Infliximab and Upadacitinib Demonstrate Superior Early Onset of Efficacy in Biologic-Naïve Ulcerative Colitis With Severe Endoscopic Disease.

In 30 seconds

This post hoc analysis pooled individual participant-level data from 11 randomized controlled trials to compare onset and induction efficacy of advanced therapies in biologic-naïve patients with ulcerative colitis and severe endoscopic disease (Mayo endoscopic score 3). Among 1,781 patients, week-2 PRO-2 response was highest with infliximab (35.1%) and upadacitinib (32.4%). These therapies also had the highest postinduction PRO-2 response rates, at 72.2% and 59.5%, respectively. Patients with severe rather than moderate endoscopic disease had lower response odds for several therapies.

Key findings

• At week 2, PRO-2 response rates were 35.1% with infliximab and 32.4% with upadacitinib, the highest among therapies studied.
• Versus placebo, adjusted odds of early response were highest with upadacitinib (adjusted odds ratio: 6.38 [95% CI: 2.11-19.23], P = 0.001) and infliximab (adjusted odds ratio 4.49 [95% CI: 2.05-9.85], P < 0.001).
• Postinduction PRO-2 response rates were 72.2% with infliximab and 59.5% with upadacitinib.
• Compared with MES 2, MES 3 was associated with reduced early and postinduction response odds for several therapies, particularly ustekinumab, tofacitinib, vedolizumab, and mirikizumab.

Why it matters

The analysis highlights that speed and likelihood of symptom response may differ across advanced therapies in biologic-naïve patients with severe endoscopic disease. It also suggests that baseline endoscopic severity may influence response across treatments. These findings can inform interpretation of comparative efficacy, while recognizing that the analysis is post hoc and does not establish a definitive treatment ranking.

What to keep in mind

This was a post hoc analysis of trial data, and comparisons across therapies were not described as a head-to-head randomized trial.