Clinical Trial: Association Between Early Disease Clearance and Long‐Term Outcomes—4‐Year Results From the Phase 3 <scp>UNIFI</scp> Study of Ustekinumab in Ulcerative Colitis
Bibliographic record
Abstract
BACKGROUND: Achievement 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). AIM: To evaluate disease clearance in the phase 3 UNIFI program and its association with long-term outcomes. METHODS: UNIFI 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. RESULTS: Disease 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. CONCLUSIONS: Patients 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 REGISTRATION: NCT02407236.
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.005 | 0.004 |
| Meta-epidemiology (narrow) | 0.001 | 0.000 |
| Meta-epidemiology (broad) | 0.002 | 0.002 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.001 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.001 | 0.001 |
| Research integrity | 0.002 | 0.003 |
| Insufficient payload (model declined to judge) | 0.006 | 0.001 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".