Dataset Information

Respiratory Syncytial Virus Immunoprophylaxis with Palivizumab: 12-Year Observational Study of Usage and Outcomes in Canada.

ABSTRACT:

Objective

This study aimed to evaluate palivizumab (PVZ) use, trends in indications, and outcomes of respiratory illness hospitalizations (RIH) and respiratory syncytial virus hospitalizations (RSVH).

Study design

It involves a large, Canadian prospective (2005-2017) observational multicenter study of children at high risk for RSV infection.

Results

A 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.

Conclusion

Results 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%)..

SUBMITTER: Mitchell I

PROVIDER: S-EPMC9643049 | biostudies-literature | 2022 Nov

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Respiratory Syncytial Virus Immunoprophylaxis with Palivizumab: 12-Year Observational Study of Usage and Outcomes in Canada.

Mitchell Ian I Li Abby A Bjornson Candice L CL Lanctot Krista L KL Paes Bosco A BA

American journal of perinatology 20210303 15

<h4>Objective</h4>This study aimed to evaluate palivizumab (PVZ) use, trends in indications, and outcomes of respiratory illness hospitalizations (RIH) and respiratory syncytial virus hospitalizations (RSVH).<h4>Study design</h4>It involves a large, Canadian prospective (2005-2017) observational multicenter study of children at high risk for RSV infection.<h4>Results</h4>A total of 25,003 infants (56.3% male) were enrolled at 32 sites; 109,579 PVZ injections were administered. Indications includ ...[more]

PMID: 33657636

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Project description:AbstractRespiratory syncytial virus (RSV) infection is an important cause of hospitalization in infants and young children. Monthly administration of palivizumab during the RSV season is effective in preventing severe infections in children with comorbidities. However, determining the onset of the RSV season for starting palivizumab is often challenging. The present study aimed to evaluate the ideal timing to start palivizumab and its effect on hospitalization in the real world.We performed a retrospective, observational study to identify the relationship between the timing of the first dose of palivizumab administration and RSV-related hospitalization. Medical records from 2015 to 2019 were reviewed. We included patients who had indications for palivizumab as of July 1 in each year. We counted the proportion of children receiving palivizumab and the number of RSV infection-related hospitalizations each month. We also evaluated the differences in background and underlying disease between children with and without hospitalization.A total of 498 patients were included, and 105 (21.0%) completed the first dose in July when the RSV season usually begins in Japan. Twenty-three (4.6%) patients were hospitalized for RSV infection during the observation period, with 13 (56.5%) hospitalizations before their first dose of palivizumab. The remaining 10 patients were hospitalized after receiving 1 or more doses of palivizumab. Children living with siblings and children with cyanosis originating from congenital heart disease had a higher risk of RSV with odds ratios of 5.1 (95% confidence interval 1.48-17.6, P < .01) and 3.3 (95% confidence interval 1.33-7.94, P < .01), respectively.Delays in administering palivizumab at the beginning of the season increases the rate of RSV infection-related hospitalization. To maximize prophylactic effectiveness, administering the first dose as early as possible in the RSV season is crucial, with priority for cyanotic children or those with siblings.

Project description: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

Project description:ImportanceInfection with the respiratory syncytial virus (RSV) is the leading cause of hospitalizations in children, accounting for more than 90,000 hospitalizations every year in the United States. For children who are at risk for severe RSV infections, the American Academy of Pediatrics recommends immunoprophylaxis with a series of up to 5 injections of the antibody palivizumab administered monthly, beginning on November 1 of each year. However, many practitioners initiate injections at the onset of RSV season as indicated by local surveillance.ObjectivesTo evaluate the effectiveness of current regimens for palivizumab injections across different cities and to design an optimized regimen.Design, setting, and participantsWe performed a mathematical modeling study of the risk for hospitalization due to RSV infection. The model accounted for the pharmacokinetics of the antibody, the timing of the injections, and seasonal patterns of RSV, including geographic and year-to-year variability. We used the model to estimate the efficacy of current regimens, including the American Academy of Pediatrics recommendation, and to design a more effective injection regimen, the optimized fixed start (OFS), which uses city-specific initiation dates. Participants were the approximately 700,000 individuals who had specimens tested for RSV by National Respiratory and Enteric Virus Surveillance System laboratories in 18 US cities from July 1, 1994, through June 30, 2011 (a total of 725,741 tests).InterventionsDifferent palivizumab injection regimens.Main outcomes and measuresThe primary outcome measure was reduction in hospitalizations due to RSV infections. The secondary measures were cost (number of palivizumab doses) and duration of protection (in days).ResultsThe American Academy of Pediatrics-recommended 5-injection regimen is expected to reduce hospitalization risk by a median of 2.7% (range, -2.2% to 6.1%) compared with the conventional regimen based on RSV surveillance. The 5-injection OFS regimen is expected to further reduce risk by a median of 6.8% (range, 4.9% to 14.8%), and the 4-injection OFS regimen is expected to achieve efficacy comparable to that of the conventional 5-injection regimen while reducing costs by 20%.Conclusions and relevanceModified palivizumab regimens can improve protection for children at risk for severe outcomes of RSV infection and thereby lower rates of hospitalization due to RSV.

Dataset Information

Respiratory Syncytial Virus Immunoprophylaxis with Palivizumab: 12-Year Observational Study of Usage and Outcomes in Canada.

Objective

Study design

Results

Conclusion

Key points

Publications

Respiratory Syncytial Virus Immunoprophylaxis with Palivizumab: 12-Year Observational Study of Usage and Outcomes in Canada.

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