576 - A Systematic Review on the Safety and Effectiveness of Palivizumab for the Prevention of Serious Lower Respiratory Tract Infection caused by Respiratory Syncytial Virus

Poster Number: 576
Publication Number: 576.417

Tara L. Gonzales, Sobi, NA, Pensacola, FL, United States; Aurore Bergamasco, YOLARX Consultants, Paris, Ile-de-France, France; Camille Goyer, YOLARX Consulants, Montreal, PQ, Canada; Matthew Wojdyla, Sobi, Mooresville, NC, United States; Abiola oladapo, Sobi, Waltham, MA, United States; Yola Moride, Rutgers New Jersey Medical School, New Brunswick, NJ, United States

Background:

Introduction: Respiratory syncytial virus (RSV) is a well-recognized cause of morbidity and mortality in children age ≤5 years. Palivizumab (SYNAGIS®) is a humanized monoclonal antibody for the prevention of lower respiratory tract infection (LRTI) caused by RSV in infants and young children at high risk of RSV disease.

Objective: This study analyzed evidence on safety and effectiveness of palivizumab used in approved populations (premature birth ≤35 weeks gestational age [WGA], children aged < 2 years with chronic lung disease [CLD] or bronchopulmonary dysplasia [BPD] or hemodynamically significant congenital heart disease [hs-CHD]).

Design/Methods: METHODS: A systematic review of Phase III trials and real-world studies was conducted. Information sources were literature search (Ovid® MEDLINE and Embase, 1998-Sept. 2021), pragmatic searches and snowballing. Study selection and data extraction were conducted independently by two assessors.

Results:

Results: Literature search yielded 2,250 references and snowballing found 3 additional studies. Eligibility was confirmed for 59 sources (5 trials and 54 observational studies). In phase III trials, rate of RSV-related hospitalization in palivizumab recipients was as low as 1.8% in premature infants and as high as 5.3% in young children with hs-CHD. In real-world studies on premature infants (≤35 WGA), rates ranged from 0.7%-3.7% (15 studies), with higher rates (5.0%-8.7%) observed in extremely premature infants (≤28 WGA). In CLD patients, rates ranged from 0%-5.4% (8 studies). Higher estimates were found for treated hs-CHD patients, from 2.1% to 12.2% (4 studies), depending on follow-up duration. In premature infants and CLD patients, palivizumab use significantly lowered RSV-related hospitalization rate (odds ratio [OR] range: 0.1 – 0.504). In 5 phase III trials, treatment-related adverse events (AEs) occurred in < 12% of patients. The most frequent AEs were injection site reaction, fever, and diarrhea, all occurring in < 3% of patients. In observational studies, frequency of AEs possibly related to palivizumab ranged from 0%-7% (5 studies). The most reported AEs were fever, rhinitis, and pain at injection site, all observed in < 2% of patients treated with palivizumab.Conclusion(s):

Conclusion: Findings from this systematic review support the effectiveness and safety of palivizumab as a prophylactic treatment to prevent RSV-related hospitalization in indicated populations.