RESUMO
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..
RESUMO
In Canada, interventions and policies have been implemented to minimize the risk of opioid-related harms. This mixed methods study aimed at describing trends over time in implementation, as well as in awareness and health outcomes. For implementation, we conducted a scoping review to identify opioids interventions and policies implemented in Canada between 1 January 2016 and 15 November 2019. Awareness was measured through a descriptive analysis of opioid-related harm cases reported by consumers and health care professionals (HCPs) to the national spontaneous reporting system and of social media coverage, while health outcome consisted of opioid-related deaths recorded in the coroner's reports database of the province of Quebec, Canada. Trends over time in implementation of interventions were compared to trends in awareness and opioid-related deaths, without implying causality. There were 413 national or provincial interventions on opioids implemented over the study period, with a four-fold increase in 2016. The most common (31.5%) was harm reduction strategies, such as naloxone distribution. The reporting rate of opioid-related harms ranged between 0.1 and 0.2 per 100,000 persons with no observed time trend. Compared to 2015, the number of social media posts increased in 2016 by 35.4% (Reddit), 329.0% (Facebook), and 381.5% (Twitter). Between 2016 and 2019, there was a slight decrease in the number of opioid-related deaths recorded in the coroner's database. Overall, the increase in the number of policies did not see a parallel increase in spontaneous reports of opioid-related harms as an indicator of consumer or HCP awareness. Conversely, the dramatic increase in social media coverage was consistent with heightened public awareness. Although no inferences of causality were made in this study, the decrease in opioid-related deaths observed in the recent years may indicate a potential effectiveness of interventions and policies.
