Abstract
Aims: To describe the safety and tolerability of motavizumab vs palivizumab for prophylaxis of serious respiratory syncytial virus (RSV) disease in children with hemodynamically significant congenital heart disease (hs-CHD).Methods: This randomized, double-blind, palivizumab-controlled multinational study was designed as a safety study (primary endpoint) and was not powered for efficacy. Secondary endpoints included the incidence of RSV hospitalization (2 seasons) and RSV outpatient medically attended lower respiratory infection (MALRI, 1 season). Patients aged ≤24 months with hs-CHD (N=1236) were enrolled and stratified by study site and cyanotic status. Five monthly doses of palivizumab or motavizumab were administered during RSV season. Nasal secretions obtained following cardiac/respiratory hospitalizations and outpatient LRIs were tested for RSV by real-time RT-PCR.Results: Mortality was low (< 2%) and similar between groups. Motavizumab-treated cyanotic patients showed no tendency for increased mortality/morbidity compared with palivizumab. Adverse events (AEs) and serious AEs were similar with the exception of ∼3 percentage point increase in skin and subcutaneous tissue AEs in motavizumab recipients compared with palivizumab. Generally, skin AEs were transient and did not recur after subsequent doses. Rates of RSV hospitalization and RSV outpatient MALRI were similar between treatment groups (relative risk [RR]: 0.746; 95% CI=0.344-1.586 and RR: 0.495; 95% CI=0.101-1.989, respectively, P=NS for both).Conclusions: Motavizumab and palivizumab had similar safety profiles in children ≤24 months with hemodynamically significantly CHD; however, skin events were increased in motavizumab recipients. Safety and efficacy were consistent with another study comparing motavizumab with palivizumab in premature infants without CHD.Sponsored by MedImmune.
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