Year: 2025
Type: conference-paper
Study design: Observational Study
Abstract: Background and Importance Following the issuance of a Safety Alert (MUH (FV), 08/2022) by the Spanish Medicines Agency (AEMPS) in November 2022, which reported the risk of major adverse cardiovascular events and malignant neoplasms in patients treated with JAK inhibitors (iJAK), a series of recommendations were established regarding their use in patients over 65 years and with cardiovascular risk factors (CVRF) or for the development of neoplasms. Aim and Objectives Evaluate the appropriate use of iJAK in a tertiary hospital according to the new recommendations of the AEMPS regarding the increased risk of major adverse cardiovascular events and malignant neoplasms described in patients with CVRF or for the development of neoplasms. Material and Methods Retrospective observational study of patients treated with iJAK baricitinib, tofacitinib, upadacitinib and filgotinib from July 2021 to March 2024. We analysed which patients continued with iJAK after the AEMPS recommendation despite having risk factors and whether or not they had a therapeutic alternative. Sources consulted: the Outpatient Management module of Farmatools, the computerised clinical history of the patients and the iJAK technical sheet. Data Analysis: Excel Variables collected: age, sex, risk factors for major adverse cardiovascular events and malignant neoplasms (history of cardiovascular disease or neoplasia, CVRF, smoker/ex-smoker) and existence of a treatment alternative; before and after the Health Alert. Results 151 patients with a mean age of 52 years were studied. 104 (69%) were women. Before the alert, 96 patients were treated with an iJAK. Of them, 68 (71%) had some RF. Of these, 18 (26%) discontinued JAKi treatment. Of those who continued, 20 (41%) had a therapeutic alternative and 29 (59%) did not. After the alert, 64 patients started treatment with iJAK. Of these, 31 (48%) had some risk factors, 13 (42%) with treatment alternatives and 18 (58%) without alternatives. Comparison of patients before and after the alert: Before: 71% with risk factors, of which 30% had a treatment alternative. After: 63% with risk factors, of which 40% had a treatment alternative. Conclusion and Relevance No significant changes were observed after the alert described, with the benefit of the treatment being valued more than the risk. The presence of a multidisciplinary team in which the pharmacist is integrated could be interesting when proposing therapeutic alternatives that guarantee patient safety. References and/or Acknowledgements Conflict of Interest No conflict of interest
Authors: L Cuerpo, JL Sánchez Serrano, A Drozdz Vergara, MJ De Mora, IC Torres Tendero, N Clemente Pradillo
Institution: Complejo Hospitalario Universitario de Albacete
Language: English
Subfield: Rheumatology
Field: Medicine
Domain: Health Sciences
Open Access status: gold
OpenAlex ID: W4408377074