PREDICT-UCUC · Acute severe colitis
Intensified versus standard dose infliximab induction therapy for steroid-refractory acute severe ulcerative colitis (PREDICT-UC): an open-label, multicentre, randomised controlled trial
Choy MC, et al.
Lancet Gastroenterol Hepatol 2024 · PMID 39236736 (PubMed, opens in a new tab) · doi 10.1016/S2468-1253(24)00200-0 (full paper, opens in a new tab)
| Endpoint | 10 mg/kg | 5 mg/kg, pooled | Accelerated | Standard | Difference |
|---|---|---|---|---|---|
| Clinical response by day 7, First dose 10 vs 5 mg/kg (primary endpoint) | 65% (30/46) | 61% (56/92) | not in this comparison | not in this comparison | Risk ratio adjusted for thiopurine history 1.06 (95% CI 0.94–1.20); P=0.32 |
| Clinical response, Day 14 | 74% (34/46) | not in this comparison | 73% (35/48) | 68% (30/44) | P=0.81 |
| Clinical remission, Month 3 | 50% (23/46) | not in this comparison | 52% (25/48) | 48% (21/44) | P=0.92 |
| Colectomy, By month 3 · lower is better | 7% (3/45) | not in this comparison | 19% (9/47) | 12% (5/43) | P=0.20 |
No regimen separated from standard dosing at any time point.
Source: Choy 2024, abstract (intention to treat). Comparisons after day 7 were exploratory.
Structured abstract
BackgroundInfliximab rescue therapy for steroid-refractory acute severe UC was standard, but whether a higher first dose or an accelerated schedule improves on standard dosing was unknown.
MethodsOpen-label, multicentre randomised controlled trial at 13 Australian tertiary hospitals, with two randomisations. 138 patients. Primary endpoint: Clinical response by day 7 (Lichtiger score below 10 with a fall of ≥3 points, less rectal bleeding, and ≤4 stools per day).
ResultsPrimary result. 65% (30/46) with 10 mg/kg vs 61% (56/92) with 5 mg/kg; P=0.62; risk ratio adjusted for thiopurine history 1.06 (95% CI 0.94–1.20), P=0.32
Take-homeIn steroid-refractory acute severe UC, a 10 mg/kg first infliximab dose or an accelerated schedule was not better than standard 5 mg/kg dosing.
| Patients | 138 |
|---|---|
| Population | Adults with IV steroid-refractory acute severe UC |
| Comparison | First infliximab dose 10 mg/kg vs 5 mg/kg (1:2). The 5 mg/kg group was re-randomised to standard (weeks 0, 2, 6) or accelerated (weeks 0, 1, 3) induction; the 10 mg/kg group got a second dose by day 7. |
| Drugs | infliximab |
| Classes | Anti-TNF |
| Published | Choy MC, et al. Lancet Gastroenterol Hepatol 2024;9:981–96. |
Key points
- Day 14 response: 74% (intensified), 73% (accelerated) and 68% (standard); P=0.81.
- Month 3: clinical remission 50%, 52% and 48% (P=0.92); colectomy 7%, 19% and 12% (P=0.20).
- Two patients in the 10 mg/kg group had colectomy in the first 7 days vs none in the 5 mg/kg group (P=0.21).
- Infectious adverse events (day 8 to month 3): 4%, 17% and 18% (P=0.082). No deaths.
Limitations
- Open-label and small, and not powered for colectomy.
- The standard arm allowed an extra 5 mg/kg dose between days 3 and 7 for non-response, so it was not a pure fixed-schedule comparison.
- Comparisons of the three regimens after day 7 were exploratory.
Commentary
Why it matters. Many centres use intensified or accelerated infliximab in acute severe UC because inflamed colons with protein loss clear the drug faster. PREDICT-UC tested that practice in a randomised trial and found no clear benefit.
Caveat. The trial was small, and a pragmatic extra dose was allowed in the standard arm. A Bayesian meta-analysis of infliximab intensification in acute severe UC was published in 2026 (PMID 42030468). Local protocols still vary.
Related. CONSTRUCT (PMID 27595142) and CYSIF (PMID 23063316) compare infliximab with ciclosporin.
Journal club
Design
Open-label, multicentre randomised controlled trial at 13 Australian tertiary hospitals, with two randomisations. 138 patients.
Primary result. 65% (30/46) with 10 mg/kg vs 61% (56/92) with 5 mg/kg; P=0.62; risk ratio adjusted for thiopurine history 1.06 (95% CI 0.94–1.20), P=0.32
Validity and applicability
- Open-label and small, and not powered for colectomy.
- The standard arm allowed an extra 5 mg/kg dose between days 3 and 7 for non-response, so it was not a pure fixed-schedule comparison.
- Comparisons of the three regimens after day 7 were exploratory.
Where it sits now
In steroid-refractory acute severe UC, a 10 mg/kg first infliximab dose or an accelerated schedule was not better than standard 5 mg/kg dosing.
- ACTIVE (2025): After a steroid-responsive episode of acute severe UC in a thiopurine- and biologic-naive patient, starting infliximab plus azathioprine reduced 1-year treatment failure compared with azathioprine alone.
- TACOS (2024): Adding tofacitinib to IV steroids improved day-7 response in acute severe UC in one small single-centre trial; promising, but not yet standard care.
- CONSTRUCT (2016): In steroid-refractory acute severe UC, infliximab and ciclosporin are equally effective rescue therapies; choose by local experience, patient factors and the maintenance plan.
- CYSIF (2012): Ciclosporin and infliximab perform similarly as rescue therapy for steroid-refractory acute severe UC, in the short and long term.
Questions for discussion
- The standard arm could have an extra dose for early non-response. Does that make it a fair test of standard dosing?
- The trial was not powered for colectomy. How should you read the numerically higher colectomy rate with the accelerated schedule?
- Would this trial change how you dose infliximab for a patient with very severe colitis and a low albumin?