Effectiveness and safety of generic tofacitinib in spondyloarthritis: A real-world retrospective analysis from India.

ABSTRACT

BACKGROUND: Clinical trial evidence demonstrates the efficacy of tofacitinib in ankylosing spondylitis and psoriatic arthritis (PsA). Real-world data from spondyloarthritis (SpA) patients are scarce; there are few reports of its effectiveness and safety from low- to middle-income countries like India, despite its widespread usage. METHODS: This was a retrospective analysis of clinical and laboratory records of 100 patients with SpA prescribed generic tofacitinib from a single center in Mumbai, India. Disease activity was measured using the Ankylosing Spondylitis Disease Activity Score C-Reactive Protein (ASDAS-CRP) in all patients, along with disease-specific outcome measures in the subgroups. We used paired t test for response to tofacitinib. We compared Δ ASDAS-CRP in patients with active peripheral arthritis and in patients without. We defined clinical tofacitinib failure as the physician's decision to change or add a disease-modifying antirheumatic drug (DMARD), and performed logistic regression to identify factors associated with tofacitinib failure. RESULTS: Among 100 patients (71 male, median age 42.5 years), 57 had axial SpA, 10 had peripheral SpA, 4 had inflammatory bowel disease-SpA and 29 had PsA. One-third had received biologic DMARDs previously. Patients received tofacitinib for a median of 192 days. There was a significant improvement in ASDAS-CRP in all types of SpA. Patients with active peripheral arthritis had a significantly greater fall in ASDAS-CRP. There were no serious adverse events, 19 patients had mild COVID-19; no patient had tuberculosis. Ten patients had tofacitinib failure; no baseline parameter could predict failure. INTERPRETATION: In the real-world setting, generic tofacitinib showed good effectiveness and tolerable safety profile in Indian patients with SpA.