Efficacy and Safety of Filgotinib for Patients with Rheumatoid Arthritis with Inadequate Response to Methotrexate: 52-Week Results
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Kivitz, Alan
Tanaka, Yoshiya
van der Heijde, Desiree
Simon-Campos, J-Abraham
Baraf, Herbert S
Kumar, Uma
Matzkies, Franziska
Bartok, Beatrix
Ye, Lei
Guo, Ying
Tasset, Chantal
Sundy, John S
Nash, Peter
et al.
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Background/Purpose: Filgotinib (FIL) is an oral, potent, selective Janus kinase 1 (JAK1) inhibitor. FINCH 1 (NCT02889796) assessed FIL efficacy and safety in patients (pts) with rheumatoid arthritis (RA) with an inadequate response to methotrexate (MTX-IR); primary outcome results at week (W)12 and W24 were previously reported.1 This analysis presents results from the FINCH 1 study through 52 weeks. Methods: This global, phase 3, double-blind, active- and placebo (PBO)-controlled study randomized MTX-IR pts with active RA on a background of sTable MTX 3:3:2:3 to oral FIL 200 mg or FIL 100 mg once daily, subcutaneous adalimumab (ADA) 40 mg every 2W, or PBO up to W52; pts receiving PBO at W24 were rerandomized to FIL 100 or 200 mg. Efficacy was assessed using clinical, radiographic, and pt-reported outcomes; W52 comparisons were not adjusted for multiplicity, and nominal p-values are reported. Safety endpoints included types and rates of adverse events (AEs) and laboratory abnormalities. Results: Of 1755 treated pts, 1417 received study drug through W52. The majority (81.8%) were female, mean (standard deviation [SD]) RA duration was 7.8 (7.6) years, and baseline mean (SD) DAS28(CRP) was 5.7 (0.9). FIL ef-ficacy was sustained through W52; 54%, 43%, and 46% of pts receiving FIL 200 and 100 mg and ADA, respectively, had W52 DAS28(CRP) < 2.6 (nominal p for FIL 200 vs ADA = 0.024) (Figure 1, Table 1). FIL safety profile through W52 was consistent with W24 data. AEs of interest were infrequent and balanced among treatments (Table 2). Conclusion: Through W52, both FIL 200 and 100 mg showed sustained efficacy based on clinical and pt-reported outcomes and radiographic progression and were well tolerated in MTX-IR pts with RA.
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Arthritis & Rheumatology
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72
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S10
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Clinical sciences
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Life Sciences & Biomedicine
Rheumatology
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Combe, B; Kivitz, A; Tanaka, Y; van der Heijde, D; Simon-Campos, J-A; Baraf, HS; Kumar, U; Matzkies, F; Bartok, B; Ye, L; Guo, Y; Tasset, C; Sundy, JS; Nash, P; et al., Efficacy and Safety of Filgotinib for Patients with Rheumatoid Arthritis with Inadequate Response to Methotrexate: 52-Week Results, Arthritis & Rheumatology, 2020, 72 (S10), pp. 399-402