Comparative efficacy of first-line natalizumab vs IFN-Beta or glatiramer acetate in relapsing MS

Kód výsledku v IS VaVaI

<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F00064165%3A_____%2F16%3A10323560" target="_blank" >RIV/00064165:_____/16:10323560 - isvavai.cz</a>

Nalezeny alternativní kódy

RIV/00216208:11110/16:10323560

Výsledek na webu

<a href="http://dx.doi.org/10.1212/CPJ.0000000000000227" target="_blank" >http://dx.doi.org/10.1212/CPJ.0000000000000227</a>

DOI - Digital Object Identifier

<a href="http://dx.doi.org/10.1212/CPJ.0000000000000227" target="_blank" >10.1212/CPJ.0000000000000227</a>

Jazyk výsledku

angličtina

Název v původním jazyce

Comparative efficacy of first-line natalizumab vs IFN-Beta or glatiramer acetate in relapsing MS

Popis výsledku v původním jazyce

Methods: The study population initiated IFN-Beta/GA in the MSBase Registry or natalizumab in the Tysabri Observational Program, had >=3 months of on-treatment follow-up, and had active RRMS, defined as >=1 gadolinium-enhancing lesion on cerebral MRI at baseline or >=1 relapse within the 12 months prior to baseline. Baseline demographics and disease characteristics were balanced between propensity-matched groups. Annualized relapse rate (ARR), time to first relapse, treatment persistence, and disability outcomes were compared between matched treatment arms in the total population (n 366/group) and subgroups with higher baseline disease activity. Results: First-line natalizumab was associated with a 68% relative reduction in ARR from a mean (SD) of 0.63 (0.92) on IFN-Beta/GA to 0.20 (0.63) (p [signed-rank] < 0.0001), a 64% reduction in the rate of first relapse (hazard ratio [HR] 0.36, 95% confidence interval [CI] 0.28-0.47; p < 0.001), and a 27% reduction in the rate of discontinuation (HR 0.73, 95% CI 0.58-0.93; p 0.01), compared with first-line IFN-Beta/GA therapy. Confirmed disability progression and area under the Expanded Disability Status Scale-time curve analyses were not significant. Similar relapse and treatment persistence results were observed in each of the higher disease activity subgroups. Conclusions: This study provides Class IV evidence that first-line natalizumab for RRMS improves relapse and treatment persistence outcomes compared to first-line IFN-Beta/GA. This needs to be balanced against the risk of progressive multifocal leukoencephalopathy in natalizumab-treated patients. Classification of evidence: This study provides Class IV evidence that first-line natalizumab for RRMS improves relapse rates and treatment persistence outcomes compared to first-line IFN-Beta/GA.

Název v anglickém jazyce

Comparative efficacy of first-line natalizumab vs IFN-Beta or glatiramer acetate in relapsing MS

Popis výsledku anglicky

Methods: The study population initiated IFN-Beta/GA in the MSBase Registry or natalizumab in the Tysabri Observational Program, had >=3 months of on-treatment follow-up, and had active RRMS, defined as >=1 gadolinium-enhancing lesion on cerebral MRI at baseline or >=1 relapse within the 12 months prior to baseline. Baseline demographics and disease characteristics were balanced between propensity-matched groups. Annualized relapse rate (ARR), time to first relapse, treatment persistence, and disability outcomes were compared between matched treatment arms in the total population (n 366/group) and subgroups with higher baseline disease activity. Results: First-line natalizumab was associated with a 68% relative reduction in ARR from a mean (SD) of 0.63 (0.92) on IFN-Beta/GA to 0.20 (0.63) (p [signed-rank] < 0.0001), a 64% reduction in the rate of first relapse (hazard ratio [HR] 0.36, 95% confidence interval [CI] 0.28-0.47; p < 0.001), and a 27% reduction in the rate of discontinuation (HR 0.73, 95% CI 0.58-0.93; p 0.01), compared with first-line IFN-Beta/GA therapy. Confirmed disability progression and area under the Expanded Disability Status Scale-time curve analyses were not significant. Similar relapse and treatment persistence results were observed in each of the higher disease activity subgroups. Conclusions: This study provides Class IV evidence that first-line natalizumab for RRMS improves relapse and treatment persistence outcomes compared to first-line IFN-Beta/GA. This needs to be balanced against the risk of progressive multifocal leukoencephalopathy in natalizumab-treated patients. Classification of evidence: This study provides Class IV evidence that first-line natalizumab for RRMS improves relapse rates and treatment persistence outcomes compared to first-line IFN-Beta/GA.

Druh

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

CEP obor

FH - Neurologie, neurochirurgie, neurovědy

OECD FORD obor

—

Projekt

—

Návaznosti

V - Vyzkumna aktivita podporovana z jinych verejnych zdroju

Rok uplatnění

2016

Kód důvěrnosti údajů

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

Název periodika

Neurology: Clinical Practice

ISSN

2163-0402

e-ISSN

—

Svazek periodika

6

Číslo periodika v rámci svazku

2

Stát vydavatele periodika

US - Spojené státy americké

Počet stran výsledku

14

Strana od-do

102-115

Kód UT WoS článku

000392602400009

EID výsledku v databázi Scopus

2-s2.0-84962686361