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dc.contributor.authorCombe, Bernard
dc.contributor.authorKivitz, Alan
dc.contributor.authorTanaka, Yoshiya
dc.contributor.authorvan der Heijde, Désirée
dc.contributor.authorSimon, J Abraham
dc.contributor.authorBaraf, Herbert SB
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.authorJahreis, Angelika
dc.contributor.authorGenovese, Mark C
dc.contributor.authorMozaffarian, Neelufar
dc.contributor.authorLandewé, Robert BM
dc.contributor.authorBae, Sang-Cheol
dc.contributor.authorKeystone, Edward C
dc.contributor.authorNash, Peter
dc.date.accessioned2021-02-07T23:30:29Z
dc.date.available2021-02-07T23:30:29Z
dc.date.issued2021
dc.identifier.issn0003-4967
dc.identifier.doi10.1136/annrheumdis-2020-219214
dc.identifier.urihttp://hdl.handle.net/10072/401778
dc.description.abstractOBJECTIVE: To evaluate the efficacy and safety of the Janus kinase-1-preferential inhibitor filgotinib versus placebo or tumour necrosis factor-α inhibitor therapy in patients with active rheumatoid arthritis (RA) despite ongoing treatment with methotrexate (MTX). METHODS: This 52-week, multicentre, double-blind, placebo-controlled and active-controlled phase III trial evaluated once-daily oral filgotinib in patients with RA randomised 3:3:2:3 to filgotinib 200 mg (FIL200) or filgotinib 100 mg (FIL100), subcutaneous adalimumab 40 mg biweekly, or placebo (through week 24), all with stable weekly background MTX. The primary endpoint was the proportion of patients achieving 20% improvement in American College of Rheumatology criteria (ACR20) at week 12. Additional efficacy outcomes were assessed sequentially. Safety was assessed from adverse events and laboratory abnormalities. RESULTS: The proportion of patients (n=1755 randomised and treated) achieving ACR20 at week 12 was significantly higher for FIL200 (76.6%) and FIL100 (69.8%) versus placebo (49.9%; treatment difference (95% CI), 26.7% (20.6% to 32.8%) and 19.9% (13.6% to 26.2%), respectively; both p<0.001). Filgotinib was superior to placebo in key secondary endpoints assessing RA signs and symptoms, physical function and structural damage. FIL200 was non-inferior to adalimumab in terms of Disease Activity Score in 28 joints with C reactive protein ≤3.2 at week 12 (p<0.001); FIL100 did not achieve non-inferiority. Adverse events and laboratory abnormalities were comparable among active treatment arms. CONCLUSIONS: Filgotinib improved RA signs and symptoms, improved physical function, inhibited radiographic progression and was well tolerated in patients with RA with inadequate response to MTX. FIL200 was non-inferior to adalimumab. TRIAL REGISTRATION NUMBER: NCT02889796.
dc.description.peerreviewedYes
dc.languageeng
dc.publisherBMJ
dc.relation.ispartofjournalAnnals of the Rheumatic Diseases
dc.subject.fieldofresearchClinical sciences
dc.subject.fieldofresearchImmunology
dc.subject.fieldofresearchHealth services and systems
dc.subject.fieldofresearchPublic health
dc.subject.fieldofresearchcode3202
dc.subject.fieldofresearchcode3204
dc.subject.fieldofresearchcode4203
dc.subject.fieldofresearchcode4206
dc.subject.keywordsantirheumatic agents
dc.subject.keywordsarthritis
dc.subject.keywordsrheumatoid
dc.subject.keywordstherapeutics
dc.titleFilgotinib versus placebo or adalimumab in patients with rheumatoid arthritis and inadequate response to methotrexate: a phase III randomised clinical trial
dc.typeJournal article
dc.type.descriptionC1 - Articles
dcterms.bibliographicCitationCombe, B; Kivitz, A; Tanaka, Y; van der Heijde, D; Simon, JA; Baraf, HSB; Kumar, U; Matzkies, F; Bartok, B; Ye, L; Guo, Y; Tasset, C; Sundy, JS; Jahreis, A; Genovese, MC; Mozaffarian, N; Landewé, RBM; Bae, S-C; Keystone, EC; Nash, P, Filgotinib versus placebo or adalimumab in patients with rheumatoid arthritis and inadequate response to methotrexate: a phase III randomised clinical trial, Annals of the Rheumatic Diseases, 2021
dcterms.dateAccepted2021-01-06
dcterms.licensehttp://creativecommons.org/licenses/by-nc/4.0/
dc.date.updated2021-02-07T23:19:45Z
dc.description.versionVersion of Record (VoR)
gro.description.notepublicThis publication has been entered as an advanced online version in Griffith Research Online.
gro.rights.copyright© Author(s) (or their employer(s)) 2021. This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.
gro.hasfulltextFull Text
gro.griffith.authorNash, Peter


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