Aliment Pharmacol Ther. 2024 Sep;60(5):563-584. doi: 10.1111/apt.18158.Epub 2024 Jul 31.

Brian G Feagan ^1 2, Katsuyoshi Matsuoka ³, Gerhard Rogler ⁴, David Laharie ⁵, Séverine Vermeire ⁶, Silvio Danese ^7 8, Edward V Loftus Jr ⁹, Ian Beales ^10 11, Stefan Schreiber ¹², Hyo Jong Kim ¹³, Margaux Faes ¹⁴, Angela de Haas ¹⁵, Tomasz Masior ¹⁶, Christine Rudolph ¹⁵, Laurent Peyrin-Biroulet ^{17 18 19 20 21 22}

Author information

¹Alimentiv Inc., London, Ontario, Canada.

²Western University, London, Ontario, Canada.

³Division of Gastroenterology and Hepatology, Department of Internal Medicine, Toho University Sakura Medical Center, Chiba, Japan.

⁴Department of Gastroenterology and Hepatology, University Hospital Zurich, University of Zurich, Zurich, Switzerland.

⁵Gastroenterology Department, Hospital Center University de Bordeaux, Magellan Medico-Surgical Center, Haut-Lévêque Hospital, University of Bordeaux, INSERM, Bordeaux, France.

⁶Department of Gastroenterology and Hepatology, UZ Leuven, Leuven, Belgium.

⁷Department of Gastroenterology and Endoscopy, IRCCS Hospital San Raffaele, Milan, Italy.

⁸Vita-Salute San Raffaele University, Milan, Italy.

⁹Division of Gastroenterology and Hepatology, Mayo Clinic College of Medicine and Science, Rochester, Minnesota, USA.

¹⁰Department of Gastroenterology, Norfolk and Norwich University Hospitals NHS Foundation Trust, Norwich, UK.

¹¹University of East Anglia, Norwich, UK.

¹²Department Internal Medicine I, Kiel University, University Hospital Schleswig-Holstein, Kiel, Germany.

¹³Department of Gastroenterology, Center for Crohn's and Colitis, Kyung Hee University, South Korea.

¹⁴Galapagos NV, Mechelen, Belgium.

¹⁵Galapagos NV, Leiden, Netherlands.

¹⁶Galapagos GmbH, Basel, Switzerland.

¹⁷Department of Gastroenterology, Nancy University Hospital, Vandœuvre-lès-Nancy, France.

¹⁸INSERM, NGERE, University of Lorraine, Nancy, France.

¹⁹INFINY Institute, Nancy University Hospital, Vandœuvre-lès-Nancy, France.

²⁰FHU-CURE, Nancy University Hospital, Vandœuvre-lès-Nancy, France.

²¹Private Hospital Group Ambroise Paré - Hartmann, Paris IBD Center, Neuilly-sur-Seine, France.

²²Division of Gastroenterology and Hepatology, McGill University Health Centre, Montreal, Quebec, Canada.

Abstract

Background: Filgotinib, an oral, once-daily, Janus kinase 1 preferential inhibitor, is an approved treatment for moderately to severely active ulcerative colitis.

Aims: The aim of this study is to assess the safety and efficacy of continued filgotinib therapy over ~4 years in the long-term extension of the phase 2b/3 SELECTION trial (SELECTIONLTE; NCT02914535).

Methods: In this interim analysis of SELECTIONLTE, SELECTION completers (week 10 responders to filgotinib who completed the maintenance study) continued their assigned treatment (double-blind filgotinib 200 mg [FIL200] or filgotinib 100 mg) and SELECTION week 10 non-responders received open-label FIL200. We assessed safety by adverse events (AEs), and efficacy by partial Mayo Clinic Score (pMCS), inflammatory biomarkers and health-related quality of life (HRQoL). We compared safety and efficacy between achievers and non-achievers of a multi-component endpoint, comprehensive disease control (CDC), comprising symptomatic, endoscopic, inflammatory biomarker and HRQoL improvements.

Results: Data for completers (n = 250) and non-responders (n = 372) were reported for ≤202 weeks. AE occurrences were low and consistent with previous analyses. The as-observed proportion of FIL200-treated patients in pMCS, biomarker and HRQoL remission during SELECTIONLTE remained high among completers (week 144: 80.0%, 86.4% and 86.0%, respectively) and increased among non-responders (week 192: 62.1%, 76.7% and 59.3%, respectively). Significantly higher proportions of CDC achievers at SELECTION week 58 achieved pMCS, IBDQ and corticosteroid-free pMCS remission than non-achievers, up to LTE week 96.

Conclusions: Filgotinib induced and maintained symptomatic remission and improved HRQoL over 4 years. Safety results showed a proven long-term benefit-risk profile. FIL200-treated CDC achievers had better long-term outcomes than non-achievers.