Kévin Bigaut1, Thibaut Fabacher2, Laurent Kremer1, Jean-Claude Ongagna3, Arnaud Kwiatkowski4, François Sellal5, Didier Ferriby6, Sylvie Courtois7, Patrick Vermersch8, Nicolas Collongues1, Hélène Zéphir8, Jérôme De Seze1, Olivier Outteryck9. 1. Department of Neurology, Hôpitaux Universitaires de Strasbourg, Strasbourg, France/Clinical Investigation Center, INSERM U1434, Strasbourg, France/Biopathology of Myelin, Neuroprotection and Therapeutic Strategies, INSERM U1119, Strasbourg, France. 2. Groupe méthode en recherche clinique, Hôpitaux Universitaires de Strasbourg, Strasbourg, France. 3. Department of Neurology, Hôpitaux Universitaires de Strasbourg, Strasbourg, France. 4. Department of Neurology, Hôpital Saint Vincent De Paul, Groupement des Hôpitaux de l'Institut Catholique de Lille, Lille, France. 5. Department of Neurology, Hôpitaux Civils de Colmar, Colmar, France. 6. Department of Neurology, Centre Hospitalier de Tourcoing, Tourcoing, France. 7. Department of Neurology, Groupe Hospitalier de la Région de Mulhouse et Sud Alsace, Mulhouse, France. 8. Department of Neurology, Centre Hospitalier Universitaire de Lille, Lille, France. 9. Department of Neurology, Centre Hospitalier Universitaire de Lille, Lille, France/Department of Neuroradiology, Centre Hospitalier Universitaire de Lille, Lille, France.
Abstract
BACKGROUND: Data are needed on long-term effect of natalizumab (NTZ) in relapsing-remitting multiple sclerosis (RRMS). OBJECTIVES: To evaluate the time of onset of secondary progressive phase in patients with an RRMS treated with NTZ and to investigate predictive factors. METHODS: TYSTEN is an observational study. Patients starting NTZ between 2007 and 2012 were included and followed up until October 2018. Relapses, Expanded Disability Status Scale (EDSS) scores, and results of brain magnetic resonance imaging (MRI) were collected each year. Data were used to estimate the cumulative probability of several poor outcomes such as secondary progressive multiple sclerosis (SPMS) conversion, EDSS worsening, EDSS 4.0, and EDSS 6.0. RESULTS: 770 patients were included. The mean follow-up duration was 97 months and the mean time exposure to NTZ was 66 months. At 10 years, the cumulative probability of SPMS was 27.7%. Predictive factors for poor outcomes were a ⩾1-point increase in EDSS score from baseline, new T2 lesion or T1 gadolinium-enhancing lesion, the occurrence of relapse at 1 or 2 years and No Evidence of Disease Activity (NEDA-3; no relapse, no new T2 or T1 gadolinium-enhancing lesions, no progression) was a protective factor. CONCLUSION: In our cohort of patients treated with NTZ, poor outcomes were infrequent and are driven by disease activity.
BACKGROUND: Data are needed on long-term effect of natalizumab (NTZ) in relapsing-remitting multiple sclerosis (RRMS). OBJECTIVES: To evaluate the time of onset of secondary progressive phase in patients with an RRMS treated with NTZ and to investigate predictive factors. METHODS:TYSTEN is an observational study. Patients starting NTZ between 2007 and 2012 were included and followed up until October 2018. Relapses, Expanded Disability Status Scale (EDSS) scores, and results of brain magnetic resonance imaging (MRI) were collected each year. Data were used to estimate the cumulative probability of several poor outcomes such as secondary progressive multiple sclerosis (SPMS) conversion, EDSS worsening, EDSS 4.0, and EDSS 6.0. RESULTS: 770 patients were included. The mean follow-up duration was 97 months and the mean time exposure to NTZ was 66 months. At 10 years, the cumulative probability of SPMS was 27.7%. Predictive factors for poor outcomes were a ⩾1-point increase in EDSS score from baseline, new T2 lesion or T1 gadolinium-enhancing lesion, the occurrence of relapse at 1 or 2 years and No Evidence of Disease Activity (NEDA-3; no relapse, no new T2 or T1 gadolinium-enhancing lesions, no progression) was a protective factor. CONCLUSION: In our cohort of patients treated with NTZ, poor outcomes were infrequent and are driven by disease activity.
Authors: Michael Guger; Christian Enzinger; Fritz Leutmezer; Franziska Di Pauli; Jörg Kraus; Stefan Kalcher; Erich Kvas; Thomas Berger Journal: J Neurol Date: 2021-04-22 Impact factor: 4.849