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Long-term safety of vedolizumab for inflammatory bowel disease

  • Loftus, Edward V;
  • Feagan, Brian G;
  • Panaccione, Remo;
  • Colombel, Jean-Frederic;
  • Sandborn, William J;
  • Sands, Bruce E;
  • Danese, Silvio;
  • D'Haens, Geert;
  • Rubin, David T;
  • Shafran, Ira;
  • Parfionovas, Andrejus;
  • Rogers, Raquel;
  • Lirio, Richard A;
  • Vermeire, Severine; 3938;
Publication Date
Sep 02, 2020
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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). / status: published

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