1. Clinical course and therapeutic management of spms in france: a retrospective real world multicentric observational study (odyssep study)
- Author
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Leray, Emmanuelle, Bastien, A., Rerat, K., Cognee-Chauvin, A., Raponi, E., Vukusic, S., Recherche en Pharmaco-épidémiologie et Recours aux Soins (REPERES), Université de Rennes 1 (UR1), Université de Rennes (UNIV-RENNES)-Université de Rennes (UNIV-RENNES)-École des Hautes Études en Santé Publique [EHESP] (EHESP), École des Hautes Études en Santé Publique [EHESP] (EHESP), Novartis Pharmaceutical Corporation, Centre Hospitalier le Vinatier [Bron], and Université de Rennes (UR)-École des Hautes Études en Santé Publique [EHESP] (EHESP)
- Subjects
[SDV]Life Sciences [q-bio] ,ComputingMilieux_MISCELLANEOUS - Abstract
International audience; Background - There is little data on the description of Secondary Progressive Multiple Sclerosis (SPMS) in France, notably because there is a lack oftherapeutic options to slow down the disease progression during that phase .Objectives - Describe and understand Secondary Progressive Multiple Sclerosis (SPMS) clinical course and therapeutic management in France.MethodsA retrospective multicentric observational study (ODYSSEP study) involving clinical longitudinal data was performed from the Frenchprospective national cohort of MS patients (OFSEP). Inclusion criteria were diagnosis of SPMS and at least one clinical visit between 2013,January 1st and 2017, June15th. Sensitivity analysis, was also performed to include undiagnosed SPMS patients in OFSEP database usingan automatized algorithm detecting patients with an increase in EDSS score without any activity(relapses and/or evidence of new MRIactivity) between two clinical evaluations. Results - 3140 SPMS patients were included in the main analysis, and 454 additional patients were identified through the sensitivity analysis.Median age at onset of progression was 47 years, and 68% of the patients were women. Almost half of patients (48%) had at least onerelapse during the follow-up; whereas only 10% had one during the last year of follow-up. Median EDSS at onset of progression was 4.5.During the follow-up of 9 years in mean, an increase of 1.6 points in EDSS score was observed. Treatments were described among the 908patients with progression onset after 2013 specifically. At the time of SPMS diagnosis, 35.4% of patients were untreated, 30.6% and 26.3%were treated by first- and second-line disease modifying therapy (DMT)(mainly IFN: 13.4%), 6.4% by off-label treatments and 1.3% bybiotin. During the SP phase, 63.6% of patients received at least one DMT; 30.6% were treated with first-line and 26.3% with second-lineDMT. At the last clinical visit, 56.2% of patients were still treated, mainly by off-label treatments (26.5%); first-line and second-line DMTwere less used (14.9% and 14.4%, respectively). Biotin was also frequently used (16.1%), either as the main treatment (10.6%) orassociated with a DMT (5.5%). Conclusions - These real world results from the French MS cohort indicate that most of SPMS patients are either untreated or taking off-label drugs. Itreflects the current lack of satisfactory therapeutic options during the secondary progressive phase of MS and underlines the urgent needfor new efficacious drugs specifically approved for SPMS.
- Published
- 2020