Sistema de Salut de Catalunya
Institut Català de la Salut
[Sancho-López A, Ruiz-Antorán B, Ramírez-García A] Clinical Pharmacology Department, Hospital Universitario Puerta de Hierro-Majadahonda, Instituto de Investigación Sanitaria Puerta de Hierro-Segovia de Arana, Majadahonda, Spain. [Iglesias Hernangómez T] Clinical Pharmacology Department, Hospital Universitario Clínico San Carlos, Madrid, Spain. [Gómez-Estévez I] Department of Neurology, Hospital Clinico San Carlos, IdISSC, Madrid, Spain. Department of Medicine, Facultad de Medicina, Universidad Complutense de Madrid (UCM), Madrid, Spain. [Sanabria-Cabrera J] Clinical Pharmacology Department, Hospital Universitario Virgen de la Victoria, IBIMA_Plataforma BIONAND, Universidad de Málaga, Malaga, Spain. Platform for Clinical Research and Clinical Trials IBIMA, Plataforma ISCIII de Investigación Clínica, Madrid, Spain. [Bosch Ferrer M] Departament de Farmacologia, Terapèutica i Toxicologia, Universitat Autònoma de Barcelona, Bellaterra, Spain. Servei de Farmacologia Clínica, Vall d’Hebron Hospital Universitari, Barcelona, Spain. Grup de Farmacologia Clínica, Vall d’Hebron Institut de Recerca (VHIR), Barcelona, Spain
Vall d'Hebron Barcelona Hospital Campus
2023-11-10T08:05:44Z
2023-11-10T08:05:44Z
2023-10-11
Lymphopenia; Multiple sclerosis; Pharmacovigilance
Linfopenia; Esclerosis múltiple; Farmacovigilancia
Limfopènia; Esclerosi múltiple; Farmacovigilància
Background: Severe cases of lymphopenia have been reported during siponimod clinical trials, which may negatively impact its benefit/risk profile. Objective: We aimed to evaluate the incidence of lymphopenia following the initiation of siponimod treatment in clinical practice. The secondary objectives included the analysis of factors predisposing to and the clinical relevance of lymphopenia events. Methods: In this multicenter retrospective cohort study, information collected from the medical records of 129 patients with MS from 15 tertiary hospitals in Spain who initiated treatment with Siponimod were followed-up for at least 3 months, including at least one lymphocyte count evaluation per patient. Results: Of the 129 patients, 121 (93.6%) reported lymphopenia events, including 110 (85.3%) with grade ≤ 3 and 11 (8.5%) with grade 4 lymphopenia, higher than those reported in the pivotal clinical trial (73.3% and 3.3% for grade ≤ 3 and grade 4 lymphopenia, respectively). The study included an unexpectedly high proportion of male subjects (72.9%), which might have led to an underestimation of the actual magnitude of the risk. Conclusions: In this study, the incidence and severity of lymphopenia after starting siponimod treatment were higher than those reported in previous clinical trials. Therefore, our results reinforce the need for the closer monitoring of novel MS drugs in clinical practice, as well as larger and longer follow-up studies to properly characterize this risk.
Article
Published version
English
Farmacovigilància; Esclerosi múltiple - Tractament; DISEASES::Nervous System Diseases::Autoimmune Diseases of the Nervous System::Demyelinating Autoimmune Diseases, CNS::Multiple Sclerosis; Other subheadings::Other subheadings::Other subheadings::/drug therapy; ANALYTICAL, DIAGNOSTIC AND THERAPEUTIC TECHNIQUES, AND EQUIPMENT::Investigative Techniques::Evaluation Studies as Topic::Product Surveillance, Postmarketing::Pharmacovigilance; ENFERMEDADES::enfermedades del sistema nervioso::enfermedades autoinmunitarias del sistema nervioso::enfermedades autoinmunes desmielinizantes del SNC::esclerosis múltiple; Otros calificadores::Otros calificadores::Otros calificadores::/farmacoterapia; TÉCNICAS Y EQUIPOS ANALÍTICOS, DIAGNÓSTICOS Y TERAPÉUTICOS::técnicas de investigación::estudios de evaluación como asunto::vigilancia de productos comercializados::farmacovigilancia
MDPI
Journal of Clinical Medicine;12(20)
https://doi.org/10.3390/jcm12206471
Attribution 4.0 International
http://creativecommons.org/licenses/by/4.0/
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