Long-term safety of vedolizumab for inflammatory bowel disease

Aliment Pharmacol Ther. 2020 Sep 2. doi: 10.1111/apt.16060. Online ahead of print.

Edward V Loftus Jr 1, Brian G Feagan 2, Remo Panaccione 3, Jean-Frédéric Colombel 4, William J Sandborn 5, Bruce E Sands 4, Silvio Danese 6, Geert D'Haens 7, David T Rubin 8, Ira Shafran 9, Andrejus Parfionovas 10, Raquel Rogers 10, Richard A Lirio 10, Séverine Vermeire 11


Author information

  • 1Rochester, MN, USA.
  • 2London, ON, Canada.
  • 3Calgary, AB, Canada.
  • 4New York, NY, USA.
  • 5San Diego, CA, USA.
  • 6Milan, Italy.
  • 7Amsterdam, The Netherlands.
  • 8Chicago, IL, USA.
  • 9Winter Park, FL, USA.
  • 10Cambridge, MA, USA.
  • 11Leuven, Belgium.


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).

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