Impact in Clinical Practice of the European Medicines Agency Health Alert About the Restriction of the Use of JAK Inhibitors
<b>Background/Objectives:</b> Janus kinase inhibitors (JAKi) have revolutionized the treatment of various inflammatory and immune disorders. Concerns about the potential increased risk of major adverse cardiovascular events (MACEs) associated with JAKi use led to a European Medicines Age...
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MDPI AG
2024-12-01
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| Online Access: | https://www.mdpi.com/1424-8247/18/1/22 |
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| author | Elisabet Castañeda-Estévez Cristina Vergara-Dangond Martina Steiner Maria Beatriz Paredes-Romero Ana Esteban-Vázquez Tatiana Cobo-Ibañez Laura Trives-Folguera Maria Liz Romero-Bogado Isabel De La Cámara-Fernández Patricia Richi-Alberti Ana Acosta-Alfaro Iría De la Osa-Subtil Santiago Muñoz-Fernández |
| author_facet | Elisabet Castañeda-Estévez Cristina Vergara-Dangond Martina Steiner Maria Beatriz Paredes-Romero Ana Esteban-Vázquez Tatiana Cobo-Ibañez Laura Trives-Folguera Maria Liz Romero-Bogado Isabel De La Cámara-Fernández Patricia Richi-Alberti Ana Acosta-Alfaro Iría De la Osa-Subtil Santiago Muñoz-Fernández |
| author_sort | Elisabet Castañeda-Estévez |
| collection | DOAJ |
| description | <b>Background/Objectives:</b> Janus kinase inhibitors (JAKi) have revolutionized the treatment of various inflammatory and immune disorders. Concerns about the potential increased risk of major adverse cardiovascular events (MACEs) associated with JAKi use led to a European Medicines Agency (EMA) health alert recommending restricting the use of JAKi in high-risk populations. <b>Methods:</b> This study aims to determine the proportion of patients who developed any cardiovascular, ischemic, neoplastic, or thrombotic adverse event in a cohort of patients receiving, or who have received, JAKi treatment between January 2017 and September 2023. In addition, we studied the impact of the alert in the clinical practice of our Rheumatology department. <b>Results:</b> In this retrospective, observational study, 101 patients were analysed, predominantly women (72.3%), with a mean age of 57.6 years. The most common diagnoses were rheumatoid arthritis (60.4%) and psoriatic arthritis (18.8%). The most frequent adverse events were infections (5.9%) and neoplasms (2.9%). Deep vein thrombosis and haemorrhagic stroke each occurred in 1% of patients, with no cases of ischemic stroke or ischemic heart disease. When the health alert was published, 75 patients were on treatment with JAKi, and 33 met the alert criteria. Of these, 12.1% changed treatment due to the alert, 9% had no other therapeutic options, 57.5% were in clinical remission or had low disease activity, and 9% maintained treatment at their own request. <b>Conclusions:</b> These findings suggest that, in this patient cohort, JAKi use did not result in new MACE cases. The alert concerning the use of JAKi has had a limited impact in our clinical practice. |
| format | Article |
| id | doaj-art-dc45959674da44d0ad274f221116e941 |
| institution | Kabale University |
| issn | 1424-8247 |
| language | English |
| publishDate | 2024-12-01 |
| publisher | MDPI AG |
| record_format | Article |
| series | Pharmaceuticals |
| spelling | doaj-art-dc45959674da44d0ad274f221116e9412025-01-24T13:45:02ZengMDPI AGPharmaceuticals1424-82472024-12-011812210.3390/ph18010022Impact in Clinical Practice of the European Medicines Agency Health Alert About the Restriction of the Use of JAK InhibitorsElisabet Castañeda-Estévez0Cristina Vergara-Dangond1Martina Steiner2Maria Beatriz Paredes-Romero3Ana Esteban-Vázquez4Tatiana Cobo-Ibañez5Laura Trives-Folguera6Maria Liz Romero-Bogado7Isabel De La Cámara-Fernández8Patricia Richi-Alberti9Ana Acosta-Alfaro10Iría De la Osa-Subtil11Santiago Muñoz-Fernández12Department of Rheumatology, Hospital Universitario Infanta Sofía, FIIB HUIS HHEN, Universidad Europea, 28702 Madrid, SpainDepartment of Rheumatology, Hospital Universitario Infanta Sofía, FIIB HUIS HHEN, Universidad Europea, 28702 Madrid, SpainDepartment of Rheumatology, Hospital Universitario Infanta Sofía, FIIB HUIS HHEN, Universidad Europea, 28702 Madrid, SpainDepartment of Rheumatology, Hospital Universitario Infanta Sofía, FIIB HUIS HHEN, Universidad Europea, 28702 Madrid, SpainDepartment