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Original article
The safety of vedolizumab for ulcerative colitis and Crohn's disease
  1. Jean-Frédéric Colombel1,
  2. Bruce E Sands1,
  3. Paul Rutgeerts2,
  4. William Sandborn3,
  5. Silvio Danese4,
  6. Geert D'Haens5,
  7. Remo Panaccione6,
  8. Edward V Loftus Jr7,
  9. Serap Sankoh8,
  10. Irving Fox8,
  11. Asit Parikh8,
  12. Catherine Milch8,
  13. Brihad Abhyankar9,
  14. Brian G Feagan10
  1. 1Division of Gastroenterology, Icahn School of Medicine at Mount Sinai Hospital, New York, New York, USA
  2. 2Division of Gastroenterology, Katholieke Universiteit and University Hospital Gasthuisberg, Leuven, Belgium
  3. 3Division of Gastroenterology, University of California San Diego and UC San Diego Health System, La Jolla, California, USA
  4. 4Department of Gastroenterology, Istituto Clinico Humanitas, Milan, Italy
  5. 5Department of Gastroenterology, Academic Medical Center, Amsterdam, The Netherlands
  6. 6Department of Medicine, University of Calgary, Calgary, Alberta, Canada
  7. 7Division of Gastroenterology and Hepatology, Mayo Clinic, Rochester, Minnesota, USA
  8. 8Takeda Pharmaceuticals International Co., Cambridge, Massachusetts, USA
  9. 9Takeda Global Research and Development Centre (Europe) Ltd., London, UK
  10. 10Department of Medicine, Robarts Clinical Trials, Robarts Research Institute, University of Western Ontario, London, Ontario, Canada
  1. Correspondence to Professor Jean-Frédéric Colombel, Division of Gastroenterology, Inflammatory Bowel Disease Center, Icahn School of Medicine, Mount Sinai Hospital, 17 East 102nd Street, 5th Floor, New York, NY 10029, USA; jean-frederic.colombel{at}


Objective Vedolizumab is a gut-selective antibody to α4β7 integrin for the treatment of ulcerative colitis (UC) and Crohn's disease (CD). We report an integrated summary of the safety of vedolizumab.

Design Safety data (May 2009–June 2013) from six trials of vedolizumab were integrated. Adverse events were evaluated in patients who received ≥1 dose of vedolizumab or placebo and were reported as exposure-adjusted incidence rates as the number of patients experiencing the event per 100 person-years (PYs) of exposure. Predictors of serious infection were assessed using a Cox proportional hazards model.

Results In total, 2830 patients had 4811 PYs of vedolizumab exposure (median exposure range, 1–1977 days). No increased risk of any infection or serious infection was associated with vedolizumab exposure. Serious clostridial infections, sepsis and tuberculosis were reported infrequently (≤0.6% of patients). No cases of progressive multifocal leucoencephalopathy were observed. Independent risk factors for serious infection in UC were prior failure of a tumour necrosis factor α antagonist (HR, 1.99; 95% CIs 1.16 to 3.42; p=0.0122) and narcotic analgesic use (HR, 2.68; 95% CI 1.57 to 4.58; p=0.0003), and in CD were younger age (HR, 0.97; 95% CI 0.95 to 0.98; p<0.0001), corticosteroid (HR, 1.88; 95% CI 1.35 to 2.63; p=0.0002) or narcotic analgesic use (HR, 2.72; 95% CI 1.90 to 3.89; p<0.0001). Investigator-defined infusion-related reactions were reported for ≤5% of patients in each study. Eighteen vedolizumab-exposed patients (<1%) were diagnosed with a malignancy.

Conclusions Vedolizumab has a favourable safety profile with low incidence rates of serious infections, infusion-related reactions and malignancies over an extended treatment period.

Trial registration number NCT01177228, NCT00619489, NCT00783718, NCT00783692, NCT01224171, NCT00790933.


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