Adolfo Del Canto, Claudia Cárcamo, Lorena Garcia, Ester Aylwin, Lukas Jürgensen-Heinrich, Ignacio Guzman-Carcamo, Juan de la Barra, Leticia Gutierrez-Calquin, Antonia Barrera-Hormazabal, Juan Pablo Cruz, Sebastián Bravo, Carolina Pelayo, Bernardita Soler, Reinaldo Uribe-San-Martin, Ethel Ciampi
{"title":"Real-world evidence of ocrelizumab in Chilean patients with multiple sclerosis.","authors":"Adolfo Del Canto, Claudia Cárcamo, Lorena Garcia, Ester Aylwin, Lukas Jürgensen-Heinrich, Ignacio Guzman-Carcamo, Juan de la Barra, Leticia Gutierrez-Calquin, Antonia Barrera-Hormazabal, Juan Pablo Cruz, Sebastián Bravo, Carolina Pelayo, Bernardita Soler, Reinaldo Uribe-San-Martin, Ethel Ciampi","doi":"10.1177/13524585241309835","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>Real-world studies are needed to expand our knowledge concerning populations underrepresented in clinical trials.</p><p><strong>Objective: </strong>This study aimed to evaluate the safety and effectiveness of ocrelizumab in Hispanic/Latino people with multiple sclerosis (pwMS).</p><p><strong>Methods: </strong>Prospective longitudinal observational study including pwMS who received at least one dose of ocrelizumab between June 2018 and October 2023.</p><p><strong>Results: </strong>A total of 305 pwMS (223 relapsing-remitting MS (RRMS), 29 secondary progressive MS (SPMS), and 53 primary progressive MS (PPMS)), 67% female, mean age 38.7, mean disease duration 7 years, and median Expanded Disability Status Scale (EDSS) 2.0 (range 0-7). Median follow-up under ocrelizumab 29.5 (range 6-65) months. Only 1 patient had a relapse, 12-week-confirmed disability worsening was observed in 12.4% of the full cohort. Survival analysis showed higher risk of 12-week-confirmed disability worsening in SPMS compared with RRMS and PPMS (<i>p</i> = 0.0009). Magnetic resonance imaging (MRI) activity was significantly reduced from baseline across all disease phenotypes. Serious infections were observed in 4.6%, and two patients died during follow-up (one serious COVID-19 and one metastatic cancer). Notably, 22 pregnancies were reported, with 11 newborns and 6 pregnancies still on course.</p><p><strong>Conclusion: </strong>This study supports the effectiveness of ocrelizumab in a real-world cohort of individuals from traditionally underrepresented groups, such as the Latin American population, with a consistent safety profile in patients receiving care at a specialized MS Unit.</p>","PeriodicalId":18874,"journal":{"name":"Multiple Sclerosis Journal","volume":" ","pages":"13524585241309835"},"PeriodicalIF":4.8000,"publicationDate":"2025-01-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Multiple Sclerosis Journal","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1177/13524585241309835","RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"CLINICAL NEUROLOGY","Score":null,"Total":0}
引用次数: 0
Abstract
Background: Real-world studies are needed to expand our knowledge concerning populations underrepresented in clinical trials.
Objective: This study aimed to evaluate the safety and effectiveness of ocrelizumab in Hispanic/Latino people with multiple sclerosis (pwMS).
Methods: Prospective longitudinal observational study including pwMS who received at least one dose of ocrelizumab between June 2018 and October 2023.
Results: A total of 305 pwMS (223 relapsing-remitting MS (RRMS), 29 secondary progressive MS (SPMS), and 53 primary progressive MS (PPMS)), 67% female, mean age 38.7, mean disease duration 7 years, and median Expanded Disability Status Scale (EDSS) 2.0 (range 0-7). Median follow-up under ocrelizumab 29.5 (range 6-65) months. Only 1 patient had a relapse, 12-week-confirmed disability worsening was observed in 12.4% of the full cohort. Survival analysis showed higher risk of 12-week-confirmed disability worsening in SPMS compared with RRMS and PPMS (p = 0.0009). Magnetic resonance imaging (MRI) activity was significantly reduced from baseline across all disease phenotypes. Serious infections were observed in 4.6%, and two patients died during follow-up (one serious COVID-19 and one metastatic cancer). Notably, 22 pregnancies were reported, with 11 newborns and 6 pregnancies still on course.
Conclusion: This study supports the effectiveness of ocrelizumab in a real-world cohort of individuals from traditionally underrepresented groups, such as the Latin American population, with a consistent safety profile in patients receiving care at a specialized MS Unit.
期刊介绍：
Multiple Sclerosis Journal is a peer-reviewed international journal that focuses on all aspects of multiple sclerosis, neuromyelitis optica and other related autoimmune diseases of the central nervous system.
The journal for your research in the following areas:
* __Biologic basis:__ pathology, myelin biology, pathophysiology of the blood/brain barrier, axo-glial pathobiology, remyelination, virology and microbiome, immunology, proteomics
* __Epidemology and genetics:__ genetics epigenetics, epidemiology
* __Clinical and Neuroimaging:__ clinical neurology, biomarkers, neuroimaging and clinical outcome measures
* __Therapeutics and rehabilitation:__ therapeutics, rehabilitation, psychology, neuroplasticity, neuroprotection, and systematic management
Print ISSN: 1352-4585
求助内容：
应助结果提醒方式：
京公网安备 11010802042870号
