Juan Ignacio Rojas, Ricardo Alonso, Geraldine Luetic, Liliana Patrucco, Magdalena Casas, Berenice Silva, Jimena Miguez, Norma Deri, Carlos Vrech, Susana Liwacki, Raúl Piedrabuena, Emanuel Silva, Verónica Tkachuk, Marcos Burgos, Dario Tavolini, Gisela Zanga, Amelia Alvez Pinheiro, Javier Hryb, Felisa Leguizamon, Eduardo Knorre, Pablo A Lopez, Alejandra Martinez, Adriana Carrá, Marina Alonso Serena, Edgardo Cristiano, Jorge Correale, Orlando Garcea, Nora Fernandez Liguori, Edgar Carnero Contentti
{"title":"克拉利宾治疗多发性硬化症的实际效果和安全性：阿根廷全国登记处的纵向数据。","authors":"Juan Ignacio Rojas, Ricardo Alonso, Geraldine Luetic, Liliana Patrucco, Magdalena Casas, Berenice Silva, Jimena Miguez, Norma Deri, Carlos Vrech, Susana Liwacki, Raúl Piedrabuena, Emanuel Silva, Verónica Tkachuk, Marcos Burgos, Dario Tavolini, Gisela Zanga, Amelia Alvez Pinheiro, Javier Hryb, Felisa Leguizamon, Eduardo Knorre, Pablo A Lopez, Alejandra Martinez, Adriana Carrá, Marina Alonso Serena, Edgardo Cristiano, Jorge Correale, Orlando Garcea, Nora Fernandez Liguori, Edgar Carnero Contentti","doi":"10.1097/WNF.0000000000000598","DOIUrl":null,"url":null,"abstract":"<p><strong>Objective: </strong>The aim was to evaluate patient profiles, effectiveness and safety of cladribine (CLAD) in patients with relapsing-remitting multiple sclerosis in Argentina.</p><p><strong>Methods: </strong>This was a substudy included in RelevarEM (MS and neuromyelitis optica registry in Argentina, NCT03375177). Patients with MS who received CLAD tablets and were followed up for at least 24 months were included. Clinical evaluations every 3 months collect information about: a) clinical relapses; b) progression of physical disability, evaluated through Expanded Disability Status Scale, and c) new lesions found in the magnetic resonance imaging. Lymphopenia was evaluated during the follow-up and defined as grade 1: absolute lymphocyte count (ALC) 800-999/μL; grade 2: ALC 500-799/μL; grade 3: ALC 200-499/μL and grade 4: ALC <200/μL.</p><p><strong>Results: </strong>A total of 240 patients were included from 19 centers from Argentina. The mean annualized relapse rate during the 12-month pre-CLAD initiation was 1.19 ± 0.56 versus 0.22 ± 0.18 at month 12 and 0.19 ± 0.15 at month 24 (P < 0.001). A total of 142 (59.2%) fulfilled the criteria of disease activity during the 12 months before treatment initiation, whereas 27 (11.3%) fulfilled it at month 12 and 38 (15.8%) at month 24, P < 0.001. Regarding no evidence of disease activity (NEDA), 202 (84.2%) patients achieved NEDA status at month 12 and 185 (77%) at month 24. The most frequent incidence density of lymphopenia for course 2 observed was also for grade 1, 6.1 (95% confidence interval [CI] = 5.5-7.1). The overall incidence density of lymphopenia grade 4 was 0.1 (95% CI = 0.06-0.19).</p><p><strong>Conclusion: </strong>This information will help when choosing the best treatment option for Argentinean patients.</p>","PeriodicalId":10449,"journal":{"name":"Clinical Neuropharmacology","volume":" ","pages":""},"PeriodicalIF":0.8000,"publicationDate":"2024-05-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Real-World Effectiveness and Safety of Cladribine in Multiple Sclerosis: Longitudinal Data From the Nationwide Registry in Argentina.\",\"authors\":\"Juan Ignacio Rojas, Ricardo Alonso, Geraldine Luetic, Liliana Patrucco, Magdalena Casas, Berenice Silva, Jimena Miguez, Norma Deri, Carlos Vrech, Susana Liwacki, Raúl Piedrabuena, Emanuel Silva, Verónica Tkachuk, Marcos Burgos, Dario Tavolini, Gisela Zanga, Amelia Alvez Pinheiro, Javier Hryb, Felisa Leguizamon, Eduardo Knorre, Pablo A Lopez, Alejandra Martinez, Adriana Carrá, Marina Alonso Serena, Edgardo Cristiano, Jorge Correale, Orlando Garcea, Nora Fernandez Liguori, Edgar Carnero Contentti\",\"doi\":\"10.1097/WNF.0000000000000598\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Objective: </strong>The aim was to evaluate patient profiles, effectiveness and safety of cladribine (CLAD) in patients with relapsing-remitting multiple sclerosis in Argentina.</p><p><strong>Methods: </strong>This was a substudy included in RelevarEM (MS and neuromyelitis optica registry in Argentina, NCT03375177). Patients with MS who received CLAD tablets and were followed up for at least 24 months were included. Clinical evaluations every 3 months collect information about: a) clinical relapses; b) progression of physical disability, evaluated through Expanded Disability Status Scale, and c) new lesions found in the magnetic resonance imaging. Lymphopenia was evaluated during the follow-up and defined as grade 1: absolute lymphocyte count (ALC) 800-999/μL; grade 2: ALC 500-799/μL; grade 3: ALC 200-499/μL and grade 4: ALC <200/μL.