O21 Long-term efficacy and safety of filgotinib 200 mg in ulcerative colitis: 5-year interim data from SELECTIONLTE
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Résumé
<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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Imitation des enseignantsNi prévalence calibrée, ni vérité terrain. Validation humaine à venir. Apprise à partir de 10 348 étiquettes directes de Codex et de 10 348 étiquettes directes de Gemma. Le mode candidate est l'union des têtes enseignantes seuillées; le consensus est leur intersection. Ces sorties portent le statut machine_predicted_unvalidated et ne sont ni des étiquettes humaines ni des étiquettes directes de modèles de pointe.
Scores Codex et Gemma par catégorie
| Catégorie | Codex | Gemma |
|---|---|---|
| Métarecherche | 0,000 | 0,000 |
| Méta-épidémiologie (sens strict) | 0,000 | 0,000 |
| Méta-épidémiologie (sens large) | 0,000 | 0,000 |
| Bibliométrie | 0,000 | 0,000 |
| Études des sciences et des technologies | 0,000 | 0,000 |
| Communication savante | 0,000 | 0,000 |
| Science ouverte | 0,000 | 0,000 |
| Intégrité de la recherche | 0,000 | 0,000 |
| Charge utile insuffisante (le modèle a refusé de juger) | 0,000 | 0,000 |
Scores machine (provisoires)
Les deux têtes enseignantes du modèle étudiant, lues sur ce travail. Un score ordonne la base pour la relecture; il n'affirme jamais une catégorie, et le statut de validation accompagne chaque rangée tel quel.
Scores de référence d'un modèle non mature (critères de maturité non atteints, 7 itérations). Un score ordonne; il n'affirme jamais une catégorie.
score_only:v0-immature-baseline · tel quel depuis la passe de notation : score_only signifie que le nombre peut ordonner les travaux, et qu'aucune étiquette de catégorie n'en découle