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Palivizumab for children with Down syndrome: is the time right for a universal recommendation?
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  • Published on:
    Palivizumab for children with Down syndrome: is the time right for a universal recommendation?
    • Bosco Paes, Neonatologist McMaster University
    • Other Contributors:
      • Souvik Mitra, Neonatologist

    We thank Drs Bok et al. for their comments on our recent editorial about the use of palivizumab in children with Down syndrome (DS).[1] However, most of their arguments are not pertinent to DS. First, they describe the general incidence of respiratory syncytial virus (RSV) in children aged <5years. Second, they discuss the efficacy of palivizumab based on the IMpact trial [2] that did not include children with DS. We provided concrete evidence from [3] metanalyses conducted in 1.1 million children with DS, that the risk of RSV-related hospitalisation (RSVH) is 6.1–8.7- fold higher than children without DS.1 Drs Bok et al. also fail to appreciate that the overall relative risk of RSVH without palivizumab, is 5.5-fold (95% CI 3.97 to 7.7) higher based on robust, high quality evidence.[3] In our previous study we also reported that for every 1000 children with DS with RSV there will be 200 more (95% CI,131-297) hospitalisations compared with 1000 children without DS with RSV (RR, 5.53; 95% CI,3.97-7.73; high GRADE).[4] Moreover, Drs Bok et al. have extrapolated the number needed to treat (NNT) with prophylaxis to prevent one RSVH in children with DS using sub-optimal data. In a prospective case-control, cohort study conducted in the Netherlands and Canada, the estimated NNT in children with DS, adjusted for confounding variables, is 12 and not 20.[5] This number also aligns with the report from the CARESS registry [6] and compares favourably with the NNT of 16 for preter...

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    Conflict of Interest:
    BP has received an investigator-initiated research grant from AbbVie Corporation and compensation as an advisor and speaker for AbbVie. SM has no conflicts to declare.
  • Published on:
    Palivizumab for children with Down syndrome: is the time right for a universal recommendation?
    • Levinus A Bok, Pediatrician PhD Máxima Medical Centre, Veldhoven, the Netherlands
    • Other Contributors:
      • Lonneke van Onzenorrt-Bokken, Pediatrician PhD
      • Johannes LP Kuijpens, MD PhD MPH

    In their editorial Paes and Mitra suggest that all patients with down syndrome (DS) <2 years should be considered to give palivizumab (Synagis®) to prevent respiratory syncytial virus (RSV) infection. We agree with the authors that DS children are at increased risk to develop RSV infections. However, we do not agree with their recommendation for palivizumab prevention in all DS children <2 years. In our opinion there is insufficient evidence on the efficiency and cost effectiveness and the recommendation is therefore premature.
    For the evaluation of preventive interventions the incidence and the absolute risk of acquiring the disease, and the effectiveness of the proposed intervention are important factors. The reported incidence of clinical relevant RSV infections in the general population in western countries is about 18/1,000 in newborns <2 months, 17/1,000 in children <6 months and 3/1,000 in children <5 years ( 2,3). Considering a relative extra risk of 5.5 in DS children (1) the calculated RSV incidence is 99/1,000 <2 months ( one out of 10) , 94/1,000 <6 months and 17/1,000 <5 years, respectively. The effectiveness of prevention of clinical treatment in premature children with palivizumab is about 50% (4). The extrapolated number needed to treat (NNT) for newborns with DS is 20 to prevent one hospitalization due to RSV infection. But what is the harm of this treatment as 19 out of 20 DS newborns will be given 114 injections per year...

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    Conflict of Interest:
    None declared.