Aliment Pharmacol Ther. 2023 Nov;58(9):874-887. doi: 10.1111/apt.17674.Epub 2023 Sep 18.

Stefan Schreiber ¹, Gerhard Rogler ², Mamoru Watanabe ³, Séverine Vermeire ⁴, Christian Maaser ⁵, Silvio Danese ^6 7, Margaux Faes ⁸, Paul Van Hoek ⁸, Jeremy Hsieh ⁹, Ulrik Moerch ¹⁰, Yan Zhou ⁹, Angela de Haas ¹¹, Christine Rudolph ¹¹, Alessandra Oortwijn ¹¹, Edward V Loftus Jr ¹²

Author information

¹Department Medicine I, University Hospital Schleswig-Holstein, Kiel, Germany.

²University Hospital of Zurich, University of Zurich, Zurich, Switzerland.

³Advanced Research Institute, Tokyo Medical and Dental University, Tokyo, Japan.

⁴Department of Gastroenterology and Hepatology, University Hospitals Leuven, Leuven, Belgium.

⁵Outpatients Department of Gastroenterology, Department of Geriatrics, Hospital Lüneburg, Lüneburg, Germany.

⁶Gastroenterology and Endoscopy, IRCCS Ospedale San Raffaele, Milan, Italy.

⁷Vita-Salute San Raffaele University, Milan, Italy.

⁸Galapagos NV, Mechelen, Belgium.

⁹Gilead Sciences, Inc., Foster City, California, USA.

¹⁰Gilead Sciences, Inc., Copenhagen, Denmark.

¹¹Galapagos NV, Leiden, the Netherlands.

¹²Division of Gastroenterology and Hepatology, Mayo Clinic College of Medicine and Science, Rochester, Minnesota, USA.

Abstract

Background: Filgotinib 200 mg (FIL200) is an approved treatment for adults with moderately to severely active ulcerative colitis (UC).

Aim: To report integrated safety data from the phase 2b/3 SELECTION study (NCT02914522) and its ongoing long-term extension study SELECTIONLTE (NCT02914535).

Methods: Safety outcomes were analysed in adults with moderately to severely active UC who received FIL200, filgotinib 100 mg (FIL100) or placebo once daily throughout the 11-week SELECTION induction study, the 47-week SELECTION maintenance study (if applicable) and SELECTIONLTE (if applicable). Exposure-adjusted incidence rates (EAIRs) per 100 censored patient-years of exposure with 95% confidence intervals were reported for treatment-emergent adverse events (AEs). Certain AE data were presented in subgroups, including age and prior biologic exposure status.

Results: This interim analysis included 1348 patients representing 3326.2 patient-years of exposure. Baseline characteristics of patients entering SELECTION were similar across treatment groups. EAIRs for serious infection, thromboembolic events and major adverse cardiovascular events (MACE) were consistently low across treatment groups. Most patients with MACE had cardiovascular risk factors. The EAIR for herpes zoster was numerically higher for FIL200 than for placebo. Infection incidences were numerically higher in biologic-experienced than biologic-naive patients. Higher incidences of certain AEs in patients 65 years of age or older were as expected. Four deaths occurred, including three cardiovascular deaths, none of which was considered related to filgotinib.

Conclusion: FIL200 and FIL100 were well tolerated with no unexpected safety signals in patients with moderately to severely active UC, regardless of previous biologic exposure or age.

Gov identifiers (nct numbers): NCT02914522, NCT02914535.