Real-world experience of ocrelizumab in multiple sclerosis patients in Latin America.

Juan Ignacio Rojas,Edgar Carnero Contentti,Edgardo Cristiano,Lorna Galleguillos,Pablo Adrian Lopez,Alejandro Caride,Ricardo Alonso,Jorge Barahona,Marianella Hernández,Giesela Hornung,Manuel Fruns,Liliana Patrucco,Juan Pablo Pettinicchi,Violeta Diaz,José Flores

doi:10.1590/0004-282x-anp-2020-0339

Abstract

Despite the abundance of information concerning ocrelizumab in phase III clinical trials, there is scarce evidence regarding real-world patient profiles. The aim of this study was to investigate patient profiles, effectiveness and persistence with treatment among patients who used ocrelizumab for treatment of multiple sclerosis in Latin America. This was a retrospective multicenter study in Argentina, Chile and Mexico. Medical record databases on patients who received ocrelizumab were analyzed. Demographic and clinical variables were described, along with effectiveness outcomes, which included the proportions of patients free from clinical relapses, from disability progression and from new or enlarging T2 or T1 gadolinium-enhancing lesions, on annual magnetic resonance imaging. A total of 81 patients were included. The most frequent phenotype was relapsing-remitting MS, in 64.2% of the patients. The mean age at study entry was 41.3 ± 12.0 years and 51.8% were women. A total of 38% had had relapse activity during the 12 months before starting on ocrelizumab, with a mean relapse rate of 1.3 ± 0.6 during that period. 75% were free from clinical relapses and 91% were free from gadolinium-enhancing lesions in the relapsing-remitting course. Ocrelizumab discontinuation during the first 12 months was observed in three patients (3.7%). The mean persistence observed during the first-year follow-up was 338 ± 24 days. Our study is in line with previous randomized clinical trials and recent real-world studies describing patient profiles, effectiveness and persistence regarding ocrelizumab treatment in multiple sclerosis patients in Latin America.

Highlights

Multiple sclerosis (MS) is a chronic inflammatory disease of the CNS that leads to focal plaques of primary demyelination and diffuse neurodegeneration in the grey and white matter of the brain and spinal cord[1]
To consider a case to be one of progression, if there had been a clinical relapse, the patient needed to be 3 months away from the relapse, regardless of whether steroid treatment had been received for management of the acute episode. c) New lesions found on magnetic resonance imaging (MRI)
EDSS progression was observed in 49.4% of patients during the previous 12 months, while new T2 MRI lesions were described in 68% of the patients

Summary

Introduction

Multiple sclerosis (MS) is a chronic inflammatory disease of the CNS that leads to focal plaques of primary demyelination and diffuse neurodegeneration in the grey and white matter of the brain and spinal cord[1]. The disease starts with a relapsing-remitting course (RRMS), which is followed for several years by a secondary progressive phase (SPMS). Patients with primary progressive disease (PPMS) skip the relapsing and remitting stage and start with uninterrupted progression from disease onset[2]. It has been almost 25 years since the publication of the pivotal trial results for the first disease-modifying therapy (DMT) for RRMS3. Despite the abundance of information concerning the efficacy and safety of ocrelizumab in phase III clinical trials, there is scarce evidence regarding realworld patient profiles. Despite the abundance of information concerning ocrelizumab in phase III clinical trials, there is scarce evidence regarding real-world patient profiles.

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Conclusion