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Palivizumab Exposure and the Risk of Autoimmune Disease: A Cross-National Cohort Study

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Abstract

Background

Treatment with biologic pharmaceuticals may be associated with an increased risk of immune-mediated disease. Palivizumab is a humanized monoclonal antibody designed to provide passive immunity against respiratory syncytial virus infection. Palivizumab is primarily used in preterm children known to be immunologically immature. The long-term effect of palivizumab in terms of autoimmune diseases has not yet been investigated.

Aim

Our objective was to investigate whether exposure to palivizumab was associated with the development of autoimmune diseases in children.

Methods

This was a population-based cohort study including data from 769,523 Danish children born between 1 January 1999 and 31 December 2010 and data from 581,742 Swedish children born between 1 July 2005 and 31 December 2010.

Results

Of the 1,351,265 children included, 1192 (0.09 %) were exposed to palivizumab. Nine cases of autoimmune disease were diagnosed among palivizumab-exposed children during the period of observation. Among the children exposed to palivizumab, one child in Denmark developed inflammatory bowel disease; in Sweden, children developed juvenile arthritis (one child), diabetes mellitus (two children), celiac disease (four children), and inflammatory bowel disease (one child). The risk of autoimmune disease was not significantly increased after palivizumab exposure (hazard ratio adjusted for age and country: 1.54; 95 % confidence interval 0.80–2.95).

Conclusion

The risk of autoimmune disease was not increased after palivizumab exposure. Given the small number of incident cases of autoimmune disease observed, this finding should be interpreted with caution.

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Author contributions

LGS was responsible for the overall study and wrote the protocol together with HR and HK. HR supervised the statistical analyses of the Danish data and the combined Danish and Swedish data. ML was responsible for the statistical analyses in Sweden. AH collected data, participated in the data management and data analyses, and wrote the draft manuscript. SFT took part in the procedure to define the autoimmune diseases under study. LH performed data management in Denmark on the Danish data and the combined Danish and Swedish data. All authors read and approved the final manuscript.

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Authors and Affiliations

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

    Ann Haerskjold, Lonny Henriksen & Lone Graff Stensballe

  2. Department of Dermato-Allergology, Herlev and Gentofte Hospital, University of Copenhagen, Kildegaardsvej 28, Entrance 15, Hellerup, Denmark

    Ann Haerskjold

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

    Marie Linder & Helle Kieler

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

    Simon Francis Thomsen

  5. Coraxo Consulting, Copenhagen, Denmark

    Henrik Ravn

Authors
  1. Ann Haerskjold
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  2. Marie Linder
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  3. Lonny Henriksen
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  4. Simon Francis Thomsen
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  5. Helle Kieler
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  6. Henrik Ravn
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  7. Lone Graff Stensballe
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Corresponding author

Correspondence to Ann Haerskjold.

Ethics declarations

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

Funding

AbbVie provided a research grant to Karolinska Institute in Sweden and Rigshospitalet in Denmark. The wages of Ann Haerskjold, Lonny Henriksen, and Henrik Ravn were paid by a grant from AbbVie. Marie Linder, Simon Francis Thomsen, Helle Kieler, Lone Graff Stensballe have no financial relationships relevant to this article.

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Haerskjold, A., Linder, M., Henriksen, L. et al. Palivizumab Exposure and the Risk of Autoimmune Disease: A Cross-National Cohort Study. Pediatr Drugs 18, 435–441 (2016). https://doi.org/10.1007/s40272-016-0191-3

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  • DOI: https://doi.org/10.1007/s40272-016-0191-3

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