Tofacitinib with conventional synthetic disease‐modifying antirheumatic drugs in Chinese patients with rheumatoid arthritis: Patient‐reported outcomes from a Phase 3 randomized controlled trial

Abstract

AimTofacitinib 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.MethodsThis 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.ResultsOverall, 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.ConclusionTofacitinib 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.

Efficacy and Safety of Tofacitinib in Chinese Patients with Rheumatoid Arthritis

“…In line with the global Phase 3 studies[ 33 34 35 ] and as previously published,[ 31 ] significant improvements in patient-and physician-reported outcomes, including HAQ-DI, PtGA, PGA, and pain, were reported for tofacitinib-treated patients versus placebo-treated patients in the Chinese subpopulation of ORAL Sync.…”

“…By Month 12, all treatment groups showed similar changes in HAQ-DI scores, as previously reported. [ 31 ] Patients receiving tofacitinib 10 mg BID experienced numerically greater improvement versus tofacitinib 5 mg BID, at all time points.…”

“…Other outcomes, such as changes from baseline in PtGA, PGA, pain (VAS), and Short Form-36 scores in Chinese patients from ORAL Sync, have previously been reported. [ 31 ] Briefly, statistically significant improvements in PtGA were recorded with tofacitinib 5 and 10 mg BID versus placebo (both P < 0.05) at Month 3; the decreases continued through Month 12 for the tofacitinib 5 mg BID and placebo advanced to tofacitinib 5 mg BID groups, and Month 9 for the tofacitinib 10 mg BID and placebo advanced to tofacitinib 10 mg BID groups. Similarly, statistically significant improvements in PGA were recorded with both doses of tofacitinib at Month 3 and Month 6 ( P < 0.05).…”

“…Although the efficacy and safety of tofacitinib have been demonstrated in global Phase 3 studies and improved patient-reported outcomes of tofacitinib in Chinese patients with RA have been shown in a Phase 3 study,[ 31 ] the clinical effectiveness and tolerability of tofacitinib have not been previously reported exclusively in Chinese patients enrolled in Phase 3 and LTE studies. Given that different patient populations may present different clinical characteristics, different responses, and different risks, it is of interest to investigate clinical outcomes specific to Chinese patients.…”

Budget impact of introducing tofacitinib to the public hospital formulary in Hong Kong, 2017-2021

“…37,38 Patient preferences regarding RA treatment may affect compliance, adherence, and quality of life. 39,40 The route of administration significantly influences the decision between tofacitinib and biologics. 41 Among all factors that impact patients' therapeutic preferences, the convenience of oral administration has been shown to exhibit the strongest influence.…”