Relapses Requiring Intravenous Steroid Use and Multiple-Sclerosis-related Hospitalizations : Integrated Analysis of the Delayed-release Dimethyl Fumarate Phase III Studies

Kód výsledku v IS VaVaI

<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F00216208%3A11110%2F15%3A10313208" target="_blank" >RIV/00216208:11110/15:10313208 - isvavai.cz</a>

Nalezeny alternativní kódy

RIV/00064165:_____/15:10313208

Výsledek na webu

<a href="http://dx.doi.org/10.1016/j.clinthera.2015.09.011" target="_blank" >http://dx.doi.org/10.1016/j.clinthera.2015.09.011</a>

DOI - Digital Object Identifier

<a href="http://dx.doi.org/10.1016/j.clinthera.2015.09.011" target="_blank" >10.1016/j.clinthera.2015.09.011</a>

Jazyk výsledku

angličtina

Název v původním jazyce

Relapses Requiring Intravenous Steroid Use and Multiple-Sclerosis-related Hospitalizations : Integrated Analysis of the Delayed-release Dimethyl Fumarate Phase III Studies

Popis výsledku v původním jazyce

Purpose The purpose was to report the effects of delayed-release dimethyl fumarate (DMF; also known as gastro-resistant DMF) on the number of relapses requiring intravenous (IV) steroids and multiple sclerosis (MS)-related hospitalizations using integrated data from the Phase III DEFINE and CONFIRM studies. Data DEFINE and CONFIRM were pooled and analyzed using a negative binomial regression model (adjusted for study and region). Data obtained after subjects switched to an alternative MS therapy were not included in the analysis. Only relapses confirmed by the Independent Neurology Evaluation Committee were included in the analysis of relapses requiring IV steroids. Findings The study population (intention-to-treat) comprised 2301 patients who receivedeither placebo (n = 771), DMF BID (n = 769), or DMF TID (n = 761). Baseline demographic and disease characteristics were generally well balanced among treatment groups. Throughout the 2-year studies, the total number of relapses treated

Název v anglickém jazyce

Relapses Requiring Intravenous Steroid Use and Multiple-Sclerosis-related Hospitalizations : Integrated Analysis of the Delayed-release Dimethyl Fumarate Phase III Studies

Popis výsledku anglicky

Purpose The purpose was to report the effects of delayed-release dimethyl fumarate (DMF; also known as gastro-resistant DMF) on the number of relapses requiring intravenous (IV) steroids and multiple sclerosis (MS)-related hospitalizations using integrated data from the Phase III DEFINE and CONFIRM studies. Data DEFINE and CONFIRM were pooled and analyzed using a negative binomial regression model (adjusted for study and region). Data obtained after subjects switched to an alternative MS therapy were not included in the analysis. Only relapses confirmed by the Independent Neurology Evaluation Committee were included in the analysis of relapses requiring IV steroids. Findings The study population (intention-to-treat) comprised 2301 patients who receivedeither placebo (n = 771), DMF BID (n = 769), or DMF TID (n = 761). Baseline demographic and disease characteristics were generally well balanced among treatment groups. Throughout the 2-year studies, the total number of relapses treated

Druh

J_x - Nezařazeno - Článek v odborném periodiku (Jimp, Jsc a Jost)

CEP obor

FH - Neurologie, neurochirurgie, neurovědy

OECD FORD obor

—

Projekt

—

Návaznosti

I - Institucionalni podpora na dlouhodoby koncepcni rozvoj vyzkumne organizace

Rok uplatnění

2015

Kód důvěrnosti údajů

S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů

Název periodika

Clinical Therapeutics

ISSN

0149-2918

e-ISSN

—

Svazek periodika

37

Číslo periodika v rámci svazku

11

Stát vydavatele periodika

US - Spojené státy americké

Počet stran výsledku

9

Strana od-do

2543-2551

Kód UT WoS článku

000366242900017

EID výsledku v databázi Scopus

2-s2.0-84947942315