Trial reportAlimentary pharmacology & therapeutics2025
Clinical Trial: Association Between Early Disease Clearance and Long-Term Outcomes-4-Year Results From the Phase 3 UNIFI Study of Ustekinumab in Ulcerative Colitis.
Trial report in Alimentary pharmacology & therapeutics, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02407236 (A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Protocol to Evaluate the Safety and Efficacy of Ustekinumab Induction and Maintenance Therapy in Subjects With Moderately to Severely Active Ulcerative Colitis), which is not on this map. Cited by 3 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Protocol to Evaluate the Safety and Efficacy of Ustekinumab Induction and Maintenance Therapy in Subjects With Moderately to Severely Active Ulcerative Colitis
Who cites it
3 citing papers in PubMed.
- Disease Clearance Reduces the Risk of Adverse Outcomes and Provides Additional Benefit Beyond Individual Clinical, Endoscopic, or Histological Remission in Ulcerative Colitis.Journal of clinical medicine · 2026Article
- Insights From Studies on Ustekinumab: Efficacy, Long-Term Outcomes, and Treatment Persistence in Patients With Ulcerative Colitis.Gastroenterology & hepatology · 2023Article
- Highlights in Ulcerative Colitis From the American College of Gastroenterology 2023 Annual Scientific Meeting: Commentary.Gastroenterology & hepatology · 2023Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
6 authors.
Funding
Abstract
backgroundAchievement of disease clearance (simultaneous symptomatic remission and histo-endoscopic mucosal improvement [HEMI]) following induction therapy may lead to better long-term outcomes in ulcerative colitis (UC).
aimTo evaluate disease clearance in the phase 3 UNIFI program and its association with long-term outcomes.
methodsUNIFI comprised randomised, placebo-controlled induction and maintenance studies and a long-term extension, which evaluated intravenous ustekinumab induction (130 mg or ~6 mg/kg) and subcutaneous ustekinumab maintenance therapy (90 mg every 8 or 12 weeks) through 4 years in patients with UC.
resultsDisease clearance was achieved by 5.9%, 15.2% and 15.1% of patients 8 weeks after placebo or ustekinumab 130 mg or ~6 mg/kg induction, respectively. Among ustekinumab induction responders randomised to ustekinumab maintenance therapy who did or did not achieve disease clearance 8 weeks after induction, 63.6% and 35.2% (nominal p < 0.001), respectively, achieved clinical remission (Mayo score ≤ 2, no individual subscore > 1) at Week 44. Among ustekinumab induction responders randomised to ustekinumab maintenance therapy who achieved disease clearance, symptomatic remission without HEMI, or neither symptomatic remission nor HEMI 8 weeks after induction, 73.4%, 53.5% (nominal p = 0.002) and 45.1% (nominal p < 0.001), respectively, achieved symptomatic remission (Mayo stool frequency subscore 0/1, rectal bleeding subscore 0) and 58.2%, 46.5% (nominal p = 0.09) and 42.7% (nominal p = 0.05), respectively, achieved Inflammatory Bowel Disease Questionnaire remission (score ≥ 170) at Week 200.
conclusionsPatients who achieved disease clearance 8 weeks after ustekinumab induction were more likely to be in long-term clinical, symptomatic and quality of life remission with ustekinumab maintenance treatment than patients who did not.
trial registrationNCT02407236.
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