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Motavizumab may be effective in preventing serious respiratory syncytial virus
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Motavizumab appears to be equivalent to palivizumab in safety and efficacy for prophylaxis of serious respiratory syncytial virus (RSV) in infants and high-risk children, results from a recent study suggested.
“Palivizumab has been used since 1998 in the United States and 61 other countries for passive prevention of serious RSV in children at high risk,” noted Xavier Carbonell-Estrany, MD, from Hospital de Sant Joan de Deu, in Barcelona, and other researchers from 347 sites worldwide. “Although motavizumab has greater neutralization activity against RSV in preclinical studies, it was unclear whether this would translate into improved clinical efficacy.”
The researchers conducted a noninferiority study to determine whether motavizumab was at least as beneficial as or potentially superior to palivizumab in decreasing either serious RSV disease or incidence of RSV medically attended lower respiratory tract infection (MALRI). They also evaluated the frequency and type of adverse events and serious adverse events so as to evaluate motavizumab’s safety profile as well.
This multinational, randomized, double blind, phase-3 trial included 6,635 preterm infants aged 6 months or younger at enrollment or children aged 24 months or less with chronic lung disease that required medical management within six months of the study. Each infant or child received one monthly 15 mg/kg-dose of palivizumab or motavizumab for five months, with palivizumab recipients acting as the control group.
Results showed low rates of hospitalization resulting from RSV in both groups. Although motavizumab recipients did have a 26% relative reduction in RSV hospitalization, demonstrating its noninferiority, this value did not meet the researchers’ superiority criteria. However, the research data indicated motavizumab reduced RSV-specific outpatient MALRI by 50% compared with palivizumab (2.0% vs. 3.9%; P = 0.005).
Adverse events and serious adverse events also occurred in both motavizumab and palivizumab recipients, but researchers said they were generally mild and few resulted in dosage discontinuation. Additionally, no significant differences between incidence and severity of adverse events and serious adverse events existed between the two groups. However, palivizumab recipients were more likely to experience psychiatric adverse events, such as agitation and insomnia, whereas motavizumab recipients were more likely to experience skin adverse events.
After analyzing these study results, the researchers concluded that motavizumab’s potential for effective use in a clinical setting may be possible.
“Although not better than palivizumab in reducing RSV-associated hospitalizations, motavizumab did demonstrate a significant reduction in outpatient MALRI compared with palivizumab. As such, motavizumab may offer an improved alternative for preventing serious RSV disease in high-risk infants and children.”
Carbonell-Estrany X. Pediatrics. 2010;125:e35-e51.