Real-World Vedolizumab: Better Than Expected

Two recent studies indicate that vedolizumab is performing better than expected in the “real world.”

  • JL Koliani-Pace et al. Inflamm Bowel Dis 2019; 25: 1854-61
  • DM Faleck et al. Clin Gastroenterol Hepatol 2019; 17: 2497-2505.

In the first study, the researchers used 2 data sets (VICTORY cohort, n=1087, & the Truven cohort, n=2574)  to compare vedolizumab in two separate eras; the early era was May 2014-June 2015  and the later era was July 2015-June 2017.

Key findings:

  • Patients with Crohn’s disease (CD) in the VICTORY cohort during the second era had better clinical remission rates: 40% vs 31% and better mucosal healing rates 58% vs 42%
  • Later era patients with ulcerative colitis (UC) in the Truven database had lower rates of IBD-related hospitalization (22.4% vs. 9.6%) and surgery (17.2% vs. 9.4%)
  • In the later era, patients were more likely to be biologic naive.

This study indicates that, overall, patients treated in the first era were likely more sick and less likely to respond to vedolizumab.  The authors’ note that this could be a ‘warehouse effect’ whereby “patients treated within the first year of a drug’s approval are likely representative of a select group of high-risk patients who are refractory to currently available therapies and are being warehoused on ineffective and undesirable therapies (ie. chronic steroid) to bridge them through until a promising agent is approved by the FDA.”

In the second study, the authors retrospectively examined 650 patients with CD and 437 with UC who were treated between 2014-16.  Patients who had a more recent diagnosis of CD (≤2 years) fared better than those with more long-standing disease.

Key findings:

  • Early-stage CD vs. later-stage CD clinical remission rates: 38% vs 23%
  • Early-stage CD vs. later-stage CD with corticosteroid-free remission: 43% vs 14%
  • Early-stage CD vs. later-stage CD with endoscopic remission: 29% vs. 13%
  • UC disease duration did not associate with response to vedolizumab

My take: Taken together, these studies indicate that vedolizumab in the real world may outperform the results of the landmark studies which helped garner FDA approval.  In patients who are less sick and have not been considered refractory to multiple treatments, response rates to vedolizumab are higher.

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7 thoughts on “Real-World Vedolizumab: Better Than Expected

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