Abstract General Information
REal-world effectiveness and safety of nataLIzumab in relApsing-remittiNg multiple sClerosis Brazilian patiEnts – RELIANCE study
Introduction: There is a growing trend in the MS community that treating patients with high efficacy therapies (HET), such as Natalizumab (NTZ), will contribute to delay the disease activity and progression in patients with rapidly evolving, high activity disease or failure to other therapies (1).
Objectives: Evaluate the effectiveness of NTZ in the treatment of relapsing-remitting MS (RRMS).
Methods: Retrospective, observational, descriptive study conducted in Brazil with RRMS patients aged ≥ 18 years who received at least one year of continuous treatment with NTZ from January 1, 2013, to December 31, 2018. Medical chart review was performed to collect patients’ demographic, clinical and treatment patterns data.
Results: 166 RRMS patients were included in the study. Most used DMTs before switch to NTZ were Interferon β-1a (32%), Glatiramer acetate (28%), Interferon β-1b (21.3%), and Fingolimod (16%). Switch to NTZ was mainly due to therapeutic failure. Most patients switched after failure to the first line treatment, which is in line with the current recommendation to treat MS patients as early as possible with a HET (1).The overall median duration of NTZ treatment was 36 months (IQR 27-56) and Extended Interval Dosing (EID) occurred in 22.2% of patients, mainly to reduce the risk of progressive multifocal leukoencephalopathy (PML) in JCV+ patients (81%) while maintaining efficacy, as recommended by previous studies (2,3). The Annualized Relapse Rate (ARR) of RRMS patients 1 year before NTZ initiation was 0.67 while 1-year and 2-years after NTZ was 0.09, indicating the fast onset to control disease activity and the long-term effectiveness in reducing relapses over time.
Conclusion: Most patients who switched to NTZ were due to first-line treatment failure, suggesting a trend amongst Brazilian neurologists to treat early with HETs. The ARR observed indicates short- and long-term effectiveness of NTZ in a Real-World study.
Maria Fernanda Mendes, Elisa Matias Melo, Ivone Regina Fernandes, Alfredo Damasceno, Mariana Moreira Soares de Sá, Enedina Maria Oliveira, Alexandre Bussinger Lopes, Ana Claudia Piccolo, Ana Carolina Amaral Andrade, Bianca Etelvina Santos Oliveira, Jefferson Becker, Lucas Immich Gonçalves, Ronaldo Maciel Dias, Rafaela Ferreira, Isabella Zuppo, Charles Parolin, Maria Carolina Aquino Luque, Bruna Antinori Fonseca, Marcelo Ismael Paiva Castro, Rogerio Silva Rosada