ArticleMedicine and pharmacy reports2021
Real-life burden of adverse reactions to biological therapy in inflammatory bowel disease: a single-centre prospective case series.
Article in Medicine and pharmacy reports, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers.
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Who cites it
7 citing papers in PubMed, 9 citations in OpenAlex.
- Efficacy and Safety of Anthocyanin-Rich Extract in Patients with Ulcerative Colitis: A Randomized Controlled Trial.Nutrients · 2024Trial
- Effectiveness of Sulfasalazine Therapy Following Mesalazine Treatment Failure in Children with Ulcerative Colitis.Pediatric gastroenterology, hepatology & nutrition · 2026Article
- Real‑world safety and efficacy of biological agents in inflammatory bowel disease: a one-year post-marketing pharmacovigilance observational study in the Calabria region.Pharmacological reports : PR · 2025Observational
- Pathophysiological Links Between Inflammatory Bowel Disease and Cardiovascular Disease: The Role of Dysbiosis and Emerging Biomarkers.Biomedicines · 2025Review
- Mapping the Evolution of IBD Treatment: A Bibliometric Study on Biologics and Small Molecules.Pharmaceuticals (Basel, Switzerland) · 2025Article
- Biologics for Inflammatory Bowel Disease in Clinical Practice: A Calabria (Southern Italy) Prospective Pharmacovigilance Study.Pharmaceutics · 2022Article
- Tertiary referral for double balloon enteroscopy in small bowel Crohn's disease: a retrospective assessment of diagnostic impact.Annals of gastroenterologyArticle
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Authors and funding
14 authors at 1 institution in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
BACKGROUND/
aimBiologics 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.
methodsData 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®).
resultsOverall, 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.
conclusionIn 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.
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