Superior MRI outcomes with alemtuzumab compared with subcutaneous interferon beta-1a in MS

Kód výsledku v IS VaVaI

<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F00216208%3A11110%2F16%3A10328396" target="_blank" >RIV/00216208:11110/16:10328396 - isvavai.cz</a>

Výsledek na webu

<a href="http://www.neurology.org/content/87/14/1464.full" target="_blank" >http://www.neurology.org/content/87/14/1464.full</a>

DOI - Digital Object Identifier

<a href="http://dx.doi.org/10.1212/WNL.0000000000003169" target="_blank" >10.1212/WNL.0000000000003169</a>

Jazyk výsledku

angličtina

Název v původním jazyce

Superior MRI outcomes with alemtuzumab compared with subcutaneous interferon beta-1a in MS

Popis výsledku v původním jazyce

Objective: To describe detailed MRI results from 2 head-to-head phase III trials, Comparison of Alemtuzumab and Rebif Efficacy in Multiple Sclerosis Study I (CARE-MS I; NCT00530348) and Study II (CARE-MS II; NCT00548405), of alemtuzumab vs subcutaneous interferon beta-1a (SC IFN-beta-1a) in patients with active relapsing-remitting multiple sclerosis (RRMS). Methods: The impact of alemtuzumab 12 mg vs SC IFN-beta-1a 44 mg on MRI measures was evaluated in patients with RRMS who were treatment-naive (CARE-MS I) or who had an inadequate response, defined as at least one relapse, to prior therapy (CARE-MS II). Results: Both treatments prevented T2-hyperintense lesion volume increases from baseline. Alemtuzumab was more effective than SC IFN-beta-1a on most lesion-based endpoints in both studies (p < 0.05), including decreased risk of new/enlarging T2 lesions over 2 years and gadolinium-enhancing lesions at year 2. Reduced risk of new T1 lesions (p < 0.0001) and gadolinium-enhancing lesion conversion to T1-hypointense black holes (p = 0.0078) were observed with alemtuzumab vs SC IFN-beta-1a in CARE-MS II. Alemtuzumab slowed brain volume loss over 2 years in CARE-MS I (p, 0.0001) and II (p = 0.012) vs SC IFN-beta-1a. Conclusions: Alemtuzumab demonstrated greater efficacy than SC IFN-beta-1a on MRI endpoints in active RRMS. The superiority of alemtuzumab was more prominent during the second year of both studies. These findings complement the superior clinical efficacy of alemtuzumab over SC IFN-beta-1a in RRMS. ClinicalTrials.gov identifier: NCT00530348 and NCT00548405. Classification of evidence: The results reported here provide Class I evidence that, for patients with active RRMS, alemtuzumab is superior to SC IFN-beta-1a on multiple MRI endpoints.

Název v anglickém jazyce

Superior MRI outcomes with alemtuzumab compared with subcutaneous interferon beta-1a in MS

Popis výsledku anglicky

Objective: To describe detailed MRI results from 2 head-to-head phase III trials, Comparison of Alemtuzumab and Rebif Efficacy in Multiple Sclerosis Study I (CARE-MS I; NCT00530348) and Study II (CARE-MS II; NCT00548405), of alemtuzumab vs subcutaneous interferon beta-1a (SC IFN-beta-1a) in patients with active relapsing-remitting multiple sclerosis (RRMS). Methods: The impact of alemtuzumab 12 mg vs SC IFN-beta-1a 44 mg on MRI measures was evaluated in patients with RRMS who were treatment-naive (CARE-MS I) or who had an inadequate response, defined as at least one relapse, to prior therapy (CARE-MS II). Results: Both treatments prevented T2-hyperintense lesion volume increases from baseline. Alemtuzumab was more effective than SC IFN-beta-1a on most lesion-based endpoints in both studies (p < 0.05), including decreased risk of new/enlarging T2 lesions over 2 years and gadolinium-enhancing lesions at year 2. Reduced risk of new T1 lesions (p < 0.0001) and gadolinium-enhancing lesion conversion to T1-hypointense black holes (p = 0.0078) were observed with alemtuzumab vs SC IFN-beta-1a in CARE-MS II. Alemtuzumab slowed brain volume loss over 2 years in CARE-MS I (p, 0.0001) and II (p = 0.012) vs SC IFN-beta-1a. Conclusions: Alemtuzumab demonstrated greater efficacy than SC IFN-beta-1a on MRI endpoints in active RRMS. The superiority of alemtuzumab was more prominent during the second year of both studies. These findings complement the superior clinical efficacy of alemtuzumab over SC IFN-beta-1a in RRMS. ClinicalTrials.gov identifier: NCT00530348 and NCT00548405. Classification of evidence: The results reported here provide Class I evidence that, for patients with active RRMS, alemtuzumab is superior to SC IFN-beta-1a on multiple MRI endpoints.

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

2016

Kód důvěrnosti údajů

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

Název periodika

Neurology

ISSN

0028-3878

e-ISSN

—

Svazek periodika

87

Číslo periodika v rámci svazku

14

Stát vydavatele periodika

US - Spojené státy americké

Počet stran výsledku

9

Strana od-do

1464-1472

Kód UT WoS článku

000385656700014

EID výsledku v databázi Scopus

2-s2.0-84989942285