836 Tofacitinib Efficacy in Patients With Moderate to Severe Ulcerative Colitis: Subgroup Analyses of OCTAVE Induction 1 & 2 and OCTAVE Sustain by 5-Aminosalicylates Use
Bibliographic record
Abstract
INTRODUCTION: Tofacitinib is an oral, small molecule JAK inhibitor for the treatment of ulcerative colitis (UC). The efficacy and safety of tofacitinib were demonstrated in 3 Phase 3 trials (OCTAVE Induction 1 & 2, NCT01465763 & NCT01458951; OCTAVE Sustain, NCT01458574) in patients (pts) with moderate to severe UC (1). In this post-hoc analysis, we explored tofacitinib efficacy for pts with (c5-ASA) and without (n5-ASA) concomitant 5-aminosalicylates use. METHODS: In OCTAVE Induction 1 & 2, pts received placebo (PBO) or tofacitinib 10 mg twice daily (BID) for 8 weeks; clinical responders were re-randomized into OCTAVE Sustain for 52 weeks and received PBO, tofacitinib 5 or 10 mg BID. c5-ASA were permitted at entry, provided doses were stable for ≥4 weeks prior to and during the trials. Remission and mucosal healing were summarized at Week 8 (OCTAVE Induction 1 & 2) and Week 52 (OCTAVE Sustain) by c5-ASA status. Generalized linear models were used to compare adjusted treatment effects between 5-ASA subgroups (Tables 1 and 2). RESULTS: A smaller proportion of c5-ASA pts had prior tumor necrosis factor inhibitor (TNFi) and immunosuppressant failure versus n5-ASA pts, at baseline of OCTAVE Induction and OCTAVE Sustain (OCTAVE Induction 1 & 2: TNFi failure, 42.7% vs 74.5%; immunosuppressant failure, 69.4% vs 78.3%; OCTAVE Sustain: TNFi failure, 36% vs 70%; immunosuppressant failure, 67.9% vs 80%). For both the 5-ASA subgroups, a higher proportion of tofacitinib-treated pts achieved efficacy endpoints, versus PBO-treated pts, at Week 8 of OCTAVE Induction 1 & 2 and Week 52 of OCTAVE Sustain (Tables 1 and 2). Without controlling for baseline variables, higher treatment effects were observed within the c5-ASA subgroup versus the n5-ASA subgroup. When controlled for prior TNFi and immunosuppressant failure (and baseline remission status in OCTAVE Sustain), the differences were not statistically significant in treatment effects between the 5-ASA subgroups in terms of adjusted odds ratios (Tables 1 and 2). CONCLUSION: When controlling for prior UC treatment status, efficacy of tofacitinib, based on adjusted odds ratios, was similar regardless of 5-ASA status. These post-hoc analyses were not intended to evaluate incremental benefit of 5-ASA as combination therapy for tofacitinib.
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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 | 0.003 | 0.004 |
| Meta-epidemiology (narrow) | 0.001 | 0.000 |
| Meta-epidemiology (broad) | 0.003 | 0.009 |
| Bibliometrics | 0.001 | 0.001 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.001 | 0.001 |
| Research integrity | 0.001 | 0.001 |
| Insufficient payload (model declined to judge) | 0.003 | 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".