Clinical experience of tofacitinib in rheumatoid arthritis: Real-world data from 2 centres in South India

Background: Tofacitinib is an oral Janus kinase inhibitor for the treatment of Rheumatoid Arthritis (RA). It has demonstrated efficacy and manageable safety in multiple phase I-III trials and long term extension studies extending over 8 years. Real world data with Tofacitinib is limited and published Indian data is unavailable. Objectives: Evaluation of efficacy and safety of Tofacitinib in patients with RA not responding to conventional synthetic disease modifying anti rheumatic drugs (csDMARDs) or biologics (bDMARDs) in routine clinical practice. Methods: Retrospective data from 2 centers in South India was studied where Tofacitinib was given 5 mg twice daily orally to patients with RA who did not respond to csDMARDs/bDMARDs. Efficacy and safety data was obtained using standardized formats at baseline, 1month and 3months. Results: Data of 35 patients treated with Tofacitinib from Oct 2016 to June 2017 was analyzed. Mean age was 54 years (26-76), most were females (32/35), average duration of RA 11.5 years (2-30), 34/35 were seropositive (RF/ACCP) and 32/35 had erosive arthritis. All the patients were inadequate responders (IR) to Methotrexate (average dose 15-20 mg/wk) or to combination csDMARDs. Thirteen (37%) patients were bDMARDs IR- Etanercept 3, Tocilizumab 4, Abatacept 3, Golimumab 2 and Rituximab 1. Seven patients experienced bDMARDs (all Etanercept) were not IR but chose Tofacitinib for convenient oral medication. All patients received Tofacitinib along with csDMARDs and were evaluated before and after treatment [Table 1 and Graph]. Mild and reversible adverse events noted were herpes simplex (1), headache (1), feet skin pigmentation (1), gingivitis (1), neck pain (1), pharyngitis (1), alopecia (1) and hypertriglyceridemia (1). One patient with recurrent upper respiratory infection stopped Tofacitinib after 3 months and one patient with severe thrombocytopenia (<20,000) stopped after 2 months. Two patients were lost to follow up after receiving therapy for 1 month who felt better. Conclusion: Patients with severe RA showed good EULAR response as early as one month and continued to show improvement by the end of 3 months. No new safety signals were identified. Present real-world data is reassuring but it needs more experience among the rheumatologists over longer treatment duration (Table presented).