P517 Re-treatment with filgotinib in patients with Ulcerative Colitis following treatment interruption: Analysis of the SELECTION and SELECTIONLTE studies
Vermeire, S.(1);Feagan, B.(2,3);Peyrin-Biroulet, L.(4);Oortwijn, A.(5);Faes, M.(6);de Haas, A.(5);Rogler, G.(7);
(1)University Hospitals Leuven, Department of Gastroenterology and Hepatology, Leuven, Belgium;(2)Alimentiv, Inc., London Ontario, Canada;(3)London Health Sciences Centre- Western University, Division of Gastroenterology, London Ontario, Canada;(4)University Hospital of Nancy- University of Lorraine, Department of Gastroenterology, Vandoeuvre-lès-Nancy, France;(5)Galapagos, Nv, Leiden, The Netherlands;(6)Galapagos, Nv, Mechelen, Belgium;(7)University Hospital Zurich- University of Zurich, Department of Gastroenterology and Hepatology, Zurich, Switzerland;
Background
Long-term treatment regimens for ulcerative colitis (UC) present challenges for patients who may need to interrupt therapy for various reasons.1 Filgotinib (FIL) is an oral Janus kinase 1 preferential inhibitor. We performed a post hoc analysis of data collected from patients with UC treated with FIL in the phase 2b/3 SELECTION programme to assess the efficacy and safety of re‑treatment following treatment interruption.
Methods
The SELECTION programme comprises two Induction Studies and a Maintenance Study (NCT02914522) and a long-term extension (LTE) study (NCT02914535). Adults aged 18–75 years with moderately to severely active UC, who had clinical remission or Mayo Clinic Score (MCS) response to FIL 200 mg or 100 mg at week 10 of SELECTION were re-randomized 2:1 to continue assigned FIL treatment or placebo (PBO) from week 11 to week 58. Patients with disease worsening (DW) in the Maintenance Study could enter the LTE study to receive open-label FIL 200 mg once daily. We assessed the efficacy of FIL in patients treated with induction FIL 200 mg or 100 mg who were randomized to PBO in the Maintenance Study and were re-treated with open-label FIL in the LTE study. Efficacy endpoints included partial MCS (pMCS) response and remission at LTE baseline and weeks 2, 4, 12 and 24. Non-responder imputation was used to analyse efficacy results.
Results
This analysis evaluated 50 patients treated with FIL 200 mg and 35 treated with FIL 100 mg in the Induction Study, who were withdrawn and re-treated upon DW. Baseline characteristics were similar among patients in the 200 mg and 100 mg treatment groups, with a median time to DW of 16.9 and 13.3 weeks, respectively. Mean pMCS declined rapidly in both groups from LTE baseline to week 2, reaching pMCS <2 at week 24 (Figure 1). By as early as week 2 of re-treatment, over 60% of patients in both groups had achieved pMCS response (Figure 2). By week 12, 78% of the 200 mg group and 94% of the 100 mg group achieved a pMCS response. Median time to response was 2.4 and 2.1 weeks in the 200 mg and 100 mg groups, respectively. Figure 3 shows that pMCS remission was achieved in 42% of the 200 mg group and 45% of the 100 mg group by week 24. Median time to pMCS remission was 23.6 and 12.1 weeks in the 200 mg and 100 mg groups, respectively. The number of adverse events upon re-treatment in the LTE was consistent with that reported in SELECTION (Table 1).
Conclusion
The majority of patients re-treated with FIL achieved pMCS response and remission within 12 weeks, with onset as early as week 2. Good disease control was maintained over the course of 24 weeks. Re-treatment was well tolerated, with no new safety signals observed among these patients.
1Rubin DT. Gastroenterol Hepatol 2019;15:612–5.