Image: PD. RSV.
1. Prophylaxis with an anti-respiratory syncytial virus (RSV) monoclonal antibody significantly reduced wheezing and recurrent wheezing among preterm infants.
2. The reduction in wheezing occurred regardless of family history of atopy.
Evidence Rating Level: 1 (Excellent)
Study Rundown: The MAKI trial found that prophylaxis of pre-term infants with the anti-RSV monoclonal antibody palivizumab significantly reduced wheezing and recurrent wheeze. The authors intended to probe what appears to be a causal relationship between RSV infection and recurrent wheeze – not to identify an effective treatment. The randomization and utilization of a virus-specific drug in this appropriately powered trial provides convincing evidence for a special role for RSV in the development of recurrent wheeze. Additionally the study showed that preventing RSV infection reduced wheezing regardless of family history of atopy. The integration of family history in the analysis further strengthens the authors’ argument for a causal role of RSV in recurrent wheeze. However, the study lacked sufficient time and power to address the issue of asthma. Also it did not include term infants; therefore the results may not be generalizable to the general population.
In-Depth [double blind randomized controlled trial]: The study investigated the relationship between RSV infection and recurrent wheeze. Preterm infants were randomly assigned to receive treatment with the anti-RSV monoclonal antibody palivizumab or placebo during RSV season. The primary outcome was number of parent-reported wheezing days during the first year of life. Additional outcomes included number of hospitalizations for laboratory-proven RSV infection, and prevalence of recurrent wheeze. The results showed a 61% relative reduction in number of days with parent-reported wheeze in children who received palivizumab when compared to those who received placebo (95% CI 56-65). Additionally infants treated with palivizumab had a lower incidence of RSV-related hospitalization (0.9% vs. 5.1% P=0.01) and lower recurrent wheeze (11.2% vs. 20.9% P=0.005) than those treated with placebo.
By Akira Shishido and Mitalee Patil
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