title: Tofacitinib versus methotrexate in rheumatoid arthritis: patient-reported outcomes from the randomised phase III ORAL Start trial.
abstract: OBJECTIVE
  To compare patient-reported outcomes (PROs) in methotrexate (MTX)-naive patients (defined as no prior treatment or ≤3 doses) receiving tofacitinib versus MTX.
  
  
  METHODS
  In the 24-month, phase III, randomised, controlled, ORAL Start trial (NCT01039688), patients were randomised 2:2:1 to receive tofacitinib 5 mg two times per day (n=373), tofacitinib 10 mg two times per day (n=397) or MTX (n=186). PROs assessed included Patient Global Assessment of disease (PtGA), pain, Health Assessment Questionnaire-Disability Index (HAQ-DI), Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) and health-related quality of life (Short Form-36 [SF-36]).
  
  
  RESULTS
  PROs improved following tofacitinib and MTX treatment: benefits were sustained over 24 months. Patients receiving tofacitinib reported earlier responses which were significantly different between each tofacitinib dose and MTX at month 3 through month 24. At month 6 (primary end point), significant improvements versus MTX were observed in PtGA, pain, HAQ-DI, SF-36 Physical Component Summary (PCS), 5/8 domain scores and FACIT-F with tofacitinib 5 mg two times per day; all PROs, except SF-36 Mental Component Summary Score and Medical Outcomes Survey-Sleep, with tofacitinib 10 mg two times per day. At month 6, the proportion of patients reporting improvements ≥minimum clinically important difference were significant versus MTX with tofacitinib 5 mg two times per day in PtGA and 3/8 SF-36 domains; and with tofacitinib 10 mg two times per day in PtGA, pain, HAQ-DI, SF-36 PCS, 4/8 domains and FACIT-F.
  
  
  CONCLUSIONS
  Patients with rheumatoid arthritis receiving tofacitinib 5 and 10 mg two times per day monotherapy versus MTX reported statistically significant and clinically meaningful improvements in multiple PROs over 24 months; onset of benefit with tofacitinib treatment occurred earlier.
  
  
  BACKGROUND
  NCT01039688.
authors.affiliation: Division of Immunology/Rheumatology , Stanford University School of Medicine , Palo Alto, California , USA.
authors.forename: Vibeke
authors.initials: V
authors.lastname: Strand
authors.affiliation: Department of Internal Medicine , Seoul National University College of Medicine , Seoul , South Korea.
authors.forename: Eun Bong
authors.initials: EB
authors.lastname: Lee
authors.affiliation: Department of Medicine , University of Texas Southwestern Medical Center, Metroplex Clinical Research Center , Dallas, Texas , USA.
authors.forename: Roy
authors.initials: R
authors.lastname: Fleischmann
authors.affiliation: Department of Internal Medicine , Rheumatology, Schlosspark-Klinik, University Medicine Berlin , Berlin , Germany.
authors.forename: Rieke E
authors.identifier: 0000-0002-3395-4412
authors.initials: RE
authors.lastname: Alten
authors.affiliation: Global Innovative Pharmaceuticals , Pfizer , New York, New York , USA.
authors.forename: Tamas
authors.initials: T
authors.lastname: Koncz
authors.affiliation: Global Innovative Pharmaceuticals , Pfizer , Groton, Connecticut , USA.
authors.forename: Samuel H
authors.initials: SH
authors.lastname: Zwillich
authors.affiliation: Global Innovative Pharmaceuticals , Pfizer , Groton, Connecticut , USA.
authors.forename: David
authors.initials: D
authors.lastname: Gruben
authors.affiliation: Global Innovative Pharmaceuticals , Pfizer , Groton, Connecticut , USA.
authors.forename: Bethanie
authors.initials: B
authors.lastname: Wilkinson
authors.affiliation: Global Innovative Pharmaceuticals , Pfizer , Groton, Connecticut , USA.
authors.forename: Sriram
authors.initials: S
authors.lastname: Krishnaswami
authors.affiliation: Global Innovative Pharmaceuticals , Pfizer , Groton, Connecticut , USA.
authors.forename: Gene
authors.initials: G
authors.lastname: Wallenstein
keywords: Methotrexate; Patient perspective; Rheumatoid Arthritis