Publication: Integrated safety analysis of filgotinib for ulcerative colitis: Results from SELECTION and SELECTIONLTE
Integrated safety analysis of filgotinib for ulcerative colitis: Results from SELECTION and SELECTIONLTE
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Schreiber, S., Rogler, G., Watanabe, M., Vermeire, S., Maaser, C., Danese, S., Faes, M., Van Hoek, P., Hsieh, J., Moerch, U., Zhou, Y., de Haas, A., Rudolph, C., Oortwijn, A., & Loftus, E. V. (2023). Integrated safety analysis of filgotinib for ulcerative colitis: Results from SELECTION and SELECTIONLTE. Alimentary Pharmacology & Therapeutics, 58(9), 874–887. https://doi.org/10.1111/apt.17674
Abstract
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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 stud
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Schreiber, S., Rogler, G., Watanabe, M., Vermeire, S., Maaser, C., Danese, S., Faes, M., Van Hoek, P., Hsieh, J., Moerch, U., Zhou, Y., de Haas, A., Rudolph, C., Oortwijn, A., & Loftus, E. V. (2023). Integrated safety analysis of filgotinib for ulcerative colitis: Results from SELECTION and SELECTIONLTE. Alimentary Pharmacology & Therapeutics, 58(9), 874–887. https://doi.org/10.1111/apt.17674