Dataset Information

73 Changes in Palivizumab usage in Canada 2005–2017 (Data from CARESS registry)

ABSTRACT: Abstract

Background

Palivizumabis a monoclonal antibody for preventionof serious lower respiratory tract infection caused by respiratory syncytial virus (RSV) in high risk children. Safety and efficacy were established in infants with bronchopulmonary dysplasia (BPD), prematurity (? 35 weeks gestational age), and hemodynamically significant congenital heart disease (CHD). The Canadian Registry of Palivizumab (CARESS) tracks palivizumab utilization in high-risk infants, whatever the indication. The decision to give palivizumab is by individual clinicians, not by the investigators, and is often for conditions not listed in the product monograph.

Objectives

To describe changes over time in indications for palivizumab prophylaxis in Canadian children using a Registry Database.

Design/Methods

A prospective, observational registry of infants from 32 sites who received ?1 dose of palivizumab during the 2005–2016 RSV seasons. Usage by indications is shown in two-year increments (Table 1), omitting 2016–17 when enrollment was limited; focused on those with complex medical disorders (CMD).Year*BPDPrematureCHDCMDTotaln%n%n%n%n2005–0716910.6117874.41499.4885.615842007–093449.3256069.33599.743411.736972009–114548.8326663.254010.590617.551662011–134888.3357261.171012.1107318.458432013–154528.8288656.164212.5116622.651472015–161717.9130360.321810.146921.72161Total20788.81476562.6261811.1413617.523598 *year defined as beginning of RSV season in one year to beginning of RSV season in the next year

Results

23,598 infants were enrolled, the overall indications for palivizumab were prematurity (62.6%), BPD (8.8%), CHD (11.1%), CMD (17.5%). Comparing groups across the 11 RSV seasons, the percentage with BPD was10.6–8.8%; prematurity decreased from 74.4% to 60.3% and CHD peaked at 12.5% from 2013–15. Palivizumab use in the CMD group rose from 5.6% to 22.6% (2013–15). Total n (%) with specific diagnoses were: Trisomy 21; 942 (21.2), Congenital airway anomalies; 855 (19.2), Neurological disorders; 471 (10.6), Cystic fibrosis; 442 (9.9) other pulmonary; 438 (9.8). The remainder comprised children with multiple indications, or individually less common diseases.

Conclusion

Caution is required in interpreting these data from a voluntary registry. Nevertheless the off label use of palivizumab in CMD has increased substantially. We suspect this reflects a desire of individual clinicians to protect “fragile” children whenever possible. Clinical Trial Registration: ClinicalTrials.gov NCT00420966

SUBMITTER: Mitchell I

PROVIDER: S-EPMC6543311 | biostudies-literature | 2019 May

REPOSITORIES: biostudies-literature

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Project description:Abstract Background The Canadian Registry of Palivizumab (CARESS) tracks palivizumab utilization and hospitalizations for respiratory illness (RI) and respiratory syncytial virus (RSVH) in high-risk infants, whatever the indication. The decision to administer palivizumab is taken by individual clinicians at the participating centers. Objectives To provide insight into the current management (utilization, adherence) with palivizumab of children at high risk of RSV infection in the tertiary care centers and community settings through the development of a Canadian Registry Database. A registry may give some indication of safety and effectiveness of an intervention in real life situations in many, uncommon medical conditions. Design/Methods A prospective, observational registry of infants from 32 sites who received ≥1 dose of palivizumab during the 2005–2017 RSV seasons. Palivizumab utilization and RI outcomes were collected monthly over each individual season. Results 25,003 infants were enrolled, the majority were male (56.3%) and Caucasian (68.6%). Subjects were, on average, 5.7 ± 6.4 months old at the time of enrolment, and had a mean gestational age of 32.6 ± 5.0 weeks. Of the children enrolled, indications for palivizumab were prematurity (≤ 35 weeks gestation, 63.3%), chronic lung disease (8.4%), significant congenital heart disease (10.5%), and other complex medical illnesses (17.8%). A total of 109,579 injections were given; average of 4 ± 1 injections per infant. Serious adverse events were uncommon. Adherence was measured in two ways. The number of actual injections compared with the expected and by this measure 83.8% received all of the expected injections. Adherence was also measured based on the length of the inter-injection interval, and by this measure 74.8% were adherent. Over the 12 seasons of CARESS, 1724 children were hospitalized a total of 2054 times. The overall RIH rate was 6.9%, the lowest being in preterm infants (4.3%). 1474 of 1724 children were tested for RSV;334 were RSV-positive. The cumulative RSVH rate was 1.6%. Conclusion The most common indications for palivizumab are prematurity, followed by those with medical complexity. Palivizumab is safe, and given that all of the infants are at high-risk for RSV, an adherence of 74.8% is not unreasonable. The low RSVH (1.6%) rate indicates that palivizumab is effective in the populations in which it is administered. Clinical Trial Registration: ClinicalTrials.gov NCT00420966

