Background Rheumatoid arthritis (RA) worsens patients' health-related quality of life.1 Tofacitinib is an oral Janus kinase (JAK) inhibitor for the treatment of RA. Improvements in patient-reported outcomes (PROs) have been reported in the global population of Phase 3 tofacitinib trials.2
Objectives To explore the effect of tofacitinib administered with conventional synthetic DMARDs (csDMARDs) on PROs in Chinese patients with RA and an inadequate response to DMARDs.
Methods This was a post-hoc analysis of data from Chinese patients in the 12 month, double-blind Phase 3 study ORAL Sync (NCT00856544), with patients randomised 4:4:1:1 to tofacitinib 5 mg BID, tofacitinib 10 mg BID, placebo (PBO)→tofacitinib 5 mg BID or PBO→tofacitinib 10 mg BID, with csDMARDs. Non-responders (defined as those who did not achieve a 20% improvement in both of the swollen or tender joint counts) receiving PBO advanced blindly to tofacitinib at Month 3; all remaining PBO patients advanced to tofacitinib at Month 6. Least squares mean changes from baseline were reported for Health Assessment Questionnaire-Disability Index (HAQ-DI), patient assessment of arthritis pain (VAS), patient global assessment of disease activity (PtGA), Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue scale, Short Form-36 Health Survey (SF-36), EuroQol five dimensions questionnaire (EQ-5D), and Work Limitations Questionnaire (WLQ), using a mixed-effects model for repeated measures. All patients receiving ≥1 dose of study treatment with ≥1 post-baseline assessment were included.
Results Overall 216 patients were included (n=86, tofacitinib 5 mg BID; n=86, tofacitinib 10 mg BID; n=22, PBO→tofacitinib 5 mg BID; n=22, PBO→tofacitinib 10 mg BID). There were no major differences in demographics or baseline characteristics between treatment groups. At Month 3, tofacitinib resulted in significantly greater changes in HAQ-DI (5 mg BID, p<0.05; 10 mg BID, p<0.001), PtGA (5 mg BID, p<0.05; 10 mg BID, p<0.001), Pain (5 mg BID, p<0.001; 10 mg BID, p<0.001) and SF-36 Physical Component Summary (PCS) scores (5 mg BID, p<0.05; 10 mg BID, p<0.001) vs PBO (Figure). Numeric improvements in FACIT-Fatigue, SF-36 Mental Component Summary (MCS) [Figure] and EQ-5D health state profile (utility scores) were observed at Month 3 with tofacitinib vs PBO. There were no improvements in WLQ observed at Month 3 with tofacitinib vs PBO. Improvements were generally maintained at 6 and 12 months (Figure). The proportion of patients achieving HAQ-DI improvement ≥0.22 from baseline at Month 3 was significantly higher with tofacitinib vs PBO (5 mg BID, p<0.05; 10 mg BID, p<0.05).
Conclusions Tofacitinib 5 and 10 mg BID administered with csDMARDs significantly improved PROs including SF-36 PCS, PtGA, physical function and pain vs PBO. These improvements were maintained for up to 12 months in Chinese patients with RA.
Strand V, Khanna D. Clin Exp Rheumatol 2010; 28: S32-S40.
Strand V et al. Arthritis Care Res (Hoboken) 2016. doi:10.1002/acr.23004.
Acknowledgements This study was sponsored by Pfizer Inc. Editorial support was provided by C Evans of CMC and was funded by Pfizer Inc.
Disclosure of Interest Z. Li Grant/research support from: Pfizer Inc, Consultant for: Pfizer Inc, Y. An Grant/research support from: Pfizer Inc, Consultant for: Pfizer Inc, G. Li Shareholder of: Pfizer Inc, Employee of: Pfizer Inc, L. Wang Shareholder of: Pfizer Inc, Employee of: Pfizer Inc, K. Kwok Shareholder of: Pfizer Inc, Employee of: Pfizer Inc, Q. Wu Shareholder of: Pfizer Inc, Employee of: Pfizer Inc