Abstract
Objective Palivizumab is a humanized monoclonal antibody approved for the prevention of serious
lower respiratory tract infection (LRTI) caused by respiratory syncytial virus (RSV)
in infants and young children at high risk of RSV disease. This systematic review
summarized evidence on the effectiveness and safety of palivizumab when used in approved
populations.
Study Design A systematic review of Phase III trials and observational studies was conducted according
to the population, intervention, comparator, outcome, timing, setting (PICOTS) approach
(PROSPERO, CRD42021281380). Target populations consisted of infants with a history
of premature birth (≤35-week gestational age) and children aged <2 years with bronchopulmonary
dysplasia (BPD) or with hemodynamically significant congenital heart disease (hs-CHD).
Outcomes of interest included RSV-related hospitalization, admission to intensive
care unit (ICU), requirement for mechanical ventilation, treatment-related adverse
events (AEs), and RSV-related deaths. Information sources were literature search (Ovid
MEDLINE and Embase), pragmatic searches, and snowballing (covering the period up to
07 September 2021).
Results A total of 60 sources were included (5 Phase III trials and 55 observational studies).
RSV-related hospitalization rates following palivizumab prophylaxis in Phase III trials
were 1.8% in premature infants and 7.9% in children with BPD, which were significantly
lower than rates in placebo arms. In the real-world setting, similar hospitalization
rates were found (0.7–4.0% in premature infants [16 studies] and 0–5.5% in patients
with BPD [10 studies]) with ICU admission reported in 0 to 33.3% of patients hospitalized
for RSV. In Phase III trials, RSV-related mortality rates were 0.2 and 0.3%, while
AEs occurred in 11% of premature and/or BPD patients and 7.2% of hs-CHD patients,
consisting mainly of injection site reaction, fever, and diarrhea. Similar results
were found in observational studies.
Conclusion This systematic review supports the effectiveness and safety of palivizumab in the
indicated populations.
Key Points
Systematic review supports the positive benefit-risk profile of palivizumab in the
indicated populations.
Real-world safety and effectiveness of palivizumab are consistent with Phase III trials
results.
Palivizumab reduces RSV-related hospitalizations, ICU admissions, and need for mechanical
ventilation.
Keywords systematic review - respiratory syncytial virus - palivizumab - efficacy - effectiveness
- safety
