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. 2023 Oct 23;10(10):CD009417.
doi: 10.1002/14651858.CD009417.pub3.

Immunoglobulin treatment for hospitalised infants and young children with respiratory syncytial virus infection

Sharon L Sanders  1 , Sushil Agwan  2 , Mohamed Hassan  2 , Louis J Bont  3 , Roderick P Venekamp  4
Affiliations

Immunoglobulin treatment for hospitalised infants and young children with respiratory syncytial virus infection

Sharon L Sanders et al. Cochrane Database Syst Rev. .

Abstract

Background: Millions of children are hospitalised due to respiratory syncytial virus (RSV) infection every year. Treatment is supportive, and current therapies (e.g. inhaled bronchodilators, epinephrine, nebulised hypertonic saline, and corticosteroids) are ineffective or have limited effect. Respiratory syncytial virus immunoglobulin may be used prophylactically to prevent hospital admission from RSV-related illness. It may be considered for the treatment of established severe RSV infection or for treatment in an immunocompromised host, although it is not licensed for this purpose. It is unclear whether immunoglobulins improve outcomes when used as a treatment for established RSV infection in infants and young children admitted to hospital. This is an update of a review first published in 2019.

Objectives: To assess the effects of immunoglobulins for the treatment of RSV-proven lower respiratory tract infections (LRTIs) in children aged up to three years, admitted to hospital.

Search methods: For this 2022 update, we searched the Cochrane Central Register of Controlled Trials (CENTRAL), which contains the Cochrane Acute Respiratory Infections Specialised Register, Ovid MEDLINE, Embase, CINAHL, and Web of Science (from inception to 2 December 2022) with no restrictions. We searched two trial registries for ongoing trials (to 2 December 2022) and checked the reference lists of reviews and included articles for additional studies.

Selection criteria: Randomised controlled trials comparing immunoglobulins with placebo in hospitalised infants and children aged up to three years with laboratory-diagnosed RSV lower respiratory tract infection.

Data collection and analysis: Two review authors independently selected trials, assessed risk of bias, and extracted data. We assessed evidence certainty using GRADE.

Main results: In total, we included eight trials involving 906 infants and children aged up to three years. We included one new trial in this update. The immunoglobulin preparations used in these trials included anti-RSV immunoglobulin and the monoclonal antibody preparations palivizumab and motavizumab. Five trials were conducted at single or multiple sites within a single high-income country (four in the USA, one in Qatar). Three trials included study sites in different countries. All three of these trials included study sites in one or more high-income countries (USA, Chile, New Zealand, Australia, Qatar), with two trials also including a study site in a middle-income country (Panama). Five of the eight trials were "supported" or "sponsored" by the trial drug manufacturers. The evidence is very uncertain about the effect of immunoglobulins on mortality (risk ratio (RR) 0.87, 95% confidence interval (CI) 0.14 to 5.27; 4 studies, 309 participants). There were four deaths - two amongst 98 children receiving immunoglobulins, and two amongst 98 children receiving placebo. One additional death occurred in a fourth trial, however the study group of the child was not known and the data were not included in the analysis (very low-certainty evidence). The use of immunoglobulins in infants and children admitted to hospital with RSV proven LRTI probably results in little to no difference in the length of hospitalisation (mean difference (MD) -0.13 days, 95% CI -0.37 to 0.12; 6 studies, 737 participants; moderate-certainty evidence). Immunoglobulins may result in little to no difference in the number of children who experience one or more adverse events of any severity or seriousness compared to placebo (RR 1.18, 95% CI 0.78 to 1.78; 5 studies, 340 participants; low-certainty evidence) or the number of children who experience one or more adverse events judged by study investigators to be serious in nature, compared to placebo (RR 1.08, 95% CI 0.65 to 1.79; 4 studies, 238 participants; low-certainty evidence). Certainty of evidence for secondary outcomes was low. This evidence suggests that use of immunoglobulins results in little to no difference in the need for, or duration of, mechanical ventilation and the need for, or duration of, supplemental oxygen. The use of immunoglobulins does not reduce the need for admission to the intensive care unit (ICU) and when children are admitted to the ICU results in little to no difference in the duration of ICU stay.

