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Wiley, International Journal of Rheumatic Diseases, 3(26), p. 487-492, 2023

DOI: 10.1111/1756-185x.14570

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

Journal article published in 2023 by Sanat Phatak ORCID, Aditya Khenat, Mansi Malandkar, Sanjiv Amin
This paper was not found in any repository, but could be made available legally by the author.
This paper was not found in any repository, but could be made available legally by the author.

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Abstract

AbstractBackgroundClinical 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.MethodsThis 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.ResultsAmong 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.InterpretationIn the real‐world setting, generic tofacitinib showed good effectiveness and tolerable safety profile in Indian patients with SpA.