Damiano Baroncini1, Angelo Ghezzi2, Pietro O Annovazzi2, Bruno Colombo3, Vittorio Martinelli3, Giorgio Minonzio4, Lucia Moiola3, Mariaemma Rodegher3, Mauro Zaffaroni2, Giancarlo Comi5. 1. Multiple Sclerosis Study Center, Sant'Antonio Abate Hospital, Gallarate, Italy damianobaroncini@gmail.com. 2. Multiple Sclerosis Study Center, Sant'Antonio Abate Hospital, Gallarate, Italy. 3. Department of Neurology, San Raffaele Hospital, Milan, Italy. 4. Department of Neuroradiology, Sant'Antonio Abate Hospital, Gallarate, Italy. 5. Department of Neurology, San Raffaele Hospital, Milan, Italy/Division of Neuroscience, Department of Neurology, Institute of Experimental Neurology, San Raffaele Scientific Institute, Milan, Italy.
Abstract
BACKGROUND: Natalizumab and fingolimod have not been compared in controlled trials but only in observational studies, with inconclusive results. OBJECTIVES: The objective of this study is to compare the effect of natalizumab and fingolimod in reducing disease activity in relapsing-remitting multiple sclerosis (RRMS). METHODS: We included all consecutive RRMS patients switched from first-line agents (glatiramer acetate/interferons) to natalizumab or fingolimod, with a follow-up of 24 months. Data of relapses, Expanded Disability Status Scale score and brain magnetic resonance imaging (MRI) scans were collected. We used propensity score (PS) matching and intention-to-treat analysis. RESULTS: We retained 102 patients in each cohort after PS matching, with similar baseline characteristics. More patients discontinued natalizumab compared to fingolimod (33% vs 11%, p < 0.001), mainly for progressive multifocal leukoencephalopathy (PML) concern. No serious adverse events occurred in the two cohorts. Compared to fingolimod, the natalizumab group presented a higher percentage of relapse-free patients (66% vs 80%, p = 0.015), a higher percentage of disability-improved patients (6% vs 15%, p = 0.033), a lower percentage of MRI-active patients (38% vs 14%, p = 0.001) and a higher percentage of patients with no evidence of disease activity (NEDA-3; 44% vs 70%, p < 0.001) after 2 years of follow-up. Disability worsening was not statistically different in the two groups. CONCLUSION: Natalizumab is superior to fingolimod in RRMS patients non-responding to first-line agents.
BACKGROUND:Natalizumab and fingolimod have not been compared in controlled trials but only in observational studies, with inconclusive results. OBJECTIVES: The objective of this study is to compare the effect of natalizumab and fingolimod in reducing disease activity in relapsing-remitting multiple sclerosis (RRMS). METHODS: We included all consecutive RRMS patients switched from first-line agents (glatiramer acetate/interferons) to natalizumab or fingolimod, with a follow-up of 24 months. Data of relapses, Expanded Disability Status Scale score and brain magnetic resonance imaging (MRI) scans were collected. We used propensity score (PS) matching and intention-to-treat analysis. RESULTS: We retained 102 patients in each cohort after PS matching, with similar baseline characteristics. More patients discontinued natalizumab compared to fingolimod (33% vs 11%, p < 0.001), mainly for progressive multifocal leukoencephalopathy (PML) concern. No serious adverse events occurred in the two cohorts. Compared to fingolimod, the natalizumab group presented a higher percentage of relapse-free patients (66% vs 80%, p = 0.015), a higher percentage of disability-improved patients (6% vs 15%, p = 0.033), a lower percentage of MRI-active patients (38% vs 14%, p = 0.001) and a higher percentage of patients with no evidence of disease activity (NEDA-3; 44% vs 70%, p < 0.001) after 2 years of follow-up. Disability worsening was not statistically different in the two groups. CONCLUSION:Natalizumab is superior to fingolimod in RRMS patients non-responding to first-line agents.
Authors: Maria Trojano; Mar Tintore; Xavier Montalban; Jan Hillert; Tomas Kalincik; Pietro Iaffaldano; Tim Spelman; Maria Pia Sormani; Helmut Butzkueven Journal: Nat Rev Neurol Date: 2017-01-13 Impact factor: 42.937
Authors: Jonathan Alsop; Jennie Medin; Christian Cornelissen; Stefan Viktor Vormfelde; Tjalf Ziemssen Journal: PLoS One Date: 2017-05-05 Impact factor: 3.240