O21 Long-term efficacy and safety of filgotinib 200 mg in ulcerative colitis: 5-year interim data from SELECTIONLTE
Why this work is in the frame
A frame that forgets how it found something cannot be audited. These are the routes that admitted this work.
Bibliographic record
Abstract
<h3>Introduction</h3> Filgotinib (FIL), a once-daily, oral, Janus kinase 1 preferential inhibitor, is approved for the treatment of ulcerative colitis (UC). FIL was effective in inducing and maintaining clinical remission and generally well tolerated in the placebo-controlled phase 2b/3 SELECTION trial (NCT02914522).<sup>1</sup> <h3>Methods</h3> The efficacy and safety of continued treatment with FIL 200 mg (FIL200) are being assessed in the open-label, long-term extension (LTE) study (SELECTIONLTE: NCT02914535). The study design of SELECTION has been published previously.<sup>1</sup> This interim analysis reports the efficacy and safety of open-label FIL200 for up to 5 years of treatment: LTE week 192 in completers (who completed SELECTION induction and maintenance studies) and LTE week 240 in induction non-responders (those with no response at SELECTION week 10). The data cut-off of 23 March 2023 was used for this interim analysis. Proportions of patients with partial Mayo Clinic Score (pMCS) remission (pMCS ≤1) and Inflammatory Bowel Disease Questionnaire (IBDQ) remission (score ≥170) were reported both as observed data and with non-responder imputation (NRI). Adverse events (AEs) and AEs of special interest (AESIs) were evaluated as exposure-adjusted incidence rates per 100 patient-years of exposure (PYE). <h3>Results</h3> This analysis included 148 completers and 372 non-responders. AEs and AESIs in patients receiving open-label FIL200 (2464.7 PYE) showed no new safety signals; safety events were similar to those from previous analyses. Proportions of patients in pMCS remission increased with FIL200 in SELECTION to 72.4% (as observed) at week 58/LTE baseline, and increased further for completers in SELECTIONLTE (85.0% at LTE week 192). Proportions in pMCS remission increased gradually in SELECTIONLTE to 66.7% (FIL200–FIL200, as observed) at LTE week 240 in non-responders. Similar patterns were seen for IBDQ remission; 78.5% (FIL200, as observed) of completers had IBDQ remission at week 58/LTE baseline, increasing to 84.8% by LTE week 192. In non-responders, increases in proportions of patients in IBDQ remission were gradual, up to 77.8% (FIL200–FIL200, as observed) at LTE week 240. NRI analyses showed similar but more conservative results than observed analyses for both groups for both endpoints. <h3>Conclusions</h3> FIL200 was effective in maintaining symptomatic remission and health-related quality of life for up to 5 years. No new safety signals were identified, and rates of AEs with long-term FIL exposure were similar to those previously reported.<sup>1 2</sup> Prolonged treatment with filgotinib is efficacious for the long-term management of UC, and together with its proven safety profile, results in an acceptable benefit–risk profile. <h3>References</h3> Feagan BG, <i>et al. Lancet</i> 2021;<b>397</b>:2372–84. Feagan BG, <i>et al. J Crohns Colitis.</i> 2023;<b>17</b>(Suppl1):i47–50.
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Full frame distilled prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. Learned from the 10,348 direct Codex labels and 10,348 direct Gemma labels. Candidate is the union of thresholded teacher heads; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels or direct frontier model labels.
Codex and Gemma teacher scores by category
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.000 | 0.000 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.000 | 0.000 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.000 | 0.000 |
| Insufficient payload (model declined to judge) | 0.000 | 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 it