Cited by 29Inflammatory Bowel DiseaseRheumatoid Arthritis Research and TherapiesPharmacovigilance and Adverse Drug Reactions

Long-term safety of approved biologics for ulcerative colitis

D’Amico, Ferdinando, Parigi, Tommaso Lorenzo, Bonovas, Stefanos, Peyrin-Biroulet, Laurent, Danese, Silvio·2020·Expert Opinion on Drug Safety

Abstract

INTRODUCTION: Ulcerative colitis (UC) is a type of inflammatory bowel disease (IBD) affecting the large intestine and carrying a heavy burden of morbidity for patients. Conventional treatment is based on mesalamine, corticosteroids, and immunosuppressants. In the last two decades, biologic therapies have revolutionized the treatment of UC, increasing the number of therapeutic options and providing better disease control. AREAS COVERED: Most biologics have been approved in recent years and long-term data are still scarce. The aim of this review is to summarize safety data on long-term use of biologics in ulcerative colitis. The authors searched the literature up to May 2020 for studies assessing biological drugs' safety in UC with a follow-up longer than one year and present the key findings. EXPERT OPINION: Biologics long-term safety is consistent with what expected from shorter term studies and no main new concerns emerged from longer follow-up. Real world experience is consistent with clinical trials data. Although comparisons are difficult, safety profiles are not equal among different biologics.

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Crossref · 10.1080/14740338.2020.1773430

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47 of 47 references verified0 citation errors · 0 not checkable

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Authors
D’Amico, F., Parigi, T. L., Bonovas, S., Peyrin-Biroulet, L., & Danese, S.
Affiliations
  • Humanitas University (IT)
  • Department of Gastroenterology and Inserm NGERE U1256, University Hospital of Nancy, University of Lorraine, Vandoeuvre-lès-Nancy, France
Corresponding author
Danese, Silvio
Venue
Expert Opinion on Drug Safety
Published
2020-06-08
Volume
19
Issue
7
Pages
807-816
ISSN
  • 1474-0338 (ISSN-L)
  • 1744-764X
OpenAlex
W3027483667
Cited by
29
References
47
Citations by year
2026: 2 · 2025: 10 · 2024: 6 · 2023: 4 · 2022: 4 · 2021: 3
FWCI
0.39
Type
journal article
Language
en
Open access
closed
Locations
  • Expert Opinion on Drug Safety (publishedVersion)
  • PubMed (publishedVersion)
  • Archivio Istituzionale della Ricerca - Università Vita-Salute San Raffaele (submittedVersion)
Topics
  • Life Sciences › Biochemistry, Genetics and Molecular Biology › Genetics › Inflammatory Bowel Disease
  • Health Sciences › Medicine › Rheumatology › Rheumatoid Arthritis Research and Therapies
  • Life Sciences › Pharmacology, Toxicology and Pharmaceutics › Toxicology › Pharmacovigilance and Adverse Drug Reactions
Keywords
ulcerative colitis, biologic therapy, long-term drug safety, inflammatory bowel disease, TNF-alpha inhibitors, safety profile, real-world evidence, 5-aminosalicylic acid, corticosteroids, immunosuppressants
MeSH terms
Anti-Inflammatory Agents, Biological Products, Colitis, Ulcerative, Humans, Time Factors

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