Tofacitinib in Combination with Methotrexate in Patients with Rheumatoid Arthritis: Patient-reported Outcomes from the 24-month Phase 3 ORAL Scan study

Clin Exp Rheumatol . Sep-Oct 2020;38(5):848-857. Epub 2019 Dec 19.

In the ORAL SCAN study, patients receiving TOF 5 mg or 10 mg BID reported significant improvements in patient-reported outcomes at month 3 compared with placebo, which were maintained through 24 months of treatment.RA causes a significant health and socioeconomic burden and affects all aspects of health related quality of life. ORAL Scan included patients with active RA and inadequate response to MTX who were randomised to receive TOF 5 mg or 10 mg BID plus MTX or PBO. This study evaluated the impact of TOF on PROs including; patient global assessment of disease activity (VAS), HAQ-DI, patient assessment of pain (VAS), health-related quality of life (SF-36), fatigue, and sleep.At month 3, TOF-treated patients reported significant improvements from baseline versus placebo across all PROs, and significantly more patients reported improvements greater than the minimum clinically important differences versus placebo. Improvements in PROs with TOF were sustained through 24 months. Following advancement to TOF at month 3 or 6, placebo-treated patients generally reported changes of similar magnitude to TOF-treated patients. Limitations included low exposure to placebo at early time points and termination of the control arm preventing direct comparison beyond month 3.