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

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 objectiv...

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Autores principales: Sancho-López, Arantxa, Ruiz-Antorán, Belén, Iglesias 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 Frossad França, 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
Formato: Online Artículo Texto
Lenguaje:English
Publicado: MDPI 2023
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10607533/
https://www.ncbi.nlm.nih.gov/pubmed/37892611
http://dx.doi.org/10.3390/jcm12206471
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author Sancho-López, Arantxa
Ruiz-Antorán, Belén
Iglesias 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 Frossad França, 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
author_facet Sancho-López, Arantxa
Ruiz-Antorán, Belén
Iglesias 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 Frossad França, 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
author_sort Sancho-López, Arantxa
collection PubMed
description 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.
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spelling pubmed-106075332023-10-28 The Need for the Closer Monitoring of Novel Drugs in MS: A Siponimod Retrospective Cohort Study (Realhes Study) Sancho-López, Arantxa Ruiz-Antorán, Belén Iglesias 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 Frossad França, 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 J Clin Med Article 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. MDPI 2023-10-11 /pmc/articles/PMC10607533/ /pubmed/37892611 http://dx.doi.org/10.3390/jcm12206471 Text en © 2023 by the authors. https://creativecommons.org/licenses/by/4.0/Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (https://creativecommons.org/licenses/by/4.0/).
spellingShingle Article
Sancho-López, Arantxa
Ruiz-Antorán, Belén
Iglesias 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 Frossad França, 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
The Need for the Closer Monitoring of Novel Drugs in MS: A Siponimod Retrospective Cohort Study (Realhes Study)
title The Need for the Closer Monitoring of Novel Drugs in MS: A Siponimod Retrospective Cohort Study (Realhes Study)
title_full The Need for the Closer Monitoring of Novel Drugs in MS: A Siponimod Retrospective Cohort Study (Realhes Study)
title_fullStr The Need for the Closer Monitoring of Novel Drugs in MS: A Siponimod Retrospective Cohort Study (Realhes Study)
title_full_unstemmed The Need for the Closer Monitoring of Novel Drugs in MS: A Siponimod Retrospective Cohort Study (Realhes Study)
title_short The Need for the Closer Monitoring of Novel Drugs in MS: A Siponimod Retrospective Cohort Study (Realhes Study)
title_sort need for the closer monitoring of novel drugs in ms: a siponimod retrospective cohort study (realhes study)
topic Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10607533/
https://www.ncbi.nlm.nih.gov/pubmed/37892611
http://dx.doi.org/10.3390/jcm12206471
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