Long-term safety of vedolizumab for inflammatory bowel disease

Edward V Loftus, Brian G Feagan, Remo Panaccione, Jean-Frédéric Colombel, William J Sandborn, Bruce E Sands, Silvio Danese, Geert D'Haens, David T Rubin, Ira Shafran, Andrejus Parfionovas, Raquel Rogers, Richard A Lirio, Séverine Vermeire

Research output: Contribution to journalArticlepeer-review

Abstract

BACKGROUND: Vedolizumab, a gut-selective α4 β7 integrin antibody, is approved for moderately to severely active ulcerative colitis (UC) and Crohn's disease (CD).

AIM: To report the final results from the vedolizumab GEMINI long-term safety (LTS) study.

METHODS: The phase 3, open-label GEMINI LTS study (initiated May 2009) enrolled patients with UC or CD from four prior clinical trials and vedolizumab-naïve patients. Vedolizumab LTS was evaluated; efficacy and patient-reported outcomes were exploratory endpoints.

RESULTS: Enrolled patients (UC, n = 894; CD, n = 1349) received vedolizumab 300 mg IV every 4 weeks; median cumulative exposure was 42.4 months (range: 0.03-112.2) for UC and 31.5 months (range: 0.03-100.3) for CD. Over 8 years, adverse events (AEs) occurred in 93% (UC) and 96% (CD) of patients, with UC (36%) and CD (35%) exacerbations most frequent. Serious AEs were reported for 31% (UC) and 41% (CD) of patients. Vedolizumab discontinuation due to AEs occurred in 15% (UC) and 17% (CD) of patients. There were no new trends for infections, malignancies, infusion-related reactions, or hepatic events, and no cases of progressive multifocal leukoencephalopathy. Of the ten deaths (UC, n = 4; CD, n = 6), two were considered drug-related by local investigators (West Nile virus infection-related encephalitis and hepatocellular carcinoma). Continuous vedolizumab maintained clinical response long-term, with 33% (UC) and 28% (CD) of patients in clinical remission at 400 treatment weeks.

CONCLUSIONS: The safety profile of vedolizumab remains favourable with no unexpected or new safety concerns. These results further establish the safety of vedolizumab and support its long-term use (NCT00790933/EudraCT 2008-002784-14).

Original languageEnglish
Pages (from-to)1353-1365
Number of pages13
JournalAlimentary Pharmacology and Therapeutics
Volume52
Issue number8
DOIs
Publication statusPublished - Oct 2020

Keywords

  • Adult
  • Aged
  • Antibodies, Monoclonal, Humanized/administration & dosage
  • Cohort Studies
  • Colitis, Ulcerative/drug therapy
  • Crohn Disease/drug therapy
  • Drug-Related Side Effects and Adverse Reactions/epidemiology
  • Female
  • Follow-Up Studies
  • Gastrointestinal Agents/administration & dosage
  • Humans
  • Inflammatory Bowel Diseases/drug therapy
  • Male
  • Middle Aged
  • Quality of Life
  • Time Factors
  • Treatment Outcome
  • Young Adult

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