P685 Improvement in patient-reported Inflammatory Bowel Disease Questionnaire outcomes, and relationship with disease activity, in tofacitinib-treated patients with ulcerative colitis: Data from the OCTAVE clinical trials
Bibliographic record
Abstract
Tofacitinib is an oral, small-molecule JAK inhibitor approved in several countries for the treatment of ulcerative colitis (UC). We assessed relationships between patient (pt)-reported Inflammatory Bowel Disease Questionnaire (IBDQ) outcomes and Mayo score (a widely used measure of clinical activity) in tofacitinib UC induction and maintenance studies. We analysed patients from two randomised, placebo-controlled, 8-week tofacitinib induction studies (OCTAVE Induction 1 and 2, NCT01465763 and NCT01458951) and a 52-week, randomised, placebo-controlled maintenance study (OCTAVE Sustain, NCT01458574). We evaluated IBDQ remission (total score ≥190) and response (≥30-point increase from baseline) at Week 8 (induction) and Weeks 24 and 52 (maintenance). These criteria are more stringent vs. previously reported IBDQ remission (total score ≥170) and response (≥16-point increase from baseline) thresholds. We evaluated relationships between IBDQ total scores and total Mayo scores at baseline and Week 8 (induction) and Weeks 24 and 52 (maintenance) using Spearman correlation. In OCTAVE Induction 1 and 2, mean baseline IBDQ total score of each treatment ranged from 117.5 to 124.9. Statistically significant effects of treatment with tofacitinib 10 mg twice daily (BID) vs. placebo were observed at Week 8 for IBDQ remission (p < 0.05) and response (p < 0.0001) (Table 1). In OCTAVE Sustain, mean baseline IBDQ total score of each treatment ranged from 181.3 to 182.3. There were statistically significant maintenance treatment effects with 5 and 10 mg BID vs. placebo for IBDQ remission and response at Weeks 24 and 52 (all p < 0.0001; Table 2). Spearman correlation coefficients between IBDQ total score and total Mayo score in OCTAVE Induction 1 and 2 at Week 8 were −0.67 and −0.59, respectively. In OCTAVE Sustain, correlation coefficients were −0.57 at Week 24 and −0.40 at Week 52. For patients with moderate to severe UC, induction and maintenance therapy with tofacitinib resulted in statistically significant improvements in patient-reported quality of life vs. placebo, as measured using comparatively stringent IBDQ criteria. Moderate correlations between IBDQ and Mayo scores were observed from Week 8 in OCTAVE Induction to Week 52 in OCTAVE Sustain.
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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 | 0.007 | 0.007 |
| Meta-epidemiology (narrow) | 0.001 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.002 |
| Bibliometrics | 0.000 | 0.001 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.001 | 0.001 |
| Insufficient payload (model declined to judge) | 0.002 | 0.000 |
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".