P690 Prolonged benefit of filgotinib in patients with Ulcerative Colitis in SELECTION
Laharie, D.(1)*;Sturm, A.(2);Kobayashi, T.(3);Matsumoto, T.(4);Oortwijn, A.(5);Jamoul , C.(6);Faes, M.(6);de Haas, A.(7);Vermeire , S.(8);
(1)Hospital Haut-Leveque, Department of Gastroenterology and Hepatology, Pessac, France;(2)DRK Kliniken Berlin Westend, Department of Internal Medicine and Gastroenterology, Berlin, Germany;(3)Center for Advanced IBD Research and Treatment, Kitasato University- Kitasato Institute Hospital, Toyko, Japan;(4)Iwate Medical University, Division of Gastroenterology- Department of Medicine, Morioka, Japan;(5)Galapagos NV, Medical Affairs Department, Leiden, The Netherlands;(6)Galapagos NV, Biostatistics Department, Mechelen, Belgium;(7)Galapagos NV, Clinical Development Department, Leiden, The Netherlands;(8)University Hospitals Leuven, Department of Gastroenterology and Hepatology, Leuven, Belgium;
Background
Filgotinib (FIL) is a once-daily, oral, Janus kinase 1 preferential inhibitor approved for the treatment of patients with ulcerative colitis (UC) in the UK, EU and Japan. In the phase 2b/3 SELECTION trial (NCT02914522),1 FIL 200 mg (FIL200) was well tolerated and effective in inducing and maintaining clinical remission vs placebo (PBO) in patients with UC. This post hoc analysis of SELECTION data further evaluated the prolonged benefit of FIL treatment from week 10 (W10) until W58.
Methods
In SELECTION, adults with moderately to severely active UC were randomized 2:2:1 to receive FIL200, FIL 100 mg (FIL100) or PBO once daily for 11 weeks in Induction (IND) Studies A and B (biologic-naïve and -experienced patients, respectively). Patients in clinical remission or with a Mayo Clinic Score (MCS) response at W10 (responders) were rerandomized 2:1 to continue their IND FIL dose in the 47-week Maintenance (MNT) Study. This post hoc analysis evaluated the hazard ratio (HR) for protocol-specified disease worsening (PSDW) in patients who continued FIL200 during MNT (FIL200→FIL200) vs those rerandomized from FIL200 to PBO (FIL200→PBO). The proportion of patients with a prolonged benefit at W58 was also evaluated across all FIL200 and FIL100 MNT arms. A prolonged benefit was defined as clinical remission or an MCS response at W58, among W10 responders. Among patients with prolonged benefit at W58, the proportion of those who had Inflammatory Bowel Disease Questionnaire (IBDQ)-remission at W58 was also assessed across all FIL200 and FIL100 MNT arms.
Results
Baseline characteristics were similar between MNT arms, although biologic-experienced status was more common in patients who did not have a prolonged benefit vs those who did. FIL200→FIL200 treatment (n=199) reduced the risk of PSDW by 74% vs FIL200→PBO (n=98) (HR [95% CI]: 0.26 [0.17–0.40]; p<0.0001) (Figure 1). PSDW was the most common reason for discontinuation among patients without prolonged benefit, across all arms. In the FIL200→FIL200 arm, 66.8% of patients who were in clinical remission or had an MCS response at W10 had a prolonged benefit at W58 vs 32.7% in the FIL200→PBO arm. Among patients in clinical remission at W10, 79.3% in the FIL200→FIL200 arm had a prolonged benefit (62.1% clinical remission; 17.2% MCS response) vs 44.4% in the FIL200→PBO arm (30.6% clinical remission; 13.9% MCS response) (Figure 2). In the FIL200→FIL200 arm, 82.0% of patients with prolonged benefit at W58 had IBDQ remission at W58 (Figure 3).
Conclusion
After a year of FIL200 treatment, two-thirds of patients who were in clinical remission or had an MCS response at W10, and ~80% who were in clinical remission at W10, had a prolonged benefit.
1. Feagan BG et al. Lancet 2021;397:2372–84.