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dc.contributor.authorStrand, V
dc.contributor.authorvan der Heijde, D
dc.contributor.authorTanaka, Y
dc.contributor.authorKeystone, E
dc.contributor.authorKremer, J
dc.contributor.authorZerbini, CAF
dc.contributor.authorCardiel, MH
dc.contributor.authorCohen, S
dc.contributor.authorNash, P
dc.contributor.authorSong, YW
dc.contributor.authorTegzová, D
dc.contributor.authorGruben, D
dc.contributor.authorWallenstein, G
dc.contributor.authorConnell, CA
dc.contributor.authorFleischmann, R
dc.date.accessioned2021-01-12T05:15:19Z
dc.date.available2021-01-12T05:15:19Z
dc.date.issued2020
dc.identifier.issn0392-856X
dc.identifier.urihttp://hdl.handle.net/10072/400931
dc.description.abstractObjective Tofacitinib is an oral Janus kinase inhibitor for the treatment of rheumatoid arthritis (RA). Here we present data from the completed Phase 3 randomised controlled trial (RCT) ORAL Scan (NCT00847613), which evaluated the impact of tofacitinib on patient-reported outcomes (PROs) through 24 months in patients with active RA and inadequate responses to methotrexate (MTX-IR). Methods Patients were randomised 4:4:1:1 to receive tofacitinib 5 or 10 mg twice daily (BID), or placebo advanced to tofacitinib 5 or 10 mg, plus background MTX. Patients receiving placebo advanced to tofacitinib at month 3 (non-responders) or month 6 (remaining patients). Mean changes from baseline in PROs, assessed at months 1-24, included Health Assessment Questionnaire-Disability Index, Patient Global Assessment of disease activity (visual analogue scale [VAS]), Patient Assessment of Arthritis Pain (VAS), health-related quality of life (Short Form-36 version 2), Functional Assessment of Chronic Illness Therapy-Fatigue and Medical Outcomes Study-Sleep. Results Overall, 539/797 (67.6%) patients completed 24 months’treatment. At month 3, tofacitinib-treated patients reported significant (p<0.05) mean changes from baseline versus placebo across all PROs, and significantly more patients reported improvements ≥ minimum clinically important differences versus placebo. Improvements in PROs with tofacitinib were sustained to month 24. Following advancement to tofacitinib, placebo-treated patients generally reported changes of similar magnitude to tofacitinib-treated patients. Conclusion Patients with RA and MTX-IR receiving tofacitinib 5 or 10 mg BID plus MTX reported significant and clinically meaningful improvements in PROs versus placebo at month 3, which were sustained through 24 months.
dc.description.peerreviewedYes
dc.languageEnglish
dc.language.isoeng
dc.publisherPacini Editore SpA
dc.publisher.urihttps://www.clinexprheumatol.org/abstract.asp?a=14326
dc.relation.ispartofpagefrom848
dc.relation.ispartofpageto857
dc.relation.ispartofissue5
dc.relation.ispartofjournalClinical and Experimental Rheumatology
dc.relation.ispartofvolume38
dc.subject.fieldofresearchClinical sciences
dc.subject.fieldofresearchcode3202
dc.titleTofacitinib in combination with methotrexate in patients with rheumatoid arthritis: Patient-reported outcomes from the 24-month phase 3 ORAL scan study
dc.typeJournal article
dc.type.descriptionC1 - Articles
dcterms.bibliographicCitationStrand, V; van der Heijde, D; Tanaka, Y; Keystone, E; Kremer, J; Zerbini, CAF; Cardiel, MH; Cohen, S; Nash, P; Song, YW; Tegzová, D; Gruben, D; Wallenstein, G; Connell, CA; Fleischmann, R, Tofacitinib in combination with methotrexate in patients with rheumatoid arthritis: Patient-reported outcomes from the 24-month phase 3 ORAL scan study, Clinical and Experimental Rheumatology, 2020, 38 (5), pp. 848-857
dcterms.dateAccepted2019-09-20
dc.date.updated2021-01-12T05:13:39Z
gro.hasfulltextNo Full Text
gro.griffith.authorNash, Peter


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