Special comments - Neonatal Intensive Care Drug Manual

Evidence
|
Palivizumab is a humanised monoclonal antibody (comprised of 95% human and 5% murine amino acid sequences) which exhibits neutralising and fusion-inhibitory activity against RSV. Palivizumab is registered in Australia for prevention of serious lower respiratory tract disease caused by RSV in children at high risk of RSV disease. There is no consensus regarding the use of palivizumab in Australia. [4]
Seasonality of RSV illness: The peak in RSV-coded hospitalizations in NSW, Australia 2001-2010 was between May and August with 81% of the total RSV-coded hospitalizations recorded between these months. [5]
Efficacy
Palivizumab for prevention of respiratory syncytial virus infection in children: Systematic review found 3 RCTs in a total of 2831 patients that compared palivizumab with placebo. [2] The doses of palivizumab varied across studies from 3 to 6 doses at 15 mg/kg per dose. Palivizumab reduced hospitalisation for RSV infection [3 trials, 2831 infants; RR 0.49, 95%CI 0.37, 0.64] and admission to ICU [2 trials, 2789 infants; RR 0.50, 95%CI 0.30, 0.81]. There was no difference in mortality [3 trials, 2831 infants; RR 0.69, 95%CI 0.42, 1.15] or use of mechanical ventilation [2 trials, 2789 infants; RR 1.10, 95%CI 0.20, 6.09].
Palivizumab versus motavizumab for prevention of respiratory syncytial virus infection in children: When compared to motavizumab, palivizumab recipients showed no significant difference in risk of RSV hospitalisation [2 trials, 7870 infants; RR 1.36, 95%CI 0.97, 1.90] and all-cause mortality [4 trials, 8265 infants; RR 0.74, 95%CI 0.38, 1.43]. In both cases, the proportion of children with any adverse events (AE) or any AE related to the study drug was similar between the two groups. [2] No studies were found for children with immunodeficiency, chronic neuromuscular disease or congenital anomalies. [2]
Immunoglobulin treatment for hospitalised infants and young children with respiratory syncytial virus infection: Systematic review found no difference in mortality [3 trials, 196 infants; RR 0.87, 95%CI 0.14, 5.27] or days hospitalisation [5 trials, 324 infants; MD -0.70; 95%CI -1.83, 0.42] from use of palivizumab or motavizumab for infants and children under 3 years of age with RSV infection. [6]
Palivizumab for prophylaxis against respiratory syncytial virus infection in children with cystic fibrosis: One RCT with 186 infants with cystic fibrosis. One admission in each arm and the incidence of adverse events was similar in both groups. There is insufficient evidence to determine efficacy of palivizumab for prophylaxis against respiratory syncytial virus infection in children with cystic fibrosis. [7]
Safety
A single trial [2, 8] that included 1287 infants comparing palivizumab with placebo reported no difference in the number of children with an adverse event [RR 0.99, 95%CI 0.97, 1.01], a reduction in the number with a serious adverse event [1 trial, 1287 infants; RR 0.88, 95%CI 0.80, 0.96], and no difference in related serious adverse events [1 trial, 1287 infants; RR 0.14 [0.01, 2.80]. Two cases of anaphylaxis (<1 case per 100,000 patients) have been reported to the FDA. [9]
Palivizumab does not interfere with the immune response to live or inactivated vaccines. The childhood immunization schedule should be followed for all children, regardless of palivizumab use. [10]
1> |