Background and importance In July 2021, the European Medicines Agency (EMA) and the Spanish Agency for Medicines and Medical Products (AEMPS) notified healthcare professionals of a drug safety warning for tofacitinib that showed new recommendations for its use in relation to an increased risk of major adverse cardiovascular events and malignances with use of tofacitinib relative to tumour necrosis factor alpha (TNFα) inhibitors: “Tofacitinib should not be used in patients older than 65 years of age, people who are current or past smokers, or individuals with other cardiovascular (such as diabetes or coronary artery disease) or malignancy risk factors unless there are no suitable treatment alternatives”.

Aim and objectives The objective of this study was to identify patients at increased risk of major adverse cardiovascular events and malignances who are being treated with tofacitinib in order to communicate this fact to healthcare professionals.

Material and methods Retrospective study of patients under treatment with tofacitinib from January to September 2021. The following factors were considered as risk factors: aged 65 years or more, cardiovascular risk factors, and current malignances. Data were recollected from the patients’ clinical history and local prescription program. We prepared a personalised report that included a summary of the drug safety warning and the patients under treatment that were considered to be at risk to each healthcare professional, offering them other treatment options based on efficacy, safety and cost.

Results We reviewed 36 patients under treatment with tofacitinib, 28 females (73%), average age 51.6 years. 32 patients had rheumatoid arthritis and 4 patients had ulcerative colitis. We identified 13 (36%) patients with an increased risk of major adverse cardiovascular events and malignances, and all of them had rheumatoid arthritis: 7 patients were aged 65+ years, 5 patients had cardiovascular risk factors, and 2 patients had a malignancy process. We sent 11 personalised reports to healthcare professionals.

Conclusion and relevance One in three patients being treated with tofacitinib were affected by the security alert, and were considered to be a population at increased risk of major adverse cardiovascular events and malignances. This study allowed us to find these patients and communicate this information to healthcare professionals, providing them with an alternative treatment option based on efficacy, safety and cost.

References and/or acknowledgements https://www.aemps.gob.es/informa/notasinformativas/medicamentosusohumano-3/seguridad-1/2021-seguridad-1/xeljanz-tofacitinib-nuevas-precauciones-de-uso/

Conflict of interest No conflict of interest