Abstract:
Rheumatoid arthritis (RA) is a chronic systemic autoimmune disease characterized by synovial inflammation, progressive joint
destruction, and disability. Despite biologic DMARDs, many patients remain uncontrolled. Tofacitinib, an oral Janus kinase (JAK) inhibitor, offers an
alternative mechanism with convenient oral dosing. Objectives: To assess the long-term efficacy and safety of tofacitinib in patients with RA inade quately controlled by conventional synthetic DMARDs (csDMARDs). Methods: Sixty-five RA patients fulfilling 2010 ACR/EULAR criteria and DAS28-
CRP ≥3.2 were enrolled in a single-center, 104-week, prospective cohort. Patients received tofacitinib 5 mg twice daily with background csDMARDs.
Primary endpoints were ACR20/50/70 responses. Secondary endpoints included DAS28-CRP, CDAI, HAQ-DI, and patient-reported outcomes. Safety
was monitored with exposure-adjusted incidence rates. Results: At 104 weeks, 78% achieved ACR20, 60% ACR50, and 32% ACR70. Mean DAS28-CRP
decreased from 5.6 ± 0.9 at baseline to 2.6 ± 0.6 (p<0.001). Clinically meaningful improvement (ΔDAS28 ≥1.2) was observed in 86% of patients, and
48% achieved DAS28 remission (<2.6). CDAI improved from 32 ± 8.4 to 8 ± 3.2, with 42% achieving CDAI remission (<2.8). HAQ-DI decreased from
1.4 ± 0.5 to 0.6 ± 0.2 (p<0.001). Safety was consistent with prior reports: any treatment-emergent AE occurred at 90/100 patient-years, serious AEs
at 14/100, infections at 38/100, herpes zoster at 6/100, venous thromboembolism at 2.5/100, and major adverse cardiovascular events at 2/100
patient-years. Conclusion: Over 104 weeks, tofacitinib produced sustained improvements in disease activity, function, and remission rates, with a
manageable safety profile. These findings support tofacitinib as a durable oral option for RA patients with inadequate csDMARD response.
