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jcm-12-06471-v2.pdf (1.29 MB)

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2023-10-11

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cc by (c) Sancho López, Arantxa et al., 2023
Si us plau utilitzeu sempre aquest identificador per citar o enllaçar aquest document: https://hdl.handle.net/2445/204164

The Need for the Closer Monitoring of Novel Drugs in MS: A Siponimod Retrospective Cohort Study (Realhes Study)

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https://doi.org/10.3390/jcm12206471

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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.

Matèries

Limfòcits, Esclerosi múltiple

Matèries (anglès)

Lymphocytes, Multiple sclerosis

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Articles publicats en revistes (Institut d'lnvestigació Biomèdica de Bellvitge (IDIBELL))

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SANCHO LÓPEZ, Arantxa, RUIZ ANTORÁN, Belén, HERNANGÓMEZ, Teresa, RAMÍREZ GARCÍA, Almudena, GÓMEZ ESTÉVEZ, Irene, SANABRIA CABRERA, Judith, LLOP RIUS, Roser, PEDRÓS, Consuelo, CAMPODONICO, Diana, JIMÉNEZ JORGE, Silvia, GARCÍA LUQUE, Amelia, COSTA FROSSARD, Lucienne, MONTANÉ, Eva, ALDEA PERONA, Ana, TÉLLEZ LARA, Nieves, BOSCH FERRER, Montserrat, RODRIGUEZ JIMÉNEZ, Consuelo, BONILLA TOYOS, Elvira, SABÍN MUÑOZ, Julia, AVENDAÑO SOLÁ, Cristina, BLASCO QUILEZ, María rosario, REALHES-Study Group. The Need for the Closer Monitoring of Novel Drugs in MS: A Siponimod Retrospective Cohort Study (Realhes Study). _Journal of Clinical Medicine_. 2023. Vol. 12, núm. 20. [consulta: 26 de febrer de 2026]. ISSN: 2077-0383. [Disponible a: https://hdl.handle.net/2445/204164]

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