Authors' conclusions: We are very uncertain about the effect of immunoglobulins on mortality. We are moderately certain that use of immunoglobulins in hospitalised infants and children may result in little to no difference in the length of hospitalisation. Immunoglobulins may result in little to no difference in adverse events, the need for or duration of mechanical ventilation, supplemental oxygen, or admission to the intensive care unit, though we are less certain about this evidence and the true effect of immunoglobulins on these outcomes may differ markedly from the estimated effect observed in this review. All trials were conducted in high-income countries, and data from populations in which the rate of death from RSV infection is higher are lacking.

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Conflict of interest statement

Sharon L Sanders: has declared that they have no conflict of interest. Sushil Agwan: has declared that they have no conflict of interest. Mohamed Hassan: has declared that they have no conflict of interest. Louis J Bont: has declared that they have the following interests: UMCU has received major funding (> EUR 100,000 per industrial partner) for investigator initiated studies from AbbVie, MedImmune, AstraZeneca, Sanofi, Janssen, Pfizer, MSD, and MeMed Diagnostics. UMCU has received major funding for the RSV GOLD study from the Bill and Melinda Gates Foundation. UMCU has received major funding as part of the public private partnership IMI‐funded RESCEU and PROMISE projects with partners GSK, Novavax, Janssen, AstraZeneca, Pfizer, and Sanofi. UMCU has received major funding by Julius Clinical for participating in clinical studies sponsored by MedImmune and Pfizer. UMCU received minor funding (EUR 1000 to 25,000 per industrial partner) for consultation and invited lectures by AbbVie, MedImmune, Ablynx, Bavaria Nordic, MabXience, GSK, Novavax, Pfizer, Moderna, AstraZeneca, MSD, Sanofi, and Janssen. Dr. Bont is the founding chairman of the ReSViNET Foundation. Roderick P Venekamp: has declared that they have no conflict of interest.

Figures

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Risk of bias graph: review authors' judgements about each risk of bias item presented as percentages across all included studies.
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Forest plot of comparison: Immunoglobulins versus placebo, outcome: 1.1 Mortality.
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Forest plot of comparison: Immunoglobulins versus placebo, outcome: 1.2 Length of hospitalisation (days).
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Forest plot of comparison: Immunoglobulins versus placebo, outcome: 1.3 Adverse events.
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Forest plot of comparison: Immunoglobulins versus placebo, outcome: 1.4 Serious adverse events.
1.1
1.1. Analysis
Comparison 1: Immunoglobulins versus placebo, Outcome 1: Mortality (any cause during hospitalisation or follow‐up)
1.2
1.2. Analysis
Comparison 1: Immunoglobulins versus placebo, Outcome 2: Length of hospitalisation (days)
1.3
1.3. Analysis
Comparison 1: Immunoglobulins versus placebo, Outcome 3: Adverse events of any severity or seriousness
1.4
1.4. Analysis
Comparison 1: Immunoglobulins versus placebo, Outcome 4: Serious adverse events
1.5
1.5. Analysis
Comparison 1: Immunoglobulins versus placebo, Outcome 5: Need for mechanical ventilation
1.6
1.6. Analysis
Comparison 1: Immunoglobulins versus placebo, Outcome 6: Duration of mechanical ventilation
1.7
1.7. Analysis
Comparison 1: Immunoglobulins versus placebo, Outcome 7: Need for supplemental oxygen
1.8
1.8. Analysis
Comparison 1: Immunoglobulins versus placebo, Outcome 8: Duration of supplemental oxygen
1.9
1.9. Analysis
Comparison 1: Immunoglobulins versus placebo, Outcome 9: Need for ICU admission
1.10
1.10. Analysis
Comparison 1: Immunoglobulins versus placebo, Outcome 10: Duration of stay in the ICU
See this image and copyright information in PMC

Update of

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