دورية أكاديمية
Real-World Effectiveness and Safety of Cladribine in Multiple Sclerosis: Longitudinal Data From the Nationwide Registry in Argentina.
| العنوان: | Real-World Effectiveness and Safety of Cladribine in Multiple Sclerosis: Longitudinal Data From the Nationwide Registry in Argentina. |
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| المؤلفون: | Rojas JI, Alonso R, Luetic G; Instituto de Neurociencias de Rosario, Rosario, Argentina., Patrucco L; Centro de esclerosis múltiple de Buenos Aires, CABA, Argentina., Casas M; Centro Universitario de Esclerosis Múltiple - Hospital Dr. J. M. Ramos Mejía, Facultad de Medicina - UBA, CABA, Argentina., Silva B, Miguez J; Servicio de Neurología, Hospital Italiano de Buenos Aires, Buenos Aires, Argentina., Deri N; Centro de Investigaciones Diabaid, CABA, Argentina., Vrech C; Departamento de Enfermedades desmielinizantes - Sanatorio Allende, Córdoba., Liwacki S, Piedrabuena R, Silva E; Predigma - Centro de Medicina Preventiva, Posadas, Misiones, Argentina., Tkachuk V; Sección de Neuroinmunología y Enfermedades Desmielinizantes, Servicio de Neurología - Hospital de Clínicas José de San Martín, CABA, Argentina., Burgos M; Servicio de Neurología - Hospital San Bernardo, Salta, Argentina., Tavolini D; INECO Neurociencias Oroño - Fundación INECO, Rosario, Santa Fe, Argentina., Zanga G; Unidad asistencial César Milstein, CABA, Argentina., Pinheiro AA; Hospital San Martín, Paraná, Entre Ríos, Argentina., Hryb J; Servicio de Neurología - Hospital Carlos G. Durand, CABA, Argentina., Leguizamon F; Hospital de Agudos, Dr. Teodoro Álvarez, CABA, Argentina., Knorre E; Hospital de Agudos, Dr. Teodoro Álvarez, CABA, Argentina., Lopez PA; Neuroimmunology Unit, Department of Neuroscience, Hospital Aleman, Buenos Aires, Argentina., Martinez A; Sección de Enfermedades Desmielinizantes - Hospital Británico, CABA, Argentina., Carrá A; Sección de Enfermedades Desmielinizantes - Hospital Británico, CABA, Argentina., Alonso Serena M; Servicio de clínica médica, Hospital Italiano de Buenos Aires, CABA, Argentina., Cristiano E; Centro de esclerosis múltiple de Buenos Aires, CABA, Argentina., Correale J; Departamento de Neurología - FLENI, CABA, Argentina., Garcea O; Centro Universitario de Esclerosis Múltiple - Hospital Dr. J. M. Ramos Mejía, Facultad de Medicina - UBA, CABA, Argentina., Fernandez Liguori N, Carnero Contentti E; Neuroimmunology Unit, Department of Neuroscience, Hospital Aleman, Buenos Aires, Argentina. |
| المصدر: | Clinical neuropharmacology [Clin Neuropharmacol] 2024 Jul-Aug 01; Vol. 47 (4), pp. 120-127. Date of Electronic Publication: 2024 May 22. |
| نوع المنشور: | Journal Article; Multicenter Study |
| اللغة: | English |
| بيانات الدورية: | Publisher: Lippincott Williams & Wilkins Country of Publication: United States NLM ID: 7607910 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1537-162X (Electronic) Linking ISSN: 03625664 NLM ISO Abbreviation: Clin Neuropharmacol Subsets: MEDLINE |
| أسماء مطبوعة: | Publication: Hagerstown, MD : Lippincott Williams & Wilkins Original Publication: New York, Raven Press. |
| مواضيع طبية MeSH: | Cladribine*/therapeutic use , Cladribine*/adverse effects , Immunosuppressive Agents*/therapeutic use , Immunosuppressive Agents*/adverse effects , Registries*, Humans ; Argentina/epidemiology ; Female ; Male ; Adult ; Longitudinal Studies ; Middle Aged ; Multiple Sclerosis, Relapsing-Remitting/drug therapy ; Multiple Sclerosis, Relapsing-Remitting/epidemiology ; Treatment Outcome ; Lymphopenia/chemically induced ; Lymphopenia/epidemiology ; Young Adult |
| مستخلص: | 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. (Copyright © 2024 Wolters Kluwer Health, Inc. All rights reserved.) |
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| معلومات مُعتمدة: | F31 CA196216 United States CA NCI NIH HHS |
| المشرفين على المادة: | 47M74X9YT5 (Cladribine) 0 (Immunosuppressive Agents) |
| تواريخ الأحداث: | Date Created: 20240715 Date Completed: 20240715 Latest Revision: 20240731 |
| رمز التحديث: | 20240731 |
| مُعرف محوري في PubMed: | PMC11287052 |
| DOI: | 10.1097/WNF.0000000000000598 |
| PMID: | 39008542 |
| قاعدة البيانات: | MEDLINE |
Full Text Finder | تدمد: | 1537-162X |
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| DOI: | 10.1097/WNF.0000000000000598 |