Motavizumab for prophylaxis of Respiratory Syncytial Virus in high-risk children: A noninferiority trial

Carbonell-Estrany, Xavier, Simoes, Eric A. F., Dagan, Ron, Hall, Caroline B., Harris, Brian, Hultquist, Micki, Connor, Edward M., Losonsky, Genevieve A., Motavizumab Study Group and Nissen, Michael D. (2010) Motavizumab for prophylaxis of Respiratory Syncytial Virus in high-risk children: A noninferiority trial. Pediatrics, 125 1: e35-e51. doi:10.1542/peds.2008-1036

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Author Carbonell-Estrany, Xavier
Simoes, Eric A. F.
Dagan, Ron
Hall, Caroline B.
Harris, Brian
Hultquist, Micki
Connor, Edward M.
Losonsky, Genevieve A.
Motavizumab Study Group
Nissen, Michael D.
Title Motavizumab for prophylaxis of Respiratory Syncytial Virus in high-risk children: A noninferiority trial
Journal name Pediatrics   Check publisher's open access policy
ISSN 0031-4005
1098-4275
Publication date 2010-01
Year available 2009
Sub-type Article (original research)
DOI 10.1542/peds.2008-1036
Open Access Status File (Author Post-print)
Volume 125
Issue 1
Start page e35
End page e51
Total pages 17
Editor Jerold F. Lucey
Lewis R. First
Joe Puskarz
Place of publication Elk Grove Village, IL, U.S.A.
Publisher American Academy of Pediatrics
Collection year 2011
Language eng
Subject 060506 Virology
060502 Infectious Agents
920115 Respiratory System and Diseases (incl. Asthma)
920204 Evaluation of Health Outcomes
Formatted abstract
OBJECTIVE:
Palivizumab reduces respiratory syncytial virus (RSV) hospitalization in children at high risk by 50% compared with placebo. We compared the efficacy and safety of motavizumab, an investigational monoclonal antibody with enhanced anti-RSV activity in preclinical studies, with palivizumab.

METHODS:
This randomized, double-blind, multinational, phase 3, noninferiority trial assessed safety and RSV hospitalization in 6635 preterm infants aged 6 months at enrollment or children aged 24 months with chronic lung disease of prematurity who received 15 mg/kg palivizumab or motavizumab monthly. Secondary end points included outpatient medically attended lower respiratory tract infections (MALRIs), RSV-specific LRIs, otitis media, antibiotic use, development of antimotavizumab antibodies, and motavizumab serum concentrations.

RESULTS:
Motavizumab recipients had a 26% relative reduction in RSV hospitalization compared with palivizumab recipients, achieving noninferiority. Motavizumab was superior to palivizumab for reduction of RSV-specific outpatient MALRIs (50% relative reduction). Overall, adverse events (AEs) were not significantly different between groups. Cutaneous events were reported in 2 percentage points more motavizumab recipients (7.2% vs 5.1%); most were mild, but 0.3% resulted in dosing discontinuation. Antidrug antibodies (ADA) were detected in 1.8% of motavizumab recipients. Patients with anti-drug antibody reported 6 RSV events and 17 cutaneous events.

CONCLUSIONS:
Children receiving prophylaxis with motavizumab or palivizumab had low rates of RSV hospitalization; motavizumab recipients experienced 50% fewer RSV MALRIs than palivizumab recipients. AEs were similar in both groups, although cutaneous AEs were higher for motavizumab recipients. Motavizumab may offer an improved alternative in prophylaxis for serious RSV disease in infants and children at high risk.
Keyword Motavizumab
Respiratory syncytial virus
Pediatric
Respiratory infection
Clinical trial
Palivizumab
Q-Index Code CX
Q-Index Status Confirmed Code
Institutional Status Non-UQ
Additional Notes Originally published online December 14, 2009.

Document type: Journal Article
Sub-type: Article (original research)
Collections: Non HERDC
ERA White List Items
School of Chemistry and Molecular Biosciences
Clinical Medical Virology Centre Publications
 
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Created: Thu, 12 Aug 2010, 12:54:42 EST by Lesley Arnicar on behalf of Clinical Medical Virology Centre