Tofacitinib in the treatment of rheumatoid arthritis: real-life practice and randomized clinical trial data

Abstract

The article justifies the need for a large arsenal of drugs to treat perennial rheumatoid arthritis. The authors present randomized controlled trial data showing high efficacy of tofacitinib at different doses as monotherapy, or in combination with methotrexate, or other conventional synthetic disease-modifying anti-inflammatory drugs in suppressing the activity and progression of the disease in various groups of patients, both non-responders to methotrexate, and non-responders to tumour necrosis factor-alpha inhibitors. Extension-phase data of randomized clinical trials demonstrated sustained efficacy of tofacitinib for up to 9.5 years. The authors presented the real-world evidence confirming high efficiency of the drug and noted the rapidity of onset of the effect and its high analgesic activity. The safety issues of tofacitinib with an emphasis on the cardiovascular safety of the drug, taking into account updates to the latest 2022 EULAR Recommendations on the need to consider risk factors for the development of cardiovascular adverse events when planning therapy with Janus kinase inhibitors are discussed. It is reported that slightly increased risk of such adverse events during use of tofacitinib, as compared with inhibitors of tumour necrosis factor alpha, was observed in elderly patients who have at least one risk factor for the development of cardiovascular events. Tofacitinib safety data were obtained from meta-analyses, systematic reviews, national registries, open observational studies, as well as outcomes of the use of the drug in real clinical practice. The launch of a domestic generic of the original drug was noted in the Russian Federation.