THU0200 Effect of Methotrexate Dose on The Efficacy of Tofacitinib: Treatment Outcomes from A Phase 3 Clinical Trial of Patients with Rheumatoid Arthritis

BackgroundTofacitinib is an oral JAK inhibitor for the treatment of rheumatoid arthritis (RA). ORAL Scan was a 2-year, randomised, Phase 3, clinical trial that evaluated tofacitinib therapy with background methotrexate (MTX) in patients (pts) with RA and an inadequate response (IR) to MTX.1Objective...

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Veröffentlicht in:Annals of the rheumatic diseases 2016-06, Vol.75 (Suppl 2), p.258-259
Hauptverfasser: Fleischmann, R., Mease, P., Schwartzman, S., Hwang, L.-J., Soma, K., Connell, C., Takiya, L., Bananis, E.
Format: Artikel
Sprache:eng
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Zusammenfassung:BackgroundTofacitinib is an oral JAK inhibitor for the treatment of rheumatoid arthritis (RA). ORAL Scan was a 2-year, randomised, Phase 3, clinical trial that evaluated tofacitinib therapy with background methotrexate (MTX) in patients (pts) with RA and an inadequate response (IR) to MTX.1ObjectivesTo study the effect of MTX dose on tofacitinib efficacy in pts from the ORAL Scan study.MethodsIn ORAL Scan, MTX-IR pts with RA were randomised 4:4:1:1 to tofacitinib 5 mg twice daily (BID), tofacitinib 10 mg BID, or placebo with advancement to 5 mg BID or to 10 mg BID at Month (Mo) 3 or Mo 6, in combination with background MTX. MTX dose was stable throughout the study and was categorised as Low (≤12.5 mg/week), Medium (>12.5 to
ISSN:0003-4967
1468-2060
DOI:10.1136/annrheumdis-2016-eular.1274