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Evaluate tofacitinib efficacy, safety and persistence by sex in rheumatoid arthritis (RA).
Post hoc analyses using data from phase III placebo-controlled randomised controlled trials (ORAL Scan, ORAL Sync and ORAL Standard).
ORAL Scan, ORAL Sync and ORAL Standard were global, multicentre trials conducted across 111, 114 and 115 sites, respectively.
The trials enrolled adults with active RA and prior inadequate response to methotrexate (ORAL Scan/ORAL Standard) or ≥1 conventional synthetic or biologic disease-modifying antirheumatic drug (ORAL Sync). Post hoc analyses included 2265 patients (1870 female and 395 male).
Patients received tofacitinib 5 mg or 10 mg two times a day, adalimumab or placebo.
Efficacy outcomes to month 12 included American College of Rheumatology (ACR)20, 50 and 70 responses, Disease Activity Score in 28 joints (DAS28) (erythrocyte sedimentation rate (ESR))-defined low disease activity (LDA) and remission, DAS28 (C reactive protein (CRP)) ≤3.2 and
At baseline, female patients had similar DAS28(CRP and ESR), slightly higher HAQ-DI and lower FACIT-F scores versus male patients (n=395). ORs for active treatments (tofacitinib and adalimumab) versus placebo were generally >1 for ACR20, 50 and 70 responses, DAS28(CRP) ≤3.2 and
In post hoc analyses, tofacitinib was efficacious across both sexes, with higher responses in males observed particularly for more stringent composite endpoints and patient-reported outcomes. Findings are generally consistent with studies of other advanced RA therapies. Safety and persistence were similar across sexes. Interpretation is limited by the small proportion of male patients (
NCT00847613,
FreshRSS 