Infliximab at 5 years: EU OPUS registry finds no new safety signal in UC

  • J Crohns Colitis

  • curated by Emily Willingham, PhD
  • Clinical Essentials
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Takeaway

  • Patients with ulcerative colitis (UC) treated with infliximab (Remicade) have increased serious infection risk vs using conventional therapies.
  • But no new safety signals emerged in this 5-year Observational Postmarketing Ulcerative colitis (OPUS) registry study .
  • The drug already has a black box warning from the FDA.

Why this matters

  • This drug has not been studied in a long-term postmarket safety study in patients with UC.

Key results

  • With infliximab vs conventional therapy:
    • 46.0% had severe disease clinically (partial Mayo score, 7-9) vs 30.5%.
    • 17.6% had severe disease endoscopically vs 12.5%.
    • HR for serious infection: 1.98 (95% CI, 1.34-2.91; P<.001>
  • The groups did not differ in mortality rates or rates for other conditions.

Study design

  • 1180 having conventional therapy were compared with 1059 having originator infliximab in this prospective, nonrandomized observational registry study.
  • Funding: Merck & Co., Inc., Kenilworth, NJ, USA. 

Limitations

  • Other agents have become available during the study, so generalizability to current practice is unclear.