion reactions subsequently changed to a different biological agent.
The authors conclude that most patients experiencing reactions were atopic and call for further studies to characterize risk profiles for acute infusion reactions.

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This summary was generated by an AI large language model based on the content transcript. It is for informational purposes only and should not be considered a substitute for clinical judgment. Always rely on your professional expertise and the full clinical context when making clinical decisions.

Abstract

Introduction

The therapeutic armamentarium for inflammatory bowel disease (IBD) includes several biological agents: infliximab (IFX), adalimumab (ADA), vedolizumab (VED) and ustekinumab (UST). Persistence in therapy with these drugs is not satisfactory, not only due to the loss of clinical response over time but also due to adverse events. Acute infusion reactions (AIRs) occur during or within 24 hours of the infusion. The intensity of AIRs ranges from mild (flushing, dizziness, headache, itching, rash) to severe (anaphylactic).

Aims & Methods

The primary aim of this study was to compare the prevalence rates of AIRs due to the different biological agents in a large cohort of patients with IBD and to assess risk factors for AIRs.
All reports of AIRs occurring from January 2021 to October 2023 in IBD patients treated with different biological agents (IFX, ADA, VED and UST) in a tertiary IBD center were retrospectively reviewed. The electronic records of the identified patients were checked for the type of IBD, whether Crohn's disease (CD) or ulcerative colitis (UC), type of biological agent, route of administration (intravenous or subcutaneous), concomitant immunosuppressive therapies, atopic status. Furthermore, the type of treatment for the AIRs and the subsequent therapy undertaken for IBD were also recorded.

Results

22 AIRs were recorded out of 1911 patients (1.1%). Of these, 16/550 in patients on IFX biosimilars (2.9 %), 4/590 (0.7%) in patients on ADA biosimilars, 2/318 (0.6%) in patients on VED and 0/453 (0%) in patients on UST (Table 1). The difference in the prevalence of AIR rates observed with the different biological agents was statistically significant (p<0.01). 7 of 16 post-IFX AIRs were moderate-severe, with two episodes of anaphylaxis occurring in patients with CD. The two patients treated with VED experienced only mild symptoms, and no anti-reactive treatment has been used; two mild and two moderate AIRs, respectively, have been reported among patients on ADA. 12 of 22 AIRs occurred during the induction period (from the first to the third administration). 7 of 22 patients had previous allergic reactions.

		Infliximab (n=16)	Adalimumab (n=4)	Vedolizumab (n=2)
Type of IBD, n (%)	Ulcerative colitis	8 (50)	2 (50)	2 (100)
Age, y. Median (range)		34.81 (20-62)	47 (42-50)	62.5 (50-75)
Sex, n (%)	Female	7 (43.8)	2 (50)	0 (0)
Duration of IBD, y. median (range)		6.1 (1-22)	12.2 (7-15)	8.5 (6-11)
AIRs’ severity	Mild	9 (56.2)	4 (100)	2 (100)
AIRs’ severity	Moderate-Severe	7 (43.8)	0 (0)	0 (0)
Infusion number, (when AIR occurred) n (%)	1-3	10 (62.5)	1 (25)	1 (50)
	4-7	5 (31.25)	0 (0)	1 (50)
	>7	1 (6.25)	3 (75)	0 (0)

Conclusion

Our real-world data on a large population of IBD patients treated with biologic agents confirm that AIRs are rare and occur mainly in patients treated with IFX biosimilars. Most patients who experienced AIRs were atopic. Almost all patients after AIRs changed biological agents within or out of the same biological class. Further studies are necessary to confirm our results and better characterise the profile of patients at greater risk of AIRs.

Conference

UEG Week Vienna 2024

Topics

IBD

Submission format

Abstract

Session

IBD (Posters)

Citation

United European Gastroenterology Journal 2024; 12 (Supplement 8)

Published

2024

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