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


OBJECTIVE
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).


CONCLUSIONS
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.
The Child and Adolescent Clinic 4072, Copenhagen University Hospital Rigshospitalet, Copenhagen, Denmark. ann.haerskjold@gmail.com.|Department of Dermato-Allergology, Herlev and Gentofte Hospital, University of Copenhagen, Kildegaardsvej 28, Entrance 15, Hellerup, Denmark. ann.haerskjold@gmail.com.
Ann
A
Haerskjold
Centre for Pharmacoepidemiology, Karolinska Institutet, Stockholm, Sweden.
Marie
M
Linder
The Child and Adolescent Clinic 4072, Copenhagen University Hospital Rigshospitalet, Copenhagen, Denmark.
Lonny
L
Henriksen
Department of Dermatology, Bispebjerg University Hospital, Copenhagen, Denmark.
Simon Francis
SF
Thomsen
Centre for Pharmacoepidemiology, Karolinska Institutet, Stockholm, Sweden.
Helle
H
Kieler
Coraxo Consulting, Copenhagen, Denmark.
Henrik
H
Ravn
The Child and Adolescent Clinic 4072, Copenhagen University Hospital Rigshospitalet, Copenhagen, Denmark.
Lone Graff
LG
Stensballe
D000998:Antiviral Agents / Q000008:administration & dosage / Q000009:adverse effects*; D001327:Autoimmune Diseases / Q000453:epidemiology*; D002648:Child; D002675:Child, Preschool; D015331:Cohort Studies; D006801:Humans; D000069455:Palivizumab / Q000008:administration & dosage / Q000009:adverse effects*; D018357:Respiratory Syncytial Virus Infections / Q000517:prevention & control; D012306:Risk
D000998:Antiviral Agents; D000069455:Palivizumab
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