dc.contributor.author | Strand, V | |
dc.contributor.author | van der Heijde, D | |
dc.contributor.author | Tanaka, Y | |
dc.contributor.author | Keystone, E | |
dc.contributor.author | Kremer, J | |
dc.contributor.author | Zerbini, CAF | |
dc.contributor.author | Cardiel, MH | |
dc.contributor.author | Cohen, S | |
dc.contributor.author | Nash, P | |
dc.contributor.author | Song, YW | |
dc.contributor.author | Tegzová, D | |
dc.contributor.author | Gruben, D | |
dc.contributor.author | Wallenstein, G | |
dc.contributor.author | Connell, CA | |
dc.contributor.author | Fleischmann, R | |
dc.date.accessioned | 2021-01-12T05:15:19Z | |
dc.date.available | 2021-01-12T05:15:19Z | |
dc.date.issued | 2020 | |
dc.identifier.issn | 0392-856X | |
dc.identifier.uri | http://hdl.handle.net/10072/400931 | |
dc.description.abstract | Objective 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.peerreviewed | Yes | |
dc.language | English | |
dc.language.iso | eng | |
dc.publisher | Pacini Editore SpA | |
dc.publisher.uri | https://www.clinexprheumatol.org/abstract.asp?a=14326 | |
dc.relation.ispartofpagefrom | 848 | |
dc.relation.ispartofpageto | 857 | |
dc.relation.ispartofissue | 5 | |
dc.relation.ispartofjournal | Clinical and Experimental Rheumatology | |
dc.relation.ispartofvolume | 38 | |
dc.subject.fieldofresearch | Clinical sciences | |
dc.subject.fieldofresearchcode | 3202 | |
dc.title | Tofacitinib in combination with methotrexate in patients with rheumatoid arthritis: Patient-reported outcomes from the 24-month phase 3 ORAL scan study | |
dc.type | Journal article | |
dc.type.description | C1 - Articles | |
dcterms.bibliographicCitation | Strand, 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.dateAccepted | 2019-09-20 | |
dc.date.updated | 2021-01-12T05:13:39Z | |
gro.hasfulltext | No Full Text | |
gro.griffith.author | Nash, Peter | |