Project description:ObjectiveThis study aimed to evaluate palivizumab (PVZ) use, trends in indications, and outcomes of respiratory illness hospitalizations (RIH) and respiratory syncytial virus hospitalizations (RSVH).Study designIt involves a large, Canadian prospective (2005-2017) observational multicenter study of children at high risk for RSV infection.ResultsA total of 25,003 infants (56.3% male) were enrolled at 32 sites; 109,579 PVZ injections were administered. Indications included: prematurity (63.3%); "miscellaneous" (17.8%); hemodynamically significant congenital heart disease (10.5%); bronchopulmonary dysplasia/chronic lung disease (8.4%). The "miscellaneous" group increased over time (4.4% in 2005-2006 to 22.5% in 2016-2017) and included: trisomy 21, airway anomalies, pulmonary disorders, cystic fibrosis, neurological impairments, immunocompromised, cardiac aged >2 years, multiple conditions, and a residual "unclassified" group. Adherence measured by expected versus actual doses plus correct interdose interval was 64.7%. A total of 2,054 RIH occurred (6.9%); 198 (9.6%) required intubation. Three hundred thirty-seven hospitalized children were RSV-positive (overall RSVH 1.6%). Risk factors for RSVH included having siblings, attending daycare, family history of atopy, smoking exposure, and crowded household. Infants with 5 risk factors were 9.0 times (95% CI or confidence interval 4.4-18.2; p < 0.0005) more likely to have RSVH than infants without risk factors. Three adverse events occurred; none were fatal.ConclusionResults are relevant to both clinicians and decision-makers. We confirmed the safety of PVZ. Use of PVZ increased steadily for children with miscellaneous conditions and medical complexity. Medical and social factors pose a risk for severe RIH and RSVH with accompanying burden of illness. A vaccine that protects against RSV is urgently required.Key points· Main indications were prematurity (63.3%); "miscellaneous" (17.8%); hemodynamically significant congenital heart disease (10.5%); bronchopulmonary dysplasia/chronic lung disease (8.4%).. · The proportion of children in the "miscellaneous" group, comprised of those with trisomy 21, airway anomalies, pulmonary disorders, cystic fibrosis, neurological impairments, immunocompromised, cardiac aged >2 years, multiple conditions, and a residual "unclassified" group, increased over time (4.4% in 2005-2006 to 22.5% in 2016-2017).. · Respiratory illness-related hospitalization occurred in 2,054 children (6.9%); 198 (9.6%) required intubation. Three hundred thirty-seven hospitalized children were RSV-positive (overall RSVH: 1.6%)..

Project description:ImportanceAn important consequence of cannabis legalization is the potential increase in the number of cannabis-impaired drivers on roads, which may result in higher rates of traffic-related injuries and fatalities. To date, limited information about the effects of recreational cannabis laws (RCLs) on traffic fatalities is available.ObjectiveTo estimate the extent to which the implementation of RCLs is associated with traffic fatalities in Colorado and Washington State.Design, setting, and participantsThis ecological study used a synthetic control approach to examine the association between RCLs and changes in traffic fatalities in Colorado and Washington State in the post-RCL period (2014-2017). Traffic fatalities data were obtained from the Fatality Analysis Reporting System from January 1, 2005, to December 31, 2017. Data from Colorado and Washington State were compared with synthetic controls. Data were analyzed from January 1, 2005, to December 31, 2017.Main outcome(s) and measuresThe primary outcome was the rate of traffic fatalities. Sensitivity analyses were performed (1) excluding neighboring states, (2) excluding states without medical cannabis laws (MCLs), and (3) using the enactment date of RCLs to define pre-RCL and post-RCL periods instead of the effective date.ResultsImplementation of RCLs was associated with increases in traffic fatalities in Colorado but not in Washington State. The difference between Colorado and its synthetic control in the post-RCL period was 1.46 deaths per 1 billion vehicle miles traveled (VMT) per year (an estimated equivalent of 75 excess fatalities per year; probability = 0.047). The difference between Washington State and its synthetic control was 0.08 deaths per 1 billion VMT per year (probability = 0.674). Results were robust in most sensitivity analyses. The difference between Colorado and synthetic Colorado was 1.84 fatalities per 1 billion VMT per year (94 excess deaths per year; probability = 0.055) after excluding neighboring states and 2.16 fatalities per 1 billion VMT per year (111 excess deaths per year; probability = 0.063) after excluding states without MCLs. The effect was smaller when using the enactment date (24 excess deaths per year; probability = 0.116).Conclusions and relevanceThis study found evidence of an increase in traffic fatalities after the implementation of RCLs in Colorado but not in Washington State. Differences in how RCLs were implemented (eg, density of recreational cannabis stores), out-of-state cannabis tourism, and local factors may explain the different results. These findings highlight the importance of RCLs as a factor that may increase traffic fatalities and call for the identification of policies and enforcement strategies that can help prevent unintended consequences of cannabis legalization.