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dc.contributor.authorCombe, Bernard
dc.contributor.authorKivitz, Alan
dc.contributor.authorTanaka, Yoshiya
dc.contributor.authorvan der Heijde, Desiree
dc.contributor.authorSimon-Campos, J-Abraham
dc.contributor.authorBaraf, Herbert S
dc.contributor.authorKumar, Uma
dc.contributor.authorMatzkies, Franziska
dc.contributor.authorBartok, Beatrix
dc.contributor.authorYe, Lei
dc.contributor.authorGuo, Ying
dc.contributor.authorTasset, Chantal
dc.contributor.authorSundy, John S
dc.contributor.authorNash, Peter
dc.contributor.authoret al.
dc.date.accessioned2021-04-09T06:11:05Z
dc.date.available2021-04-09T06:11:05Z
dc.date.issued2020
dc.identifier.issn2326-5191en_US
dc.identifier.urihttp://hdl.handle.net/10072/403650
dc.description.abstractBackground/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.en_US
dc.languageEnglishen_US
dc.publisherWileyen_US
dc.publisher.urihttps://onlinelibrary.wiley.com/doi/10.1002/art.41538en_US
dc.relation.ispartofconferencenameACR Convergence 2020en_US
dc.relation.ispartofconferencetitleArthritis & Rheumatologyen_US
dc.relation.ispartofdatefrom2020-11-05
dc.relation.ispartofdateto2020-11-09
dc.relation.ispartoflocationVirtualen_US
dc.relation.ispartofpagefrom399en_US
dc.relation.ispartofpageto402en_US
dc.relation.ispartofissueS10en_US
dc.relation.ispartofvolume72en_US
dc.subject.fieldofresearchClinical Sciencesen_US
dc.subject.fieldofresearchcode1103en_US
dc.subject.keywordsScience & Technologyen_US
dc.subject.keywordsLife Sciences & Biomedicineen_US
dc.subject.keywordsRheumatologyen_US
dc.titleEfficacy and Safety of Filgotinib for Patients with Rheumatoid Arthritis with Inadequate Response to Methotrexate: 52-Week Resultsen_US
dc.typeConference outputen_US
dc.type.descriptionE3 - Conferences (Extract Paper)en_US
dcterms.bibliographicCitationCombe, 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. 399-402en_US
dc.date.updated2021-04-09T05:52:03Z
gro.hasfulltextNo Full Text
gro.griffith.authorNash, Peter


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