1. Tofacitinib in combination with methotrexate in patients with rheumatoid arthritis: patient-reported outcomes from the 24-month Phase 3 ORAL Scan study
- Author
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Strand, V., Heijde, D. van der, Tanaka, Y., Keystone, E., Kremer, J., Zerbini, C.A.F., Cardiel, M.H., Cohen, S., Nash, P., Song, Y.W., Tegzova, D., Gruben, D., Wallenstein, G., Connell, C.A., Fleischmann, R., and ORAL Scan Investigators
- Subjects
rheumatoid arthritis ,tofacitinib ,methotrexate ,patient-reported outcome measures - Abstract
ObjectiveTofacitinib 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).MethodsPatients 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.ResultsOverall, 539/797 ( 67.6%) patients completed 24 months' treatment. At month 3, tofacitinib-treated patients reported significant (p
- Published
- 2020