Original Title: État des connaissances: mise à jour de la revue systématique sur l’effet du palivizumab sur la diminution des complications associées au virus respiratoire syncytial chez les enfants

Authors' objectives: The Ministère de la Santé et des Services sociaux asked the Institut national d’excellence en santé et en services sociaux to reevaluate the criteria for administering palivizumab to children. This reevaluation will enable Héma-Québec to update its circular and the related forms for the next respiratory syncytial virus (RSV) infection season (2020-2021).

Authors' results and conclusions: RESULTS: No study on the effectiveness of palivizumab prophylaxis compared to the administration of placebo or no prophylaxis was identified for immunosuppressed children or children with a metabolic disorder or Down syndrome in a population consisting exclusively of premature infants with chronic lung disease of the newborn or bronchopulmonary dysplasia, or of children with a serious neuromuscular disorder affecting respiratory function, with upper airway abnormalities affecting respiratory function or from a healthy multiple birth whose twin was eligible for palivizumab. CONCLUSION: The new data support a protective effect of palivizumab on RSV hospitalizations, particularly in children born between 29 and 32 WG and those with hemodynamically significant congenital heart disease. In addition, recent studies appear to corroborate the effectiveness of palivizumab in preventing, in the short term, wheezing episodes in children born between 32 and 35 WG and between 33 and 35 WG. On the other hand, prophylaxis does not appear to have an impact on the development of asthma, regardless of the pediatric population considered (preterm infants, with or without underlying disease). However, given the limitations and the differences between the observational studies examined, further research with more robust designs (e.g., RCTs, meta-analysis) is required to confirm these findings. Some of the new data published point to a beneficial effect of palivizumab in children with cystic fibrosis, but further studies are needed to support this observation. The effectiveness of palivizumab in certain populations, including children with a chronic lung disease, interstitial lung disease or congenital diaphragmatic hernia and those living in remote communities, is too poorly documented to draw any definitive conclusions. In addition, the data are from studies with many methodological limitations. Lastly, unlike the systematic review published in 2016, no new studies were identified regarding the effectiveness of palivizumab prophylaxis compared to placebo or no prophylaxis in children with Down syndrome or who were included only in populations consisting exclusively of premature infants with chronic lung disease of the newborn or bronchopulmonary dysplasia.

Authors' methods: An update was carried out of the systematic literature review published by INESSS in 2016, which described the effectiveness of palivizumab administered prophylactically in reducing RSV-associated complications in children compared to the administration of placebo, to no prophylaxis or to another type of prophylaxis. The literature search was conducted in several databases, namely, MEDLINE (PubMed), Embase (Ovid), and the Cochrane Database of Systematic Reviews and Health Technology Assessment, and covered the period from January 2016 to April 2019. In addition, the bibliographies of the selected publications were examined. A grey literature search was conducted using the Google Scholar search engine. The effectiveness of palivizumab had to have been measured in terms of hospitalizations, the length of hospital stay, intensive care stays, the use of oxygen therapy (mechanical ventilation), long-term sequelae (wheezing or asthma) or mortality. The first and second selection of articles identified by the scientific data search were carried out independently by two scientific professionals. The data were extracted by one scientific professional and validated by another. The studies’ methodological quality was assessed using the Critical Appraisal Skills Programme (CASP) tool for randomized clinical trials (RCTs) and observational studies. The results were summarized in the form of an analytical narrative synthesis.

Project Status: Completed

URL for project: https://www.inesss.qc.ca/thematiques/medicaments/medicaments-evaluation-aux-fins-dinscription/avis-au-ministre.html#c4731

Year Published: 2020

URL for published report: https://www.inesss.qc.ca/thematiques/medicaments/medicaments-evaluation-aux-fins-dinscription/avis-au-ministre.html#c4731

Requestor: Minister of Health

English language abstract: An English language summary is available

Publication Type: Other

Country: Canada

Province: Quebec

Organisation Name: Institut national d'excellence en sante et en services sociaux

Contact Address: L'Institut national d'excellence en sante et en services sociaux (INESSS) , 2021, avenue Union, bureau 10.083, Montreal, Quebec, Canada, H3A 2S9;Tel: 1+514-873-2563, Fax: 1+514-873-1369

Contact Name: demande@inesss.qc.ca

Contact Email: demande@inesss.qc.ca

Copyright: Gouvernement du Québec