Teriflunomide reduces relapse-related neurological sequelae, hospitalizations and steroid use
| Autor: | Paul O'Connor, Gaelle Bego-Le-Bagousse, Fred D. Lublin, Christian Confavreux, Giancarlo Comi, Ludwig Kappos, Tomas Olsson, Aaron E. Miller, Mark S. Freedman, Jerry S. Wolinsky, Catherine Dive-Pouletty |
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| Přispěvatelé: | O'Connor, Pw, Lublin, Fd, Wolinsky, J, Confavreux, C, Comi, Giancarlo, Freedman, M, Olsson, Tp, Miller, Ae, Dive Pouletty, C, Bégo Le Bagousse, G, Kappos, L. |
| Jazyk: | angličtina |
| Rok vydání: | 2013 |
| Předmět: |
Male
Outcome assessment (Health Care) medicine.medical_specialty Toluidines Economics Population Clinical Neurology Administration Oral Hydroxybutyrates Placebo Multiple sclerosis Disability Evaluation chemistry.chemical_compound Multiple Sclerosis Relapsing-Remitting Double-Blind Method Adrenal Cortex Hormones Internal medicine Nitriles Teriflunomide Post-hoc analysis Humans Medicine Longitudinal Studies education education.field_of_study Chi-Square Distribution Original Communication Expanded Disability Status Scale Dose-Response Relationship Drug business.industry medicine.disease Surgery Hospitalization Clinical trial Treatment Outcome Neurology chemistry Crotonates Female Neurology (clinical) business Chi-squared distribution |
| Zdroj: | Journal of Neurology |
| Popis: | Multiple sclerosis (MS) relapses impose a substantial clinical and economic burden. Teriflunomide is a new oral disease-modifying therapy approved for the treatment of relapsing MS. We evaluated the effects of teriflunomide treatment on relapse-related neurological sequelae and healthcare resource use in a post hoc analysis of the Phase III TEMSO study. Confirmed relapses associated with neurological sequelae [defined by an increase in Expanded Disability Status Scale/Functional System (sequelae-EDSS/FS) ≥30 days post relapse or by the investigator (sequelae-investigator)] were analyzed in the modified intention-to-treat population (n = 1086). Relapses requiring hospitalization or intravenous (IV) corticosteroids, all hospitalizations, emergency medical facility visits (EMFV), and hospitalized nights for relapse were also assessed. Annualized rates were derived using a Poisson model with treatment, baseline EDSS strata, and region as covariates. Risks of sequelae and hospitalization per relapse were calculated as percentages and groups were compared with a χ2 test. Compared with placebo, teriflunomide reduced annualized rates of relapses with sequelae-EDSS/FS [7 mg by 32 % (p = 0.0019); 14 mg by 36 % (p = 0.0011)] and sequelae-investigator [25 % (p = 0.071); 53 % (p p = 0.015); 59 % (p p = 0.001); 34 % (p = 0.0003)]. Teriflunomide-treated patients spent fewer nights in hospital for relapse (p p = 0.01) and EMFV (p = 0.004). The impact of teriflunomide on relapse-related neurological sequelae and relapses requiring healthcare resources may translate into reduced healthcare costs. |
| Databáze: | OpenAIRE |
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