</p><p><strong>Results: </strong>A total of 240 patients were included from 19 centers from Argentina. The mean annualized relapse rate during the 12-month pre-CLAD initiation was 1.19 ± 0.56 versus 0.22 ± 0.18 at month 12 and 0.19 ± 0.15 at month 24 (P < 0.001). A total of 142 (59.2%) fulfilled the criteria of disease activity during the 12 months before treatment initiation, whereas 27 (11.3%) fulfilled it at month 12 and 38 (15.8%) at month 24, P < 0.001. Regarding no evidence of disease activity (NEDA), 202 (84.2%) patients achieved NEDA status at month 12 and 185 (77%) at month 24. The most frequent incidence density of lymphopenia for course 2 observed was also for grade 1, 6.1 (95% confidence interval [CI] = 5.5-7.1). The overall incidence density of lymphopenia grade 4 was 0.1 (95% CI = 0.06-0.19).</p><p><strong>Conclusion: </strong>This information will help when choosing the best treatment option for Argentinean patients.</p>\",\"PeriodicalId\":10449,\"journal\":{\"name\":\"Clinical Neuropharmacology\",\"volume\":\" \",\"pages\":\"\"},\"PeriodicalIF\":0.8000,\"publicationDate\":\"2024-05-23\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Clinical Neuropharmacology\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1097/WNF.0000000000000598\",\"RegionNum\":4,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q4\",\"JCRName\":\"CLINICAL NEUROLOGY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Clinical Neuropharmacology","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1097/WNF.0000000000000598","RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q4","JCRName":"CLINICAL NEUROLOGY","Score":null,"Total":0}
Real-World Effectiveness and Safety of Cladribine in Multiple Sclerosis: Longitudinal Data From the Nationwide Registry in Argentina.
Objective: The aim was to evaluate patient profiles, effectiveness and safety of cladribine (CLAD) in patients with relapsing-remitting multiple sclerosis in Argentina.
Methods: This was a substudy included in RelevarEM (MS and neuromyelitis optica registry in Argentina, NCT03375177). Patients with MS who received CLAD tablets and were followed up for at least 24 months were included. Clinical evaluations every 3 months collect information about: a) clinical relapses; b) progression of physical disability, evaluated through Expanded Disability Status Scale, and c) new lesions found in the magnetic resonance imaging. Lymphopenia was evaluated during the follow-up and defined as grade 1: absolute lymphocyte count (ALC) 800-999/μL; grade 2: ALC 500-799/μL; grade 3: ALC 200-499/μL and grade 4: ALC <200/μL.
Results: A total of 240 patients were included from 19 centers from Argentina. The mean annualized relapse rate during the 12-month pre-CLAD initiation was 1.19 ± 0.56 versus 0.22 ± 0.18 at month 12 and 0.19 ± 0.15 at month 24 (P < 0.001). A total of 142 (59.2%) fulfilled the criteria of disease activity during the 12 months before treatment initiation, whereas 27 (11.3%) fulfilled it at month 12 and 38 (15.8%) at month 24, P < 0.001. Regarding no evidence of disease activity (NEDA), 202 (84.2%) patients achieved NEDA status at month 12 and 185 (77%) at month 24. The most frequent incidence density of lymphopenia for course 2 observed was also for grade 1, 6.1 (95% confidence interval [CI] = 5.5-7.1). The overall incidence density of lymphopenia grade 4 was 0.1 (95% CI = 0.06-0.19).
Conclusion: This information will help when choosing the best treatment option for Argentinean patients.
期刊介绍：
Clinical Neuropharmacology is a peer-reviewed journal devoted to the pharmacology of the nervous system in its broadest sense. Coverage ranges from such basic aspects as mechanisms of action, structure-activity relationships, and drug metabolism and pharmacokinetics, to practical clinical problems such as drug interactions, drug toxicity, and therapy for specific syndromes and symptoms. The journal publishes original articles and brief reports, invited and submitted reviews, and letters to the editor. A regular feature is the Patient Management Series: in-depth case presentations with clinical questions and answers.
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