麻豆传媒

ORLANDO -- Vedolizumab (Entyvio) and infliximab (Remicade) led to mostly similar 1-year outcomes in patients with ulcerative colitis previously untreated with a biologic, but the integrin receptor antagonist vedolizumab slightly edged out the tumor necrosis factor (TNF) blocker in some areas, according to a real-world dataset.

At 52 weeks, there was no significant difference in clinical remission (82.3% vs 77.4%, respectively) or steroid-free clinical remission (84.8% vs 83.1%), but more patients taking vedolizumab achieved endoscopic remission (47.4% vs 33.1%, P=0.03), Sandro da Costa Ferreira, MD, of Ribeirão Preto Medical School at the University of São Paulo in Brazil, and colleagues reported.

"Both vedolizumab and infliximab are effective in biologic-naive ulcerative colitis patients," the authors concluded in a poster presentation at the Advances in Inflammatory Bowel Diseases meeting. "However, vedolizumab demonstrated superior endoscopic outcomes, higher treatment persistence, and a better safety profile, supporting its use as a first-line therapy."

The two agents are standard initial options for moderate-to-severe disease, but little data exist comparing their efficacy in the real world. No head-to-head trials exist and a prior comparison of the drugs' respective clinical trial data suggested similar rates of clinical remission but a higher likelihood of steroid-free clinical remission and endoscopic remission with infliximab.

For their study, da Costa Ferreira and colleagues conducted a retrospective, multicenter study of 297 patients with moderate-to-severe active ulcerative colitis, defined as having a total Mayo score of 6-12 and an endoscopic score of at least 2. None of the patients had previously received biologics.

The researchers assessed patient outcomes at 12 weeks (post-induction), 26 weeks, and 52 weeks, with 141 patients taking the integrin receptor antagonist vedolizumab and 156 patients taking the TNF blocker infliximab. Only 52-week data were reported at the meeting.

For the primary endpoints, the authors defined clinical remission as a partial Mayo score of 2 or less and endoscopic remission as a Mayo subscore of 0. They also used propensity-score adjustment to correct for bias.

In secondary endpoints, clinical response was not significantly different at 52 weeks between those taking vedolizumab and those taking infliximab (90.7% vs 88.3%). Biochemical remission -- defined as C-reactive protein of no more than 0.5 mg/dL and/or fecal calprotectin of no more than 150 μ/g -- was also no different at that point (42.5% vs 35.1%, respectively).

However, vedolizumab outperformed infliximab in the proportion of patients who had endoscopic response -- an endoscopic Mayo subscore of 0-1 -- and in rates of treatment persistency, with less need for drug optimization:

• Endoscopic response: 78.4% vs 62.7%, respectively (P<0.001)
• Treatment persistency: 80.8% vs 61.8% (P<0.001)
• Drug optimization: 19.2% vs 36.7% (P=0.03)

Need for hospitalization was also substantially and significantly lower for patients on vedolizumab (0.71% vs 9.1% with infliximab, P<0.001). But secondary loss of response was similar between the two groups (15% vs 20.3%).

Incidence of adverse events (AEs) was numerically higher for infliximab than vedolizumab, though the difference was not significant (46.1% vs 34%, P=0.17). Infection rates were also similar between (20.5% vs 15.8%, respectively). More arthralgia occurred with vedolizumab than infliximab (12.1% vs 3.8%) but less infusion reactions (none vs 5.1%)

More serious AEs occurred with infliximab (18.5%) than vedolizumab (6.4%), but significance for this difference was not reported.

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