Real-life burden of adverse reactions to biological therapy in inflammatory bowel disease: a single-centre prospective case series

Authors

  • Tiziana Larussa
  • Antonio Basile
  • Caterina Palleria
  • Chiara Iannelli
  • Ada Vero
  • Lidia Giubilei
  • Caterina De Sarro
  • Evelina Suraci
  • Raffaella Marasco
  • Maria Imeneo
  • Emilio Russo
  • Ludovico Abenavoli
  • Giovambattista De Sarro
  • Francesco Luzza

DOI:

https://doi.org/10.15386/mpr-1897

Keywords:

inflammatory bowel disease, adverse drug reactions, TNF inhibitors, pharmacovigilance, drug safety, biological therapy

Abstract

Background/aim. Biologics represent a key therapeutic option in inflammatory bowel disease (IBD), but are associated with several side effects. Post-marketing surveillance, through a spontaneous adverse drug reactions (ADRs) monitoring system, is essential to assess the safety profile of biologics. The aim of the study was to prospectively evaluate the occurrence of ADRs in IBD patients treated with biologics from a single centre in Southern Italy.

Methods. Data from patients with Crohn’s Disease (CD) and Ulcerative Colitis (UC) who underwent biological therapy were prospectively collected. ADRs were classified according to the Medical Dictionary for Regulatory Activities (MedDRA®).

Results. Overall, 68 (54% male, 68% with UC and 32% with CD) biologic-naïve IBD patients underwent biological therapy. Mean follow-up was 11.7 ± 6.2 months. As a results of switches, for 68 patients we obtained 96 biologic prescriptions. Overall, 45 ADRs occurred in 36 (53%) patients, distributed as follows (ADRs/prescriptions): 19/37 with IFX-Remicade, 5/12 with IFX-Remsima, 8/9 with GOL, 11/26 with ADA, and 2/12 with VDZ. Mild ADRs were 29 (64%), moderate 15 (34%) and 1 (2%) severe. General disorders and administration related reactions were the most frequent ADRs (35%), followed by skin and subcutaneous tissue disorders (20%), infections (15%), musculoskeletal (11%), respiratory (6%) blood (4%), gastrointestinal (4%), and vascular disorders (2%). In 9 cases (20%) the ADRs resulted in definitive discontinuation of biologic therapy.

Conclusion. In a prospective cohort of IBD patients, more than half experienced ADRs during biologic therapy. General disorders and administration related reactions were the most common ADRs, while infections were less common and rarely led to discontinuation of therapy. Findings underline the importance of surveillance in management of IBD patients during biologic therapy and implementing safety protocols with data from real-life settings.

Downloads

Published

2021-06-30

How to Cite

1.
Larussa T, Basile A, Palleria C, Iannelli C, Vero A, Giubilei L, De Sarro C, Suraci E, Marasco R, Imeneo M, Russo E, Abenavoli L, De Sarro G, Luzza F. Real-life burden of adverse reactions to biological therapy in inflammatory bowel disease: a single-centre prospective case series. Med Pharm Rep [Internet]. 2021 Jun. 30 [cited 2025 Oct. 28];94(3):289-97. Available from: https://medpharmareports.com/index.php/mpr/article/view/1897

Issue

Vol. 94 No. 3 (2021)

Section

Original Research

License

The authors are required to transfer the copyright of the published paper to the journal. This is done by agreeing to sign the Copyright Assignment Form. Whenever the case, authors are also required to send permissions to reproduce material (such as illustrations) from the copyright holder.

 Creative Commons License
The papers published in the journal are licensed under a Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International License.