dc.contributor.author | Combe, Bernard | |
dc.contributor.author | Kivitz, Alan | |
dc.contributor.author | Tanaka, Yoshiya | |
dc.contributor.author | van der Heijde, Désirée | |
dc.contributor.author | Simon, J Abraham | |
dc.contributor.author | Baraf, Herbert SB | |
dc.contributor.author | Kumar, Uma | |
dc.contributor.author | Matzkies, Franziska | |
dc.contributor.author | Bartok, Beatrix | |
dc.contributor.author | Ye, Lei | |
dc.contributor.author | Guo, Ying | |
dc.contributor.author | Tasset, Chantal | |
dc.contributor.author | Sundy, John S | |
dc.contributor.author | Jahreis, Angelika | |
dc.contributor.author | Genovese, Mark C | |
dc.contributor.author | Mozaffarian, Neelufar | |
dc.contributor.author | Landewé, Robert BM | |
dc.contributor.author | Bae, Sang-Cheol | |
dc.contributor.author | Keystone, Edward C | |
dc.contributor.author | Nash, Peter | |
dc.date.accessioned | 2021-02-07T23:30:29Z | |
dc.date.available | 2021-02-07T23:30:29Z | |
dc.date.issued | 2021 | |
dc.identifier.issn | 0003-4967 | |
dc.identifier.doi | 10.1136/annrheumdis-2020-219214 | |
dc.identifier.uri | http://hdl.handle.net/10072/401778 | |
dc.description.abstract | OBJECTIVE: 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.peerreviewed | Yes | |
dc.language | eng | |
dc.publisher | BMJ | |
dc.relation.ispartofjournal | Annals of the Rheumatic Diseases | |
dc.subject.fieldofresearch | Clinical sciences | |
dc.subject.fieldofresearch | Immunology | |
dc.subject.fieldofresearch | Health services and systems | |
dc.subject.fieldofresearch | Public health | |
dc.subject.fieldofresearchcode | 3202 | |
dc.subject.fieldofresearchcode | 3204 | |
dc.subject.fieldofresearchcode | 4203 | |
dc.subject.fieldofresearchcode | 4206 | |
dc.subject.keywords | antirheumatic agents | |
dc.subject.keywords | arthritis | |
dc.subject.keywords | rheumatoid | |
dc.subject.keywords | therapeutics | |
dc.title | Filgotinib versus placebo or adalimumab in patients with rheumatoid arthritis and inadequate response to methotrexate: a phase III randomised clinical trial | |
dc.type | Journal article | |
dc.type.description | C1 - Articles | |
dcterms.bibliographicCitation | Combe, 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.dateAccepted | 2021-01-06 | |
dcterms.license | http://creativecommons.org/licenses/by-nc/4.0/ | |
dc.date.updated | 2021-02-07T23:19:45Z | |
dc.description.version | Version of Record (VoR) | |
gro.description.notepublic | This 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.hasfulltext | Full Text | |
gro.griffith.author | Nash, Peter | |