S0779 Effect of Ustekinumab Maintenance Therapy on Stool Frequency and Rectal Bleeding Through 2 Years in the UNIFI Phase 3 Study in Ulcerative Colitis
Bibliographic record
Abstract
INTRODUCTION: The UNIFI randomized-withdrawal maintenance study evaluated the safety & efficacy of subcutaneous (SC) ustekinumab (UST) in patients (pts) with moderately to severely active ulcerative colitis (UC) who had responded to intravenous (IV) UST induction. Pts who completed the maintenance study could enter a long-term extension (LTE) through 220 weeks (wks). We evaluated the effect of UST maintenance therapy on stool frequency & rectal bleeding through 92wks in pts who were treated in the LTE. METHODS: All pts who completed Wk44 were eligible to enter & continue in the LTE at the investigator’s discretion. PBO pts were discontinued from the LTE after maintenance study unblinding. During the LTE, pts were eligible to receive dose adjustment (PBO to q8w or q12w to q8w or q8w to q8w [sham dose adjustment]) starting at Wk56 based on investigator assessment of pts’ UC disease activity. Dose adjustment was considered part of the treatment experience & not considered a treatment failure for these analyses. Pts recorded the number of stools & rectal bleeding symptoms for 7 days before each visit. The proportions of pts with Mayo stool frequency subscores of 0 (normal number of stools) or 1 (1 to 2 stools more than normal) or rectal bleeding subscores of 0 (no blood seen) were evaluated. Absolute stool number was also summarized. RESULTS: Pts who were randomized & treated in the LTE were included in these analyses (UST 90 mg q12w: n = 141; UST 90 mg q8w: n = 143). Absolute stool numbers in the UST q12w and q8w groups were 6.6 and 6.5 stools per day, respectively, at induction baseline (BL) & decreased to 2.8 and 2.7, respectively, by maintenance BL. Reductions achieved at maintenance BL were maintained at Wk92 (2.7 & 2.2, respectively). At induction BL, only 12.8% & 18.2% of pts, respectively, had Mayo stool frequency subscores of 0 or 1. By maintenance BL, 80.9% & 80.4%, respectively, had Mayo stool frequency subscores of 0 or 1, & these percentages were maintained through Wk92 (79.4% & 86.7% at Wk92, respectively). At induction BL, 9.2% & 7.0%, respectively, had no blood seen in the stool. By maintenance BL, 87.2% & 84.6%, respectively, had no blood seen in the stool, & these percentages were maintained through Wk92 (86.5% & 88.8%). CONCLUSION: Among pts who were treated in the LTE, reductions in stool frequency & rectal bleeding that had been achieved after IV UST induction were maintained through 2 yrs of UST SC maintenance. These data support the durability of response to UST in UC.Table 1
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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 | 0.002 | 0.001 |
| Meta-epidemiology (narrow) | 0.001 | 0.000 |
| Meta-epidemiology (broad) | 0.002 | 0.002 |
| Bibliometrics | 0.000 | 0.001 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.001 | 0.000 |
| Research integrity | 0.001 | 0.002 |
| Insufficient payload (model declined to judge) | 0.011 | 0.002 |
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".