2% (95% CI 3.3%, 10.3%); lyophilized 3.0% (1.1%, 6.42%)] and respiratory, thoracic and mediastinal disorders [liquid, 0.0% (0.0%, 1.7%); lyophilized, 2.0% (0.5%, 5.0%)]. For infections and infestations, SAEs that may have contributed to a higher incidence in the liquid palivizumab group included bronchiolitis and viral infection. There was no evidence
of an increase in RSV disease with liquid palivizumab. Of the 9 events of bronchiolitis, 7 were tested check details locally for RSV (liquid, n = 5; lyophilized, n = 2) and all 7 were negative. A single event of bronchopneumonia (in the liquid palivizumab group) was tested locally and was negative for RSV. Both events of viral infection were negative for RSV based on local testing. The events of respiratory, thoracic and mediastinal disorders reported in the lyophilized palivizumab group were respiratory distress (2 subjects), and apnea, asphyxia, and dyspnea (each in 1 subject). The SAE of asphyxia resulted selleckchem in death (described above). The remaining events occurred sporadically throughout dosing; all required hospitalization
and resolved within 2–10 days after treatment. The events of apnea, dyspnea, and asphyxia were tested locally for RSV and all were negative. Antidrug Antibodies At baseline, none of the subjects exhibited PD-1/PD-L1 inhibitor antipalivizumab antibodies. From study days 240–300, antipalivizumab antibodies were detected in none of the subjects in the liquid palivizumab group and in 1/188 subject (0.5%) in the lyophilized palivizumab group (at 154 days post final dose), with an overall percent positive of 0.3% (1/379) for both treatment groups combined. Given these observations and the number of subjects studied, the true ADA percent positive, based on the upper limit of the exact 95% CI, is at most 1.9% for the liquid palivizumab group, 2.9% for the lyophilized palivizumab group, and 1.5% for both treatments combined. Discussion Liquid palivizumab was developed to avoid the need
for reconstitution required by lyophilized palivizumab. Since 2006, liquid palivizumab has been GPX6 the only formulation distributed in the United States, and is estimated to have been administered to one million infants . Findings from this study of children at high risk for serious RSV disease showed that liquid and lyophilized formulations exhibit a comparable safety profile with similar reported SAEs. The present safety findings generally are consistent with findings from a randomized, double-blind, cross-over study of infants aged ≤6 months who were born ≤35 weeks gestational age . In that study, the percentages of infants with SAEs were similar (liquid, 3.3%; lyophilized, 2.6%) . The type and frequency of SAEs reported were similar between the liquid and lyophilized palivizumab groups .