Safety and efficacy of ofatumumab in relapsing-remitting multiple sclerosis A phase 2 study

Kód výsledku v IS VaVaI

<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F00216208%3A11110%2F14%3A10227286" target="_blank" >RIV/00216208:11110/14:10227286 - isvavai.cz</a>

Nalezeny alternativní kódy

RIV/00064165:_____/14:10227286

Výsledek na webu

<a href="http://dx.doi.org/10.1212/WNL.0000000000000125" target="_blank" >http://dx.doi.org/10.1212/WNL.0000000000000125</a>

DOI - Digital Object Identifier

<a href="http://dx.doi.org/10.1212/WNL.0000000000000125" target="_blank" >10.1212/WNL.0000000000000125</a>

Jazyk výsledku

angličtina

Název v původním jazyce

Safety and efficacy of ofatumumab in relapsing-remitting multiple sclerosis A phase 2 study

Popis výsledku v původním jazyce

Objectives:We present the first study to explore safety and efficacy of the human CD20 monoclonal antibody ofatumumab in relapsing-remitting multiple sclerosis (RRMS).Methods:In this randomized, double-blind, placebo-controlled study, patients received 2ofatumumab infusions (100 mg, 300 mg, or 700 mg) or placebo 2 weeks apart. At week 24, patients received alternate treatment. Safety and efficacy were assessed.Results:Thirty-eight patients were randomized (ofatumumab/placebo, n = 26; placebo/ofatumumab, n = 12) and analyzed; 36 completed the study. Two patients in the 300-mg group withdrew from the study because of adverse events. No unexpected safety signals emerged. Infusion-related reactions were common on the first infusion day but not observed onthe second infusion day. None of the patients developed human anti-human antibodies. Ofatumumab was associated with profound selective reduction of B cells as measured by CD19(+) expression. New brain MRI lesion activity was suppressed (

Název v anglickém jazyce

Safety and efficacy of ofatumumab in relapsing-remitting multiple sclerosis A phase 2 study

Popis výsledku anglicky

Objectives:We present the first study to explore safety and efficacy of the human CD20 monoclonal antibody ofatumumab in relapsing-remitting multiple sclerosis (RRMS).Methods:In this randomized, double-blind, placebo-controlled study, patients received 2ofatumumab infusions (100 mg, 300 mg, or 700 mg) or placebo 2 weeks apart. At week 24, patients received alternate treatment. Safety and efficacy were assessed.Results:Thirty-eight patients were randomized (ofatumumab/placebo, n = 26; placebo/ofatumumab, n = 12) and analyzed; 36 completed the study. Two patients in the 300-mg group withdrew from the study because of adverse events. No unexpected safety signals emerged. Infusion-related reactions were common on the first infusion day but not observed onthe second infusion day. None of the patients developed human anti-human antibodies. Ofatumumab was associated with profound selective reduction of B cells as measured by CD19(+) expression. New brain MRI lesion activity was suppressed (

Druh

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

CEP obor

FH - Neurologie, neurochirurgie, neurovědy

OECD FORD obor

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Projekt

—

Návaznosti

Z - Vyzkumny zamer (s odkazem do CEZ)<br>I - Institucionalni podpora na dlouhodoby koncepcni rozvoj vyzkumne organizace

Rok uplatnění

2014

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

82

Číslo periodika v rámci svazku

7

Stát vydavatele periodika

US - Spojené státy americké

Počet stran výsledku

9

Strana od-do

573-581

Kód UT WoS článku

000336498300008

EID výsledku v databázi Scopus

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