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Multicenter Study
. 2021 Apr;79(4):305-309.
doi: 10.1590/0004-282X-ANP-2020-0339.

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

Juan Ignacio Rojas  1   2 , Liliana Patrucco  2   3 , Manuel Fruns  4 , Giesela Hornung  4 , José Flores  5   6 , Edgar Carnero Contentti  7 , Pablo Adrian Lopez  7 , Juan Pablo Pettinicchi  7 , Alejandro Caride  7 , Lorna Galleguillos  8 , Jorge Barahona  8 , Violeta Diaz  8 , Marianella Hernández  8 , Ricardo Alonso  9   10 , Edgardo Cristiano  2
Affiliations
Multicenter Study

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

Juan Ignacio Rojas et al. Arq Neuropsiquiatr. 2021 Apr.

Abstract
in English, Spanish

Background: Despite the abundance of information concerning ocrelizumab in phase III clinical trials, there is scarce evidence regarding real-world patient profiles.

Objective: 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.

Methods: 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.

Results: 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.

Conclusions: 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.

Introducción:: A pesar de la abundante información sobre ocrelizumab proveniente de los ensayos clínicos de fase III, todavía se tiene poca evidencia sobre la efectividad y el perfil de pacientes provenientes de la vida real.

Objetivo:: Evaluar el perfil clínico y demográfico, la efectividad y la persistencia al tratamiento en pacientes que usaron el ocrelizumab para el tratamiento de esclerosis múltiple (EM) en Latinoamérica.

Métodos:: Estudio retrospectivo multicéntrico en Argentina, Chile y México. Se analizaron los datos de los pacientes que recibieron ocrelizumab. Se describieron las variables demográficas y clínicas, así como los resultados de efectividad que incluyeron la proporción de pacientes libres de recaídas clínicas, libres de progresión de la discapacidad, libres de nuevas lesiones en la secuencia T2 o T1 con gadolinio durante el seguimiento.

Resultados:: Se incluyeron 81 pacientes. El fenotipo más frecuente fue EM remitente recurrente (EMRR) en el 64,2% de los pacientes. La edad media fue de 41.3±12 años, y el 51,8% eran mujeres. Un total de 38% tuvo recaídas durante los 12 meses previos al inicio de ocrelizumab, con una tasa anualizada de recaídas media de 1.3±0.6 durante ese período. En el seguimiento a 12 meses, el 75% estuvo libre de recaídas clínicas y el 91%, libre de nuevas lesiones en RM. Tres pacientes interrumpieron el tratamiento durante el seguimiento (3,7%). La persistencia al tratamiento observada durante el primer año de seguimiento fue de 338±24 días.

Conclusión:: Nuestro estudio está en línea con los datos provenientes de ensayos clínicos aleatorizados previos y estudios recientes del mundo real que describen la efectividad de los perfiles de pacientes y la persistencia al tratamiento con ocrelizumab en pacientes con EM en Latinoamérica.

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Conflict of interest statement

Conflicts of interest: EC: has received fees for consultations as a scientific advisory board member and for travel to meetings, conferences and clinical trials of the following companies: Avanir, Bayer, Biogen, Merck, Novartis, Roche and Teva; JIR: has received honoraria from Novartis as a scientific advisor. He has received travel grants and attended courses and conferences on behalf of Merck-Serono Argentina and Novartis Argentina; LP: has received honoraria for scientific and research grants from Teva Tuteur, Merck Serono, Biogen Idec and Bayer Schering; ECC: has received personal compensation for consulting, serving on a scientific advisory board, speaking or other activities with Biogen-Idec, Genzyme, Merck-Serono, Novartis, Teva, Roche and Bayer; PAL: has received personal compensation for consulting, serving on a scientific advisory board, speaking or other activities with Biogen-Idec, Genzyme, Merck-Serono, Novartis, Teva, Roche and Bayer; JPP: has received personal compensation for consulting, serving on a scientific advisory board, speaking or other activities with Biogen-Idec, Genzyme, Merck-Serono, Novartis, Teva, Roche and Bayer; AC: has received personal compensation for consulting, serving on a scientific advisory board, speaking or other activities with Biogen-Idec, Genzyme, Merck-Serono, Novartis, Teva, Roche and Bayer; RA: has received personal compensation for consulting, serving on a scientific advisory board, speaking or other activities from Biogen, Merck Serono, Novartis, Sanofi-Genzyme and Roche; MF: has received personal compensation for consulting, serving on a scientific advisory board, speaking or other activities from Biogen, Merck, Novartis and Roche; GH: has received personal compensation for consulting, serving on a scientific advisory board, speaking or other activities from Biogen, Merck, Novartis and Roche; JF, LG, JB, VD and MH: have nothing to disclose.

Figures

Figure 1.
Figure 1.. Persistence with ocrelizumab treatment during the study period.
See this image and copyright information in PMC

References

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