Ann Haerskjold1,2, Marie Linder3, Lonny Henriksen4, Simon Francis Thomsen5, Helle Kieler3, Henrik Ravn6, Lone Graff Stensballe4. 1. The Child and Adolescent Clinic 4072, Copenhagen University Hospital Rigshospitalet, Copenhagen, Denmark. ann.haerskjold@gmail.com. 2. Department of Dermato-Allergology, Herlev and Gentofte Hospital, University of Copenhagen, Kildegaardsvej 28, Entrance 15, Hellerup, Denmark. ann.haerskjold@gmail.com. 3. Centre for Pharmacoepidemiology, Karolinska Institutet, Stockholm, Sweden. 4. The Child and Adolescent Clinic 4072, Copenhagen University Hospital Rigshospitalet, Copenhagen, Denmark. 5. Department of Dermatology, Bispebjerg University Hospital, Copenhagen, Denmark. 6. Coraxo Consulting, Copenhagen, Denmark.
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.
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.
Authors: Jonas F Ludvigsson; Eva Andersson; Anders Ekbom; Maria Feychting; Jeong-Lim Kim; Christina Reuterwall; Mona Heurgren; Petra Otterblad Olausson Journal: BMC Public Health Date: 2011-06-09 Impact factor: 3.295
Authors: Ann Haerskjold; Lonny Stokholm; Marie Linder; Simon Francis Thomsen; Gunnar Bergman; Ingegärd Anveden Berglind; Helle Kieler; Henrik Ravn; Lone Graff Stensballe Journal: Paediatr Drugs Date: 2017-04 Impact factor: 3.022
Authors: Sarah L N Clarke; Katie S Mageean; Ilaria Maccora; Sean Harrison; Gabriele Simonini; Gemma C Sharp; Caroline L Relton; Athimalaipet V Ramanan Journal: Rheumatology (Oxford) Date: 2022-02-02 Impact factor: 7.580