Dataset Information

72 Use of Palivizumab in Canada; Data from the CARESS registry 2005–2017

ABSTRACT: 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

SUBMITTER: Mitchell I

PROVIDER: S-EPMC6543371 | biostudies-literature | 2019 May

REPOSITORIES: biostudies-literature

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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