Open AccessReal-life burden of adverse reactions to biological therapy in inflammatory bowel disease: a single-centre prospective case series
Author(s) -
Tiziana Larussa,
Antonio Basile,
Caterina Palleria,
Chiara Iannelli,
Anna Vero,
L. Giubilei,
Caterina De Sarro,
Evelina Suraci,
R. Marasco,
Maria Imeneo,
Emilio Russo,
Ludovico Abenavoli,
Giovambattista De Sarro,
Francesco Luzza
Publication year - 2021
Publication title -
medicine and pharmacy reports
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.35
H-Index - 16
eISSN - 2668-0572
pISSN - 2602-0807
DOI - 10.15386/mpr-1897
Subject(s) - medicine , meddra , discontinuation , ulcerative colitis , inflammatory bowel disease , infliximab , prospective cohort study , medical prescription , adverse effect , crohn's disease , disease , pharmacovigilance , pharmacology
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.