CLINICAL PROFILE AND RESPONSE TO TOFACITINIB IN PATIENTS WITH RHEUMATOID ARTHRITIS REFRACTORY TO COMBINATION SYNTHETIC DMARDS

Abstract

Rheumatoid arthritis (RA) is a chronic systemic autoimmune inflammatory disease characterized by persistent synovitis, progressive joint destruction, and extra-articular manifestations. Despite optimal use of conventional synthetic disease-modifying antirheumatic drugs (csDMARDs), a subset of patients continues to have active disease. Tofacitinib, an oral Janus kinase (JAK) inhibitor, offers a targeted therapeutic option for such refractory cases.

Objectives: To evaluate the clinical profile and assess the efficacy and safety of tofacitinib in patients with rheumatoid arthritis refractory to combination synthetic DMARD therapy.

Methods: This was a prospective observational comparative study conducted at a tertiary care municipal hospital. A total of 74 patients fulfilling the ACR-EULAR 2010 criteria for RA and having DAS28-ESR >3.2 despite ≥3 months of csDMARD therapy were included. Patients were divided into two groups: Group I (n=26) received tofacitinib 5 mg twice daily along with csDMARDs, and Group II (n=48) continued csDMARDs alone. Disease activity was assessed at baseline and after 12 weeks using DAS28-ESR, CDAI, SDAI, ESR, and CRP.

Results: Group I showed a statistically significant reduction in inflammatory markers and disease activity scores at 12 weeks. Remission (DAS28-ESR <2.6) was achieved in 28.57% of patients, while 42.85% achieved low disease activity. In contrast, patients in Group II showed no significant improvement. Overall, 71.42% of tofacitinib-treated patients achieved the EULAR treatment target (p <0.0001). The drug demonstrated a favorable safety profile.

Conclusion: Tofacitinib is an effective and well-tolerated therapeutic option in RA patients refractory to combination synthetic DMARDs, enabling a substantial proportion of patients to achieve remission or low disease activity.