Exposure‐response relationships for the efficacy and safety of filgotinib and its metabolite GS‐829845 in subjects with rheumatoid arthritis based on phase 2 and phase 3 studies

• Published in: British journal of clinical pharmacology Vol. 88; no. 7; pp. 3211 - 3221
• Main Authors: Meng, Amy, Anderson, Kacey, Nelson, Cara, Ni, Liyun, Chuang, Shu‐Min, Bellanti, Francesco, Chang, Peter, Comisar, Craig, Kearney, Brian P., Bartok, Beatrix, Mathias, Anita
• Format: Journal Article
• Language: English
• Published: England John Wiley and Sons Inc 01.07.2022
• Subjects: drug safety; Original; PK‐PD; randomized controlled trial; rheumatoid arthritis; Specialties: filgotinib, JAK inhibitors, exposure‐response; therapeutics; Specialties: filgotinib, JAK inhibitors, exposure-response; therapeutics; PK-PD; rheumatoid arthritis; drug safety; randomized controlled trial

Aims Filgotinib is a potent, oral, JAK1‐preferential inhibitor for the treatment of rheumatoid arthritis (RA). This report describes exposure‐response (ER) analyses of filgotinib for dose confirmation based on three phase 3 and two phase 2 studies in moderate to severe RA patients. Methods The pharm...