Efficacy and safety of tofacitinib following inadequate response to conventional synthetic or biological disease-modifying antirheumatic drugs
This study evaluated the efficacy and safety of tofacitinib, an oral Janus kinase inhibitor, in patients with inadequate response to sDMARDs or bDMARDs. Findings from this study show both doses of tofacitinib were associated with improvements in efficacy parameters at month 3 versus placebo, and clinical response was numerically greater with bDMARD-naïve versus bDMARD-IR patients (95% CI overlapping). Safety parameters were generally similar; however, patients receiving glucocorticoids had more serious AEs, discontinuations due to AEs, serious infection events, and herpes zoster. Tofacitinib 10 mg BID had numerically greater clinical response and AEs compared to the 5mg BID dose.
Patients received tofacitinib 5 or 10 mg twice daily, or placebo, as monotherapy or with background methotrexate or other csDMARDs. Data on selected efficacy parameters – ACR 20/50/70 response, DAS28-4(ESR), HAQ-DI, CDAI, and CDAI – and adverse events were collected from 2812 bDMARD-naive and 705 bDMARD-IR patients.