Ravulizumab (ALXN1210) vs eculizumab in C5-inhibitor-experienced adult patients with PNH: the 302 study.
Adult
Antibodies, Monoclonal, Humanized
/ therapeutic use
Antineoplastic Combined Chemotherapy Protocols
/ therapeutic use
Complement C5
/ antagonists & inhibitors
Complement Inactivating Agents
/ therapeutic use
Drug Resistance, Neoplasm
/ drug effects
Female
Follow-Up Studies
Hemoglobinuria, Paroxysmal
/ drug therapy
Hemolysis
/ drug effects
Humans
Male
Middle Aged
Prognosis
Salvage Therapy
Journal
Blood
ISSN: 1528-0020
Titre abrégé: Blood
Pays: United States
ID NLM: 7603509
Informations de publication
Date de publication:
07 02 2019
07 02 2019
Historique:
received:
26
09
2018
accepted:
18
11
2018
pubmed:
5
12
2018
medline:
19
10
2019
entrez:
5
12
2018
Statut:
ppublish
Résumé
Ravulizumab, a new complement component C5 inhibitor administered every 8 weeks, was noninferior to eculizumab administered every 2 weeks in complement-inhibitor-naive patients with paroxysmal nocturnal hemoglobinuria (PNH). This study assessed noninferiority of ravulizumab to eculizumab in clinically stable PNH patients during previous eculizumab therapy. In this phase 3, open-label, multicenter study, 195 PNH patients on labeled-dose (900 mg every 2 weeks) eculizumab for >6 months were randomly assigned 1:1 to switch to ravulizumab (n = 97) or continue eculizumab (n = 98). Primary efficacy end point was percentage change in lactate dehydrogenase (LDH) from baseline to day 183. Key secondary end points included proportion of patients with breakthrough hemolysis, change in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue score, transfusion avoidance, and stabilized hemoglobin. In 191 patients completing 183 days of treatment, ravulizumab was noninferior to eculizumab (
Identifiants
pubmed: 30510079
pii: S0006-4971(20)42811-3
doi: 10.1182/blood-2018-09-876805
pmc: PMC6368201
doi:
Substances chimiques
Antibodies, Monoclonal, Humanized
0
Complement C5
0
Complement Inactivating Agents
0
eculizumab
A3ULP0F556
ravulizumab
C3VX249T6L
Banques de données
ClinicalTrials.gov
['NCT03056040']
Types de publication
Clinical Trial, Phase III
Comparative Study
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
540-549Commentaires et corrections
Type : CommentIn
Informations de copyright
© 2019 by The American Society of Hematology.
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