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Palivizumab Exposure and the Risk of Atopic Dermatitis, Asthma and Allergic Rhinoconjunctivitis: A Cross-National, Population-Based Cohort Study

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Abstract

Background

Palivizumab is a humanized monoclonal antibody designed to provide passive immunity against respiratory syncytial virus. It is prescribed to children at high risk for severe infection with respiratory syncytial virus. However, little is known about the risk of the immune-mediated diseases atopic dermatitis, asthma, and allergic rhinoconjunctivitis after palivizumab exposure.

Aim

Our objective was to investigate whether exposure to palivizumab was associated with atopic dermatitis, asthma, or allergic rhinoconjunctivitis in childhood.

Methods

This was a cross-national population-based cohort study including data from 769,523 Danish children born 1 January 1999–31 December 2010 and 581,742 Swedish children born 1 July 2005–31 December 2010. Since palivizumab is only indicated for children at the highest risk, sub-cohorts of preterm children, children with bronchopulmonary dysplasia, and children with hemodynamic significant heart disease were defined.

Results

Of the 1,351,265 children included, 1192 (0.09%) were exposed to palivizumab. An increased risk of asthma after palivizumab exposure was observed in the total birth cohort (hazard ratio [HR] 1.49; 95% confidence interval [CI] 1.32–1.68) and in the sub-cohort of preterm children (HR 1.24; 95% CI 1.07–1.44). However, post hoc analyses using the propensity score to balance confounding factors found no increased risk of asthma in preterm children (HR 0.91; 95% CI 0.56–1.48). No increased risks of atopic dermatitis (HR 1.18; 95% CI 0.94–1.48) or allergic rhinoconjunctivitis (HR 1.14; 95% CI 0.92–1.42) were observed.

Conclusion

Exposure to palivizumab neither increased the risk of atopic disease nor protected against asthma.

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Author information

Authors and Affiliations

  1. The Child and Adolescent Clinic 4072, Copenhagen University Hospital Rigshospitalet, Copenhagen, Denmark

    Ann Haerskjold, Lonny Stokholm & Lone Graff Stensballe

  2. Department of Dermato-Allergology, Herlev and Gentofte Hospitals, University of Copenhagen, Hellerup, Copenhagen, Denmark

    Ann Haerskjold

  3. Centre for Pharmacoepidemiology, Karolinska Institutet, Stockholm, Sweden

    Marie Linder, Ingegärd Anveden Berglind & Helle Kieler

  4. Department of Dermatology, Bispebjerg University Hospital, Copenhagen, Denmark

    Simon Francis Thomsen

  5. Department of Women’s and Children’s Health, Karolinska Institutet, Stockholm, Sweden

    Gunnar Bergman

  6. Coraxo Consulting, Copenhagen, Denmark

    Henrik Ravn

Authors
  1. Ann Haerskjold
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Corresponding author

Correspondence to Ann Haerskjold.

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Funding

The study was an investigator-driven study funded by AbbVie. AbbVie provided a scientific review, but all decisions regarding the study design, the statistical analyses, and the manuscript were made by the authors.

Conflicts of interest

Abbvie provided a research grant to Karolinska Institute in Sweden and Rigshospitalet in Denmark. The wages of Ann Haerskjold, Lonny Stokholm, and Henrik Ravn were covered by a grant from Abbvie. Marie Linder, Simon Thomsen, Gunnar Bergmann, Ingegärd Berglind, Helle Kieler and Lone Stensballe have no financial relationships relevant to this article.

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Haerskjold, A., Stokholm, L., Linder, M. et al. Palivizumab Exposure and the Risk of Atopic Dermatitis, Asthma and Allergic Rhinoconjunctivitis: A Cross-National, Population-Based Cohort Study. Pediatr Drugs 19, 155–164 (2017). https://doi.org/10.1007/s40272-017-0215-7

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  • DOI: https://doi.org/10.1007/s40272-017-0215-7

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