of Rheumatology, Hospital Universitario Infanta Sofía, FIIB HUIS HHEN, Universidad Europea, 28702 Madrid, SpainDepartment of Rheumatology, Hospital Universitario Infanta Sofía, FIIB HUIS HHEN, Universidad Europea, 28702 Madrid, SpainDepartment of Rheumatology, Hospital Universitario Infanta Sofía, FIIB HUIS HHEN, Universidad Europea, 28702 Madrid, SpainDepartment of Rheumatology, Hospital Universitario Infanta Sofía, FIIB HUIS HHEN, Universidad Europea, 28702 Madrid, SpainDepartment of Rheumatology, Hospital Universitario Infanta Sofía, FIIB HUIS HHEN, Universidad Europea, 28702 Madrid, SpainDepartment of Rheumatology, Hospital Universitario Infanta Sofía, FIIB HUIS HHEN, Universidad Europea, 28702 Madrid, SpainDepartment of Rheumatology, Hospital Universitario Infanta Sofía, FIIB HUIS HHEN, Universidad Europea, 28702 Madrid, SpainDepartment of Medicine, Faculty of Biomedical and Health Sciences, European University of Madrid, 28670 Madrid, SpainDepartment of Rheumatology, Hospital Universitario Infanta Sofía, FIIB HUIS HHEN, Universidad Europea, 28702 Madrid, Spain<b>Background/Objectives:</b> Janus kinase inhibitors (JAKi) have revolutionized the treatment of various inflammatory and immune disorders. Concerns about the potential increased risk of major adverse cardiovascular events (MACEs) associated with JAKi use led to a European Medicines Agency (EMA) health alert recommending restricting the use of JAKi in high-risk populations. <b>Methods:</b> This study aims to determine the proportion of patients who developed any cardiovascular, ischemic, neoplastic, or thrombotic adverse event in a cohort of patients receiving, or who have received, JAKi treatment between January 2017 and September 2023. In addition, we studied the impact of the alert in the clinical practice of our Rheumatology department. <b>Results:</b> In this retrospective, observational study, 101 patients were analysed, predominantly women (72.3%), with a mean age of 57.6 years. The most common diagnoses were rheumatoid arthritis (60.4%) and psoriatic arthritis (18.8%). The most frequent adverse events were infections (5.9%) and neoplasms (2.9%). Deep vein thrombosis and haemorrhagic stroke each occurred in 1% of patients, with no cases of ischemic stroke or ischemic heart disease. When the health alert was published, 75 patients were on treatment with JAKi, and 33 met the alert criteria. Of these, 12.1% changed treatment due to the alert, 9% had no other therapeutic options, 57.5% were in clinical remission or had low disease activity, and 9% maintained treatment at their own request. <b>Conclusions:</b> These findings suggest that, in this patient cohort, JAKi use did not result in new MACE cases. The alert concerning the use of JAKi has had a limited impact in our clinical practice.https://www.mdpi.com/1424-8247/18/1/22JAK inhibitorscardiovascular riskhealth alert |
| spellingShingle | Elisabet Castañeda-Estévez Cristina Vergara-Dangond Martina Steiner Maria Beatriz Paredes-Romero Ana Esteban-Vázquez Tatiana Cobo-Ibañez Laura Trives-Folguera Maria Liz Romero-Bogado Isabel De La Cámara-Fernández Patricia Richi-Alberti Ana Acosta-Alfaro Iría De la Osa-Subtil Santiago Muñoz-Fernández Impact in Clinical Practice of the European Medicines Agency Health Alert About the Restriction of the Use of JAK Inhibitors Pharmaceuticals JAK inhibitors cardiovascular risk health alert |
| title | Impact in Clinical Practice of the European Medicines Agency Health Alert About the Restriction of the Use of JAK Inhibitors |
| title_full | Impact in Clinical Practice of the European Medicines Agency Health Alert About the Restriction of the Use of JAK Inhibitors |
| title_fullStr | Impact in Clinical Practice of the European Medicines Agency Health Alert About the Restriction of the Use of JAK Inhibitors |
| title_full_unstemmed | Impact in Clinical Practice of the European Medicines Agency Health Alert About the Restriction of the Use of JAK Inhibitors |
| title_short | Impact in Clinical Practice of the European Medicines Agency Health Alert About the Restriction of the Use of JAK Inhibitors |
| title_sort | impact in clinical practice of the european medicines agency health alert about the restriction of the use of jak inhibitors |
| topic | JAK inhibitors cardiovascular risk health alert |
| url | https://www.mdpi.com/1424-8247/18/1/22 |
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