Tofacitinib in Combination with Conventional DMARDs in Patients with Active Rheumatoid Arthritis: PROs from a Phase 3 Randomised Controlled Trial
Further evidence is presented that treatment with tofacitinib improves patient-reported outcomes (PROs), in addition to improving underlying disease activity.
Data were analysed from the Phase 3 ORAL Sync 12-month randomised controlled trial in adult patients with active RA and previous inadequate response to ≥1 conventional or biologic DMARD(s). Patients received (4:4:1:1) TOF 5mg or 10mg BID or Placebo advanced to 5 mg or
10 mg BID plus conventional DMARD(s).
PROs assessed at Month 3 were: Patient Global Assessment of Arthritis (PtGA), Pain, HAQ-DI, HRQoL (by assessing the individual Short-Form [SF]-36 domains: physical function, role-physical, general health, vitality, social functioning, role-emotional, and mental health), fatigue, and sleep.
At Month 3, statistically significant and clinically meaningful improvements in all PROs versus placebo were observed with TOF 10 mg, and were sustained through Month 12. For TOF 5mg BID, all PROs except the role-emotional domain showed significant improvement.