Tofacitinib in combination with methotrexate in patients with rheumatoid arthritis: patient-reported outcomes from the 24-month Phase 3 ORAL Scan study

Strand, V.; Heijde, D. van der; Tanaka, Y.; Keystone, E.; Kremer, J.; Zerbini, C.A.F.; ... ; ORAL Scan Investigators (2020)

Article / Letter to editor

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<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.ConclusionPatients 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.

• methotrexate
• rheumatoid arthritis
• patient-reported outcome measures
• tofacitinib

• All authors: 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.; ORAL Scan Investigators
• Date: 2020-09-01
• Journal: Clinical and Experimental Rheumatology
• Volume: 38
• Issue: 5
• Pages: 848 - 857