Serum palivizumab level is associated with decreased severity of respiratory syncytial virus disease in high-risk infants.

Abstract

Monthly doses of palivizumab, an RSV-specific monoclonal antibody, reduce RSV-related hospitalizations (RSVH) in high-risk children; however, no specific palivizumab level has been correlated with disease severity in humans. A post hoc analysis of a previous randomized, placebo-controlled trial evaluated the relationship between serum palivizumab level at the time of RSVH and disease severity. Pediatric intensive care unit (PICU) admission was the primary severity marker. Relationships were evaluated between disease severity and gestational age, age at enrollment, age at RSVH, presence of bronchopulmonary dysplasia, sex, race, multiple birth, household smoking, daycare attendance, sibling(s), family history of atopy, duration between most recent palivizumab dose and RSVH, and palivizumab level at RSVH. Forty-two (87.5%) of 48 palivizumab recipients with RSVH had palivizumab levels drawn; 11 were admitted to the PICU. Mean palivizumab levels were lower in PICU-admitted subjects (47.2 μg/mL) vs. non-PICU subjects (98.7 μg/mL; P < 0.0001); there were no statistically significant differences in other variables examined. The probability of PICU admission declined with higher palivizumab levels; there were no PICU admissions with levels ≥ 92 μg/mL. In multivariate analyses, palivizumab level was the only independent predictor of PICU admission (P = 0.009). Palivizumab level also correlated with duration of RSVH and PICU stay, supplemental oxygen use and duration, and mechanical ventilation use and duration (P < 0.05). Higher palivizumab level was associated with decreased disease severity in high-risk infants with RSVH. Findings suggest that palivizumab level has clinical relevance, and adherence to timely monthly dosing may confer additional protection among high-risk children receiving palivizumab.

• Authors: Michael L Forbes, Veena R Kumar, Ram Yogev, Xionghua Wu, Gabriel J Robbie, Christopher S Ambrose
• Journal: Human vaccines & immunotherapeutics (Hum Vaccin Immunother) Vol. 10 Issue 10 Pg. 2789-94 ( 2014) ISSN: 2164-554X [Electronic] United States
• PMID: 25483663 (Publication Type: Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Antibodies, Monoclonal, Humanized
• Antiviral Agents
• Palivizumab

Topics

• Antibodies, Monoclonal, Humanized (blood, therapeutic use)
• Antiviral Agents (blood, therapeutic use)
• Bronchopulmonary Dysplasia (epidemiology)
• Disease Progression
• Female
• Hospitalization (statistics & numerical data)
• Humans
• Infant
• Infant, Premature
• Intensive Care Units, Pediatric (statistics & numerical data)
• Male
• Palivizumab
• Respiratory Syncytial Virus Infections (drug therapy, epidemiology, prevention & control)
• Respiratory Syncytial Viruses (immunology)
• Retrospective Studies
• Risk
• Risk Factors