PMID- 36452969
OWN - NLM
STAT- Publisher
LR  - 20240216
IS  - 1098-8785 (Electronic)
IS  - 0735-1631 (Linking)
DP  - 2023 Jan 18
TI  - Effectiveness and Safety of Palivizumab for the Prevention of Serious Lower 
      Respiratory Tract Infection Caused by Respiratory Syncytial Virus: A Systematic 
      Review.
LID - 10.1055/a-1990-2633 [doi]
AB  - 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..
CI  - The Author(s). This is an open access article published by Thieme under the terms 
      of the Creative Commons Attribution-NonDerivative-NonCommercial License, 
      permitting copying and reproduction so long as the original work is given 
      appropriate credit. Contents may not be used for commercial purposes, or adapted, 
      remixed, transformed or built upon. 
      (https://creativecommons.org/licenses/by-nc-nd/4.0/).
FAU - Gonzales, Tara
AU  - Gonzales T
AD  - SOBI Inc, Specialty Care North America, Waltham, Massachusetts.
FAU - Bergamasco, Aurore
AU  - Bergamasco A
AUID- ORCID: 0000-0001-8361-9746
AD  - YOLARX Consultants SAS, 101, rue de Sevres, Paris Cedex 6, France.
FAU - Cristarella, Tiffany
AU  - Cristarella T
AD  - YOLARX Consultants Inc, 3550 Cote-des-Neiges Road, Montreal, QC, Canada.
FAU - Goyer, Camille
AU  - Goyer C
AD  - YOLARX Consultants Inc, 3550 Cote-des-Neiges Road, Montreal, QC, Canada.
FAU - Wojdyla, Matthew
AU  - Wojdyla M
AD  - SOBI Inc, Specialty Care North America, Waltham, Massachusetts.
FAU - Oladapo, Abiola
AU  - Oladapo A
AD  - SOBI Inc, Specialty Care North America, Waltham, Massachusetts.
FAU - Sawicky, John
AU  - Sawicky J
AD  - SOBI Inc, Specialty Care North America, Waltham, Massachusetts.
FAU - Yee, John
AU  - Yee J
AD  - SOBI Inc, Specialty Care North America, Waltham, Massachusetts.
FAU - Moride, Yola
AU  - Moride Y
AD  - YOLARX Consultants SAS, 101, rue de Sevres, Paris Cedex 6, France.
LA  - eng
PT  - Journal Article
DEP - 20230118
PL  - United States
TA  - Am J Perinatol
JT  - American journal of perinatology
JID - 8405212
SB  - IM
COIS- A.B., T.C., C.G., and Y.M. are employees of YOLARX Consultants that received 
      funding from Sobi for the conduct of this review. T.G., A.O., J.S., J.Y., and 
      M.W. are employees of Sobi.
EDAT- 2022/12/02 06:00
MHDA- 2022/12/02 06:00
CRDT- 2022/12/01 02:55
PHST- 2022/12/02 06:00 [pubmed]
PHST- 2022/12/02 06:00 [medline]
PHST- 2022/12/01 02:55 [entrez]
AID - 10.1055/a-1990-2633 [doi]
PST - aheadofprint
SO  - Am J Perinatol. 2023 Jan 18. doi: 10.1055/a-1990-2633.