ECTRIMS eLearning

Long-term effect of natalizumab in a French cohort of patients with RRMS: TYSTEN cohort
Author(s): ,
K. Bigaut
Affiliations:
Department of Neurology, Hôpitaux Universitaires de Strasbourg
,
T. Fabacher
Affiliations:
Groupe Méthode en Recherche Clinique, Hôpitaux Universitaires de Strasbourg, Strasbourg, France
,
N. Collongues
Affiliations:
Department of Neurology, Hôpitaux Universitaires de Strasbourg
,
L. Kremer
Affiliations:
Department of Neurology, Hôpitaux Universitaires de Strasbourg
,
M.-C. Fleury
Affiliations:
Department of Neurology, Hôpitaux Universitaires de Strasbourg
,
J.-C. Ongagna
Affiliations:
Department of Neurology, Hôpitaux Universitaires de Strasbourg
J. De Seze
Affiliations:
Department of Neurology, Hôpitaux Universitaires de Strasbourg
ECTRIMS Learn. Bigaut K. 10/10/18; 229463; EP1626
Kevin Bigaut
Kevin Bigaut
Contributions
Abstract

Abstract: EP1626

Type: Poster Sessions

Abstract Category: Therapy - Long-term treatment monitoring

Introduction: Long-term evolution of multiple sclerosis (MS) has been studied in several cohorts without treatment or on immunomodulatory drugs. However, long-term follow-up on new generation drugs is missing. Natalizumab (NTZ) is among the most effective treatment in relapsing-remitting multiple sclerosis (RRMS) but it remains unclear if NTZ improves the long-term course.
Objective: To describe the long-term effect of NTZ on patients with a RRMS and to investigate potential predictive factors on long-term outcomes.
Methods: Patients starting between April 2007 and April 2012 in Alsace region in France were included and followed to April 2017. Data were used to estimate the median time until secondary progressive multiple sclerosis (SPMS) conversion and reaching Expanded Disability Status Scale (EDSS) score 6.0 using Kaplan-Meier method. Hazard ratio (HR) were defined by Cox model.
Results: 325 patients were included after a mean disease duration of 8.7 years. The mean follow-up was 83 months and 59 months on NTZ. The annualized relapse rate decreased by 79.5% and 41.9% of patients had no evidence of disease at 2 years. The median time until SPMS conversion and reaching EDSS 6.0 were 26 years and 34 years respectively. For SPMS, predictive factors were initial EDSS (HR=1.56, 95%CI: 1.33-1.84, p< 0.0001), MS duration before NTZ (HR=1.04, 95%CI: 1.01-1.08, p=0.03), MRI worsening at 2 years (HR=1.86, 95%CI: 1.05-3.31, p=0.03) and medication possession ratio of NTZ (MPR; HR=0.99, 95%CI: 0.98-0.99, p=0.03). For EDSS 6.0, predictive factors were initial EDSS (HR=2.68, 95%CI: 1.94-3.71, p< 0.0001), EDSS worsening at 2 years (HR=3.94, 95%CI: 1.92-8.09, p=0.0002) and MPR (HR=0.98, 95%CI: 0.97-0.99, p=0.0007).
Conclusion: Compared to previous studies without treatment, NTZ seems to delay the progressive phase and high disability. Some predictive factors could be an assistance in the therapeutic decision making. These results need to be confirmed in larger and longer studies.
Disclosure: Kevin Bigaut: nothing to disclose.
Thibaut Fabacher: nothing to disclose.
Nicolas Collongues has received fees as a consultant or for presentations in partnership with Biogen Idec.
Laurent Kremer has received fees for presentations in partnership with Biogen Idec.
Marie-Celine Fleury: nothing to disclose.
Jean-Claude Ongagna: nothing to disclose.
Jerome De Seze has received fees as a consultant or for presentations in partnership with Biogen Idec.

Abstract: EP1626

Type: Poster Sessions

Abstract Category: Therapy - Long-term treatment monitoring

Introduction: Long-term evolution of multiple sclerosis (MS) has been studied in several cohorts without treatment or on immunomodulatory drugs. However, long-term follow-up on new generation drugs is missing. Natalizumab (NTZ) is among the most effective treatment in relapsing-remitting multiple sclerosis (RRMS) but it remains unclear if NTZ improves the long-term course.
Objective: To describe the long-term effect of NTZ on patients with a RRMS and to investigate potential predictive factors on long-term outcomes.
Methods: Patients starting between April 2007 and April 2012 in Alsace region in France were included and followed to April 2017. Data were used to estimate the median time until secondary progressive multiple sclerosis (SPMS) conversion and reaching Expanded Disability Status Scale (EDSS) score 6.0 using Kaplan-Meier method. Hazard ratio (HR) were defined by Cox model.
Results: 325 patients were included after a mean disease duration of 8.7 years. The mean follow-up was 83 months and 59 months on NTZ. The annualized relapse rate decreased by 79.5% and 41.9% of patients had no evidence of disease at 2 years. The median time until SPMS conversion and reaching EDSS 6.0 were 26 years and 34 years respectively. For SPMS, predictive factors were initial EDSS (HR=1.56, 95%CI: 1.33-1.84, p< 0.0001), MS duration before NTZ (HR=1.04, 95%CI: 1.01-1.08, p=0.03), MRI worsening at 2 years (HR=1.86, 95%CI: 1.05-3.31, p=0.03) and medication possession ratio of NTZ (MPR; HR=0.99, 95%CI: 0.98-0.99, p=0.03). For EDSS 6.0, predictive factors were initial EDSS (HR=2.68, 95%CI: 1.94-3.71, p< 0.0001), EDSS worsening at 2 years (HR=3.94, 95%CI: 1.92-8.09, p=0.0002) and MPR (HR=0.98, 95%CI: 0.97-0.99, p=0.0007).
Conclusion: Compared to previous studies without treatment, NTZ seems to delay the progressive phase and high disability. Some predictive factors could be an assistance in the therapeutic decision making. These results need to be confirmed in larger and longer studies.
Disclosure: Kevin Bigaut: nothing to disclose.
Thibaut Fabacher: nothing to disclose.
Nicolas Collongues has received fees as a consultant or for presentations in partnership with Biogen Idec.
Laurent Kremer has received fees for presentations in partnership with Biogen Idec.
Marie-Celine Fleury: nothing to disclose.
Jean-Claude Ongagna: nothing to disclose.
Jerome De Seze has received fees as a consultant or for presentations in partnership with Biogen Idec.

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