TY - JOUR
T1 - The Need for the Closer Monitoring of Novel Drugs in MS :
T2 - A Siponimod Retrospective Cohort Study (Realhes Study)
AU - Sancho-López, Arantxa
AU - Ruiz-Antorán, Belén
AU - Iglesias Hernangómez, Teresa
AU - Ramírez-García, Almudena
AU - Gómez-Estévez, Irene
AU - Sanabria-Cabrera, Judith
AU - Llop Rius, Roser
AU - Pedrós, Consuelo
AU - Campodonico, Diana
AU - Jiménez-Jorge, Silvia
AU - García Luque, Amelia
AU - Costa Frossad França, Lucienne
AU - Montané Esteva, Eva
AU - Aldea-Perona, Ana
AU - Téllez Lara, Nieves
AU - Bosch Ferrer, Montserrat
AU - Rodriguez Jiménez, Consuelo
AU - Bonilla-Toyos, Elvira
AU - Sabín Muñoz, Julia
AU - Avendaño Sola, Cristina
AU - Blasco Quilez, María Rosario
N1 - Publisher Copyright:
© 2023 by the authors.
PY - 2023/10/11
Y1 - 2023/10/11
N2 - 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.
AB - 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.
KW - Lymphopenia
KW - Multiple sclerosis
KW - Pharmacovigilance
KW - Real-world evidence
KW - Siponimod
KW - real-world evidence
KW - multiple sclerosis
KW - pharmacovigilance
KW - lymphopenia
KW - siponimod
UR - http://www.scopus.com/inward/record.url?scp=85175372606&partnerID=8YFLogxK
UR - https://www.mendeley.com/catalogue/8db72271-5903-33e4-b796-bf6281052a52/
UR - https://portalrecerca.uab.cat/en/publications/b353c436-bb29-4437-bace-730742034926
U2 - 10.3390/jcm12206471
DO - 10.3390/jcm12206471
M3 - Article
C2 - 37892611
SN - 2077-0383
VL - 12
JO - Journal of Clinical Medicine
JF - Journal of Clinical Medicine
IS - 20
M1 - 6471
ER -