dc.contributor
Institut Català de la Salut
dc.contributor
[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
dc.contributor
Vall d'Hebron Barcelona Hospital Campus
dc.contributor.author
Sancho-López, Arantxa
dc.contributor.author
Ruiz-Antorán, Belén
dc.contributor.author
Iglesias Hernangómez, Teresa
dc.contributor.author
Ramírez-García, Almudena
dc.contributor.author
Gómez-Estévez, Irene
dc.contributor.author
Sanabria, Judith
dc.contributor.author
Bosch Ferrer, Montserrat
dc.date.accessioned
2024-06-06T13:36:41Z
dc.date.available
2024-06-06T13:36:41Z
dc.date.issued
2023-11-10T08:05:44Z
dc.date.issued
2023-11-10T08:05:44Z
dc.date.issued
2023-10-11
dc.identifier
Sancho-López A, Ruiz-Antorán B, Iglesias Hernangómez T, Ramírez-García A, Gómez-Estévez I, Sanabria-Cabrera J, et al. The Need for the Closer Monitoring of Novel Drugs in MS: A Siponimod Retrospective Cohort Study (Realhes Study). J Clin Med. 2023 Oct 11;12(20):6471.
dc.identifier
https://hdl.handle.net/11351/10590
dc.identifier
10.3390/jcm12206471
dc.identifier.uri
http://hdl.handle.net/11351/10590
dc.description.abstract
Lymphopenia; Multiple sclerosis; Pharmacovigilance
dc.description.abstract
Linfopenia; Esclerosis múltiple; Farmacovigilancia
dc.description.abstract
Limfopènia; Esclerosi múltiple; Farmacovigilància
dc.description.abstract
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.
dc.format
application/pdf
dc.relation
Journal of Clinical Medicine;12(20)
dc.relation
https://doi.org/10.3390/jcm12206471
dc.rights
Attribution 4.0 International
dc.rights
http://creativecommons.org/licenses/by/4.0/
dc.rights
info:eu-repo/semantics/openAccess
dc.subject
Farmacovigilància
dc.subject
Esclerosi múltiple - Tractament
dc.subject
DISEASES::Nervous System Diseases::Autoimmune Diseases of the Nervous System::Demyelinating Autoimmune Diseases, CNS::Multiple Sclerosis
dc.subject
Other subheadings::Other subheadings::Other subheadings::/drug therapy
dc.subject
ANALYTICAL, DIAGNOSTIC AND THERAPEUTIC TECHNIQUES, AND EQUIPMENT::Investigative Techniques::Evaluation Studies as Topic::Product Surveillance, Postmarketing::Pharmacovigilance
dc.subject
ENFERMEDADES::enfermedades del sistema nervioso::enfermedades autoinmunitarias del sistema nervioso::enfermedades autoinmunes desmielinizantes del SNC::esclerosis múltiple
dc.subject
Otros calificadores::Otros calificadores::Otros calificadores::/farmacoterapia
dc.subject
TÉCNICAS Y EQUIPOS ANALÍTICOS, DIAGNÓSTICOS Y TERAPÉUTICOS::técnicas de investigación::estudios de evaluación como asunto::vigilancia de productos comercializados::farmacovigilancia
dc.title
The Need for the Closer Monitoring of Novel Drugs in MS: A Siponimod Retrospective Cohort Study (Realhes Study)
dc.type
info:eu-repo/semantics/article
dc.type
info:eu-repo/semantics/publishedVersion
