Download PDF
Open Access
CC BY 4.0 · Arq Neuropsiquiatr 2024; 82(S 01): S1-S52
DOI: 10.1055/s-0044-1789396
Supplement

Real-world study of oral cladribine for Brazilian patients with multiple sclerosis: results from the BRANDO registry

Authors

  • Mateus Boaventura de Oliveira

    1   Universidade de São Paulo, Faculdade de Medicina, Hospital das Clínicas, São Paulo SP, Brazil.

  • Jefferson Becker

    3   Pontifícia Universidade Católica do Rio Grande do Sul, Hospital São Lucas, Porto Alegre RS, Brazil.

  • Carlos Bernardo Tauil

    4   Universidade de Brasília, Brasília DF, Brazil.

  • Laura Fiuza Parolin

    5   Neurovie, Departamento de Neurologia, Joinville SC, Brazil.

  • Samira Luisa Apóstolos-Pereira

    1   Universidade de São Paulo, Faculdade de Medicina, Hospital das Clínicas, São Paulo SP, Brazil.

  • Alfredo Damasceno

    6   Universidade Estadual de Campinas, Campinas SP, Brazil.

  • Thiago Gonçalves Fukuda

    7   Universidade Federal da Bahia, Hospital Universitário Professor Edgar Santos, Salvador BA, Brazil.

  • Maria Fernanda Mendes

    8   Santa Casa de São Paulo, Faculdade de Ciências Médicas, São Paulo SP, Brazil.

  • Gabriela Martins

    9   Hospital Geral de Fortaleza, Departamento de Neuroimunologia, Fortaleza CE, Brazil.

  • Denise Sisterolli Diniz

    10   Universidade Federal de Goiás, Goiânia GO, Brazil.

  • Henry Koiti

    11   Instituto Neurológico de Curitiba, Curitiba PR, Brazil.

  • Herval Neto

    12   Hospital do Servidor Público Estadual de São Paulo, São Paulo SP, Brazil.

  • Paulo Diniz da Gama

    13   Pontifícia Universidade Católica de São Paulo, Sorocaba SP, Brazil.

  • Giordani Rodrigues dos Passos

    14   Secretaria de Saúde do Distrito Federal, Brasília DF, Brazil.

  • Kleber Cavalcante dos Santos

    5   Neurovie, Departamento de Neurologia, Joinville SC, Brazil.

  • Marcus Vinicius Magno Gonçalves

    6   Universidade Estadual de Campinas, Campinas SP, Brazil.

  • Mariana de Sá

    6   Universidade Estadual de Campinas, Campinas SP, Brazil.

  • Dagoberto Callegaro

    15   Universidade de São Paulo, Faculdade de Medicina, Hospital das Clínicas, Departamento de Neurologia, São Paulo SP, Brazil.
Further Information
Also available at
 
 PDF Download Permissions and Reprints

Address for correspondence: Mateus Boaventura de Oliveira (email: mateusboaventura@yahoo.com.br).

Abstract

Background: Treatment with oral cladribine was approved in Brazil in 2019; since then, it has been prescribed to different multiple sclerosis (MS) patient profiles, with no local real-world experience data.

Objective: To report the main reasons to initiate cladribine treatment in Brazil. To report the efficacy and persistence among Brazilian MS patients under cladribine treatment.

Methods: The present is an observational, retrospective, longitudinal study of cladribine-treated MS patients reported by neurologists in the Collaborative Latin American Database for Multiple Sclerosis (BRANDO) registry. The inclusion criteria were: age over 18 years, diagnosis of relapsing-onset MS according to current criteria, and initiation of oral cladribine at least 6 months before analysis. The core clinical data included disease activity (relapses and follow-up MRI) and worsening of the score on the Expanded Disability Status Scale (EDSS).

Results: We included 39 cladribine-treated patients in the baseline analysis, 29 (74.4%) of them female subjects. The median age at disease onset was of 24.9 (19.9–47.8) years, and at the start of the cladribine treatment, it was of 28.9 (19–49.5) years. The median baseline EDSS score was of 2.5 (0–6.0). The main reasons to prescribe cladribine were: previous treatment failure (8/25; 32%); naive patients (6/25; 24%); risk of development of progressive multifocal leukoencephalopathy (PML; 6/25; 24%); adverse event (1/25; 4%); and other reasons (4/25; 16%). After a median follow-up of 24.7 (6.0–43.4) months, 25/39 (64.1%) patients remained relapse-free, 25/27 (92.6%) were EDSS progression-free, 18/35 (51.4%) patients did not present MRI activity, and 8/26 (30.8%) patients were on NEDA-3. Concerning discontinuation, 7 (17.9%) patients switched to another treatment after cladribine. Lymphopenia of grades 3 or 4 occurred in 4/28 (14.3%) MS patients.

Conclusion: Our real-world observational data discloses a heterogenous profile of cladribine indication. We observed higher failure of treatment measures compared with pivotal trials, which may be related to the fewer naive patients in our sample. Larger sample sizes are needed to confirm our results, as well as to provide statistical power regarding which patient subgroups are at greatest risk of therapeutic failure.


No conflict of interest has been declared by the author(s).

Publication History

Article published online:
02 October 2024

© 2024. The Author(s). This is an open access article published by Thieme under the terms of the Creative Commons Attribution 4.0 International License, permitting copying and reproduction so long as the original work is given appropriate credit (https://creativecommons.org/licenses/by/4.0/)

Thieme Revinter Publicações Ltda.
Rua do Matoso 170, Rio de Janeiro, RJ, CEP 20270-135, Brazil

  Permissions and Reprints