Ulcerative colitis: safety and efficacy of vedolizumab vs adalimumab

  • Sands BE & al.
  • N Engl J Med
  • 26 Sep 2019

  • curated by Sarfaroj Khan
  • UK Clinical Digest
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Takeaway

  • In patients with moderate-to-severe active ulcerative colitis (UC), vedolizumab was superior to adalimumab in achieving clinical remission and endoscopic improvement.
  • However, corticosteroid-free clinical remission was higher in the adalimumab group vs vedolizumab group.

Why this matters

  • Biologic therapies are widely used in patients with UC, but there is lack of head-to-head trials of these therapies in patients with inflammatory bowel disease.

Study design

  • VARSITY trial randomly assigned 769 patients with UC (age, 18-85 years) to receive intravenous vedolizumab (n=383) and subcutaneous adalimumab (n=386) during 2015-2019.
  • Main outcome: clinical remission, endoscopic improvement and corticosteroid-free remission at week 52.
  • Funding: Takeda.

Key results

  • At week 52, vedolizumab vs adalimumab group showed higher rates of:
    • clinical remission: (31.3% vs 22.5%; difference, 8.8 [95% CI, 2.5-15.0] percentage points; P=.006),
    • endoscopic improvement (39.7% vs 27.7%; difference, 11.9 [95% CI, 5.3-18.5] percentage points; P<.001>
  • Corticosteroid-free clinical remission was lower in vedolizumab vs adalimumab group (12.6% vs 21.8%; difference, −9.3 [95% CI, −18.9 to 0.4] percentage points).
  • Vedolizumab vs adalimumab had lower exposure-adjusted incidence rates of:
    • infection: 23.4 vs 34.6 events per 100 patient-years.
    • serious infection: 1.6 vs 2.2 events per 100 patient-years.
  • Patients treated with vedolizumab had a lower percentage of adverse events and serious adverse events than those treated with adalimumab (62.7% vs 69.2% and 11.0% vs 13.7%, respectively).

Limitations

  • Corticosteroid tapering can vary among practitioners.