Real-world evidence of the effectiveness and safety of generic tofacitinib in rheumatoid arthritis patients: a retrospective, single-centre analysis from Western India

Abstract

Generic tofacitinib has been available in India for more than a year and is widely used in rheumatoid arthritis (RA) therapy. There is scarce real-world data on its effectiveness and safety from India, especially given infection endemicity. We retrospectively analysed records (demographic and clinical information, haematology and biochemistry, adverse events) of patients prescribed generic tofacitinib from a single centre in Mumbai, India. Disease activity was calculated using the disease activity score-28 and erythrocyte sedimentation rate (DAS28-ESR) and other tools, and we used paired T-tests for significant response. We defined clinical tofacitinib failure as a composite outcome, including clinician's decision to change to an alternative disease-modifying anti-rheumatic drug (DMARD) or flare after self-withdrawal. We performed logistic regression and survival analysis for determinants of clinical failure. We reviewed records of 102 patients (92 female; median age: 53 years) with mean RA duration of 146 months. Thirteen had prior treatment with innovator tofacitinib. There was significant improvement in disease activity parameters at a mean duration of 186 days. No serious adverse events were reported; 4 patients had tuberculosis and 19 patients had mild COVID-19 while on treatment. Clinical failure was seen in 25 patients, and mean time to failure on survival analysis was 357 days. No baseline characteristic predicted clinical failure. Generic tofacitinib showed good effectiveness and a tolerable adverse effect profile, despite tuberculosis endemicity and COVID-19. Setting up registries would be valuable in gaining more data on generic tofacitinib. Key Points• There is scarce data from India regarding the use of tofacitinib in rheumatoid arthritis, despite widespread use.• In this retrospective analysis of 102 patients at a single centre, we found tofacitinib monotherapy was efficacious and tolerable.• Tuberculosis was detected in four and nineteen patients had mild covid.

Comparative Effectiveness of Tofacitinib and Adalimumab in Axial Spondyloarthritis

“…Availability of generic tofacitinib in India made the cost of therapy markedly less as compared with the originator tofacitinib molecule. 8 Thus, tofacitinib has become an often-prescribed drug in active AxSpA. In our ICER drug analysis, at least in the current Indian context, ICER drug of tofacitinib was favorable compared with adalimumab.…”

“…Successful treatment of AxSpA was difficult in the recent past in resource-poor settings, because after NSAID failure, the only choice was biologics (or biosimilars), which are expensive. Availability of generic tofacitinib in India made the cost of therapy markedly less as compared with the originator tofacitinib molecule 8 . Thus, tofacitinib has become an often-prescribed drug in active AxSpA.…”

“…7 Since November 2020, generic tofacitinib is available in the Indian market with economic pricing than the originator brand, resulting in its increased use in rheumatologic diseases, including RA and spondyloarthritis. 8 In India, monthly cost of therapy with biosimilar adalimumab is presently higher than that of tofacitinib, which in conjunction with the convenience of oral administration of tofacitinib makes it an attractive choice for patients. However, there is no comparison of effectiveness between tofacitinib and adalimumab in AxSpA or in terms of cost-effectiveness.…”

“…In India, adalimumab biosimilars, approved as per the guidelines of the Department of Biotechnology and the Central Drugs Standard Control Organization, Government of India, are available since 2014 7 . Since November 2020, generic tofacitinib is available in the Indian market with economic pricing than the originator brand, resulting in its increased use in rheumatologic diseases, including RA and spondyloarthritis 8 …”