ABSTRACT
Background: Tofacitinib is a targeted synthetic DMARD that selectively inhibits Janus kinase (JAK) and is approved for the treatment of RA by the FDA in 2012. In recent years, an important safety concern related to incidence of adverse events after treatment with tofacitinib has emerged. Objectives: To evaluate the risk of major adverse cardiovascular events (MACE), venous thromboembolism (pulmonary embolism or deep vein thrombosis), serious infections requiring hospitalization, and herpes zoster with tofacitinib in RA patients aged ≥ 60 years. Methods: HUR-BIO (Hacettepe University Rheumatology Biologic Registry) is a single center biological and targeted synthetic DMARD registry since 2005. We analyzed RA patients aged ≥ 60 years receiving tofacitinib who had at least 1 control visit registered in the HURBIO database. Phone calls were made with these patients for the current health status information until the end of January 2022. The data of the patients who lost the follow-up in our clinic were obtained from the personal health record system of the Republic of Turkey Ministry of Health by patients' permission. The coprimary end points were adjudicated MACE, VTE, serious infections, and herpes zoster. These events were identi-fed using patients' medical records. Crude incidence rates were expressed in patients with frst events per 100 patient-years, with two-sided 95% confdence intervals. Results: A total of 132 RA patients (109, 82.6% female) aged ≥ 60 years received tofacitinib at a dose of 5 mg twice daily. The median (25-75% percentiles) age was 67 (63-73) years and median duration under tofacitinib was 18 (5-33) months. Approximately 70% of patients were biologically naive. During a median follow-up of 1. 5 years, the incidences of serious infection requiring hospitalization and herpes zoster were higher (5.5% [95%CI 3.12-9.86] and 3.4% [1.67-7.17], respectively) while there was no increase in the incidences of MACE and VTE. The causes for hospitalization were as follows: COVID-19 (n=4), pneumonia (n=3), soft-tissue infection (n=3), and GIS infection (n=1). Tw o of these patients deceased. Conclusion: Older patients with RA are at increased infection risk because of age and comorbid conditions. Although adverse events are reported with 10 mg tofacitinib twice daily, clinicians should be careful against the risk of infection at a dose of 5 mg twice daily, especially in elderly patients.