Unknown

Dataset Information

0

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: 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.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.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.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.

SUBMITTER: Li Z 

PROVIDER: S-EPMC5817244 | BioStudies | 2018-01-01

SECONDARY ACCESSION(S): NCT00856544

REPOSITORIES: biostudies

Similar Datasets

2017-01-01 | S-EPMC5413813 | BioStudies
2019-01-01 | S-EPMC6340575 | BioStudies
2019-01-01 | S-EPMC6340607 | BioStudies
2020-01-01 | S-EPMC7566034 | BioStudies
2019-01-01 | S-EPMC6902348 | BioStudies
2017-01-01 | S-EPMC5353328 | BioStudies
2015-01-01 | S-EPMC4632359 | BioStudies
1000-01-01 | S-EPMC4941182 | BioStudies
2017-01-01 | S-EPMC5372156 | BioStudies
2016-01-01 | S-EPMC5108430 | BioStudies