Tofacitinib with conventional synthetic disease‐modifying antirheumatic drugs in Chinese patients with rheumatoid arthritis: Patient‐reported outcomes from a Phase 3 randomized controlled trial |
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| Authors: | Zhanguo Li Yuan An Houheng Su Xiangpei Li Jianhua Xu Yi Zheng Guiye Li Kenneth Kwok Lisy Wang Qizhe Wu |
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| Affiliation: | 1. Peking University People's Hospital, Beijing, China;2. Qingdao Municipal Hospital, Qingdao, China;3. Anhui Provincial Hospital, Hefei, Anhui, China;4. First Affiliated Hospital of Anhui Medical University, Hefei, China;5. Beijing Chaoyang Hospital, Chaoyang District, Beijing, China;6. Pfizer Inc, Beijing, China;7. Pfizer Inc, New York, New York, USA;8. Pfizer Inc, Groton, Connecticut, USA |
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| Abstract: | Aim Tofacitinib is an oral Janus kinase inhibitor for the treatment of rheumatoid arthritis (RA). We assess the effect of tofacitinib + conventional synthetic disease‐modifying anti rheumatic drugs (csDMARDs) on patient‐reported outcomes in Chinese patients with RA and inadequate response to DMARDs. Methods This analysis of data from the Phase 3 study ORAL Sync included Chinese patients randomized 4 : 4 : 1 : 1 to receive tofacitinib 5 mg twice daily, tofacitinib 10 mg twice daily, placebo→tofacitinib 5 mg twice daily, or placebo→tofacitinib 10 mg twice daily, with csDMARDs. Placebo non‐responders switched to tofacitinib at 3 months; the remaining placebo patients switched at 6 months. Least squares mean changes from baseline were reported for Health Assessment Questionnaire‐Disability Index (HAQ‐DI), patient assessment of arthritis pain (Pain), patient global assessment of disease activity (PtGA), physician global assessment of disease activity (PGA), Functional Assessment of Chronic Illness Therapy‐Fatigue (FACIT‐F) scores, Short Form 36 (SF‐36), and Work Limitations Questionnaire (WLQ), using a mixed‐effects model for repeated measures. Results Overall, 216 patients were included (tofacitinib 5 mg twice daily, n = 86; tofacitinib 10 mg twice daily, n = 86; placebo→tofacitinib 5 mg twice daily, n = 22; placebo→tofacitinib 10 mg twice daily, n = 22). At month 3, tofacitinib elicited significant improvements in HAQ‐DI, Pain, PtGA, PGA and SF‐36 Physical Component Summary scores. Improvements were generally maintained through 12 months. Conclusion Tofacitinib 5 and 10 mg twice daily + csDMARDs resulted in improvements in health‐related quality of life, physical function and Pain through 12 months in Chinese patients with RA. |
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| Keywords: |
HAQ
pain patient‐reported outcomes rheumatoid arthritis tofacitinib |
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