Tofacitinib with Conventional Synthetic Disease-modifying Antirheumatic Drugs in Chinese Patients with Rheumatoid Arthritis: Patient-reported Outcomes from a Phase 3 Randomised Controlled Trial

Int J Rheum Dis 2018; 21(2):402–14

This Chinese sub-population of patients with RA from ORAL Sync reported significant improvements in patient-reported outcomes (PROs), which were maintained up to 12 months from tofacitinib (TOF) treatment initiation. ORAL Sync was a randomised, Phase 3 study investigating TOF therapy in combination with csDMARDs in patients with active RA who had previously had an inadequate response to csDMARDs. To date, this is the only Phase 3 study of TOF in patients from China with RA. This analysis included 216 Chinese patients from ORAL Sync, who were randomised to receive TOF 5 mg BID, TOF 10 mg BID, placebo switch to TOF 5 mg BID or placebo switch to TOF 10 mg BID. PROs investigated included: HAQ-DI, patient global assessment (PtGA), physician global assessment (PGA), Pain and SF-36 mental and physical component scores.At 3 months, patients receiving TOF 5 or 10 mg BID reported significant reductions in Pain and improvements in HAQ-DI, PtGA, PGA and SF-36 physical component score versus placebo. At 6 months, patients receiving TOF continued to report significant reductions in Pain, and improvements in HAQ-DI and PGA compared with placebo. Additionally, at 6 months, patients who received TOF 10 mg BID had significant improvements in SF-36 mental component score and FACIT-F.Overall, Chinese patients given TOF reported significant improvements in several PROs, consistent with the global population of ORAL Sync, reflecting improvements in health-related quality of life, physical function and Pain up to 12 months.