The Need for the Closer Monitoring of Novel Drugs in MS : A Siponimod Retrospective Cohort Study (Realhes Study)
Sancho López, Aranzazu (Hospital Universitario Puerta de Hierro Majadahonda (Madrid))
Ruiz-Antorán, Belén (Hospital Universitario Puerta de Hierro Majadahonda (Madrid))
Iglesias Hernangómez, Teresa (Hospital Universitario Clínico San Carlos (Madrid))
Ramírez-García, Almudena (Hospital Universitario Puerta de Hierro Majadahonda (Madrid))
Gómez-Estévez, Irene (Universidad Complutense de Madrid)
Sanabria-Cabrera, Judith (Plataforma ISCIII de Investigación Clínica)
Llop Rius, Roser (Hospital Universitari de Bellvitge)
Pedrós, Consuelo (Hospital General Universitario de Valencia)
Campodonico, Diana (Hospital Universitario de la Princesa (Madrid))
Jiménez-Jorge, Silvia (Hospital Universitario Virgen del Rocío (Sevilla, Andalusia))
García Luque, Amelia (University of Alcalá (IRYCIS))
Costa-Frossard, Lucienne (Hospital Universitario Ramón y Cajal (Madrid))
Montané Esteva, Eva (Institut Germans Trias i Pujol. Hospital Universitari Germans Trias i Pujol)
Aldea-Perona, Ana (Hospital del Mar (Barcelona, Catalunya))
Téllez Lara, Nieves (Hospital Clínico Universitario de Valladolid)
Bosch Ferrer, Montserrat (Hospital Universitari Vall d'Hebron. Institut de Recerca)
Rodriguez Jiménez, Consuelo (Complejo Hospitalario Universitario e Canarias)
Bonilla-Toyos, Elvira (Plataforma ISCIII de Investigación Clínica)
Sabín Muñoz, Julia (Hospital Universitario Puerta de Hierro Majadahonda (Madrid))
Avendaño Sola, Cristina (Hospital Universitario Puerta de Hierro Majadahonda (Madrid))
Blasco Quilez, María Rosario (Hospital Universitario Puerta de Hierro Majadahonda (Madrid))
Universitat Autònoma de Barcelona

Fecha:	2023
Resumen:	Severe cases of lymphopenia have been reported during siponimod clinical trials, which may negatively impact its benefit/risk profile. 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. 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. 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.
Derechos:	Aquest document està subjecte a una llicència d'ús Creative Commons. Es permet la reproducció total o parcial, la distribució, la comunicació pública de l'obra i la creació d'obres derivades, fins i tot amb finalitats comercials, sempre i quan es reconegui l'autoria de l'obra original.
Lengua:	Anglès
Documento:	Article ; recerca ; Versió publicada
Materia:	Lymphopenia ; Multiple sclerosis ; Pharmacovigilance ; Real-world evidence ; Siponimod
Publicado en:	Journal of clinical medicine, Vol. 12 (october 2023) , ISSN 2077-0383

DOI: 10.3390/jcm12206471
PMID: 37892611

12 p, 1.3 MB

El registro aparece en las colecciones:
Documentos de investigación > Documentos de los grupos de investigación de la UAB > Centros y grupos de investigación (producción científica) > Ciencias de la salud y biociencias > Institut d'Investigació en Ciencies de la Salut Germans Trias i Pujol (IGTP)
Artículos > Artículos de investigación
Artículos > Artículos publicados