Effects of tofacitinib monotherapy on patient-reported outcomes in a randomized phase 3 study of patients with active rheumatoid arthritis and inadequate responses to DMARDs
RA presents a significant health and socioeconomic burden particularly in physical functioning, fatigue, and emotional roles. A phase III 6-month study of tofacitinib in patients with active RA, who had prior inadequate responses to cDMARDs or bDMARDs, uses patient-reported outcomes (PROs) to assess the impact on quality of life. Patients were randomized 4:4:1:1 to receive tofacitinib 5 or 10 mg BID, or placebo for 3 months followed by tofacitinib 5 or 10 mg BID.
At month 3, tofacitinib 5 and 10 mg demonstrated statistically significant improvements across multiple PROs including Patient Global Assessment of Disease Activity (PtGA). Pain, HAQ-DI, and Physical and Mental component summary scores. Significant changes versus placebo are seen at the first time point post-baseline, as early as 2 weeks. In patients continuing to month 6, improvements are greater for 10 versus 5 mg BID.
This study demonstrates that tofacitinib treatment provides relief from the burden of active RA, impacting a wide range of physical and emotional PROs.