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