학술논문
Real-World Effectiveness and Safety of Cladribine in Multiple Sclerosis: Longitudinal Data From the Nationwide Registry in Argentina
Document Type
Academic Journal
Author
Rojas, Juan Ignacio; Alonso, Ricardo; Luetic, Geraldine; Patrucco, Liliana; Casas, Magdalena; Silva, Berenice; Miguez, Jimena; Deri, Norma; Vrech, Carlos; Liwacki, Susana; Piedrabuena, Raúl; Silva, Emanuel; Tkachuk, Verónica; Burgos, Marcos; Tavolini, Dario; Zanga, Gisela; Pinheiro, Amelia Alvez; Hryb, Javier; Leguizamon, Felisa; Knorre, Eduardo; Lopez, Pablo A.; Martinez, Alejandra; Carrá, Adriana; Alonso Serena, Marina; Cristiano, Edgardo; Correale, Jorge; Garcea, Orlando; Fernandez Liguori, Nora; Carnero Contentti, Edgar
Source
Clinical Neuropharmacology. May 23, 2024
Subject
Language
English
ISSN
0362-5664
Abstract
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.