TY - JOUR

T1 - Palivizumab Exposure and the Risk of Autoimmune Disease

T2 - A Cross-National Cohort Study

AU - Haerskjold, Ann

AU - Linder, Marie

AU - Henriksen, Lonny

AU - Thomsen, Simon Francis

AU - Kieler, Helle

AU - Ravn, Henrik

AU - Stensballe, Lone Graff

PY - 2016/12

Y1 - 2016/12

N2 - 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.

AB - 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.

KW - Antiviral Agents

KW - Autoimmune Diseases

KW - Child

KW - Child, Preschool

KW - Cohort Studies

KW - Humans

KW - Palivizumab

KW - Respiratory Syncytial Virus Infections

KW - Risk

KW - Journal Article

U2 - 10.1007/s40272-016-0191-3

DO - 10.1007/s40272-016-0191-3

M3 - Journal article

C2 - 27665287

VL - 18

SP - 435

EP - 441

JO - Paediatric Drugs

JF - Paediatric Drugs

SN - 1174-5878

IS - 6

ER -