Observed Effectiveness of Palivizumab for 29-36-Week Gestation Infants
Harold J Farber1, Frederick J Buckwold2, Barry Lachman3
1Baylor College of Medicine, Texas Children's Hospital, and Texas Children's Health Plan, Houston, Texas; hjfarber@texaschildrens.org.
Insights
Palivizumab reduced respiratory syncytial virus hospitalizations in premature infants (29-32 weeks gestation) but increased other respiratory illness hospitalizations. This suggests careful consideration for palivizumab use in this population.
Area of Science:
- Pediatric Infectious Diseases
- Neonatal Care
- Public Health
Background:
- Respiratory syncytial virus (RSV) is a leading cause of infant hospitalization.
- Palivizumab has shown efficacy in reducing RSV hospitalizations in premature infants.
- Current guidelines recommend against palivizumab for healthy infants born at or after 29 weeks' gestation.
Purpose of the Study:
- To evaluate the impact of palivizumab on hospitalization rates for RSV and non-RSV bronchiolitis.
- To assess these effects in infants born between 29 and 36 weeks' gestation without chronic illnesses.
Main Methods:
- Retrospective analysis of Texas Medicaid claims data.
- Inclusion of infants born between April 1 and December 31, 2012-2014, with gestational ages of 29-36 weeks.
- Exclusion of infants with claims indicating chronic illnesses.
Main Results:
- Among infants 29-32 weeks' gestation, palivizumab use was linked to lower RSV hospitalization rates (3.1% vs. 5.0%, P=.04).
- However, palivizumab use was also associated with increased hospitalizations for bronchiolitis without RSV diagnosis (3.3% vs. 1.9%, P=.05) in this group.
- No significant differences in hospitalization rates were observed for infants 33-36 weeks' gestation based on palivizumab administration.
Conclusions:
- Palivizumab administration in infants 29-32 weeks' gestation without chronic illness was associated with reduced RSV hospitalizations.
- This use was also correlated with an increase in hospitalizations for bronchiolitis without an RSV diagnosis.
- Findings highlight a potential trade-off in palivizumab's clinical utility for this specific infant population.
Background:
Respiratory syncytial virus (RSV) is a common reason for hospitalization of infants. In clinical trials, palivizumab reduced RSV hospitalization rates for premature infants. The 2014 American Academy of Pediatrics clinical practice guideline advised against use of palivizumab for otherwise healthy infants ≥29 weeks' gestation. The aim of this study was to determine the effect of palivizumab administration on hospitalization rates for RSV and bronchiolitis without RSV diagnosis among infants 29 to 36 weeks' gestation who do not have chronic illness.
Methods:
Claims data were extracted from databases of 9 Texas Medicaid managed care programs. Eligible infants were 29 to 36 weeks' gestation, without claims suggesting chronic illness, and who were born between April 1 and December 31 of 2012, 2013, and 2014.
Results:
A total of 2031 eligible infants of 29 to 32 weeks' gestation and 12 066 infants of 33 to 36 weeks' gestation were identified; 41.5% of the infants 29 to 32 weeks' gestation and 3.7% of the infants 33 to 36 weeks' gestation had paid claims for dispensing of ≥1 palivizumab doses. Among the infants of 29 to 32 weeks' gestation, palivizumab dispensing was associated with reduced RSV hospitalization rates (3.1% vs 5.0%, P = .04) but increased hospitalizations for bronchiolitis without RSV diagnosis (3.3% vs 1.9%, P = .05). There were no significant differences by palivizumab administration status for the infants of 33 to 36 weeks' gestation.
Conclusions:
Among infants 29 to 32 weeks' gestation without chronic illness, palivizumab use was associated with reduced RSV hospitalizations but increased hospitalizations for bronchiolitis without RSV diagnosis.
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