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. 2021 Mar;44(3):383-395.
doi: 10.1007/s40264-020-01031-1. Epub 2021 Jan 19.

Incidence Rates of Autoimmune Diseases in European Healthcare Databases: A Contribution of the ADVANCE Project

Corinne Willame  1 , Caitlin Dodd  2 , Lieke van der Aa  3 , Gino Picelli  4 , Hanne-Dorthe Emborg  5 , Johnny Kahlert  6 , Rosa Gini  7 , Consuelo Huerta  8 , Elisa Martín-Merino  8 , Chris McGee  9   10 , Simon de Lusignan  9   10 , Giuseppe Roberto  7 , Marco Villa  11 , Daniel Weibel  12   13 , Lina Titievsky  14 , Miriam C J M Sturkenboom  2   12   15
Affiliations

Incidence Rates of Autoimmune Diseases in European Healthcare Databases: A Contribution of the ADVANCE Project

Corinne Willame et al. Drug Saf. 2021 Mar.

Abstract

Introduction: The public-private ADVANCE collaboration developed and tested a system to generate evidence on vaccine benefits and risks using European electronic healthcare databases. In the safety of vaccines, background incidence rates are key to allow proper monitoring and assessment. The goals of this study were to compute age-, sex-, and calendar-year stratified incidence rates of nine autoimmune diseases in seven European healthcare databases from four countries and to assess validity by comparing with published data.

Methods: Event rates were calculated for the following outcomes: acute disseminated encephalomyelitis, Bell's palsy, Guillain-Barré syndrome, immune thrombocytopenia purpura, Kawasaki disease, optic neuritis, narcolepsy, systemic lupus erythematosus, and transverse myelitis. Cases were identified by diagnosis codes. Participating organizations/databases originated from Denmark, Italy, Spain, and the UK. The source population comprised all persons registered, with at least 1 year of data prior to the study start, or follow-up from birth. Stratified incidence rates were computed per database over the period 2003 to 2014.

Results: Between 2003 and 2014, 148,947 incident cases of nine autoimmune diseases were identified. Crude incidence rates were highest for Bell's palsy [23.8/100,000 person-years (PYs), 95% confidence interval (CI) 23.6-24.1] and lowest for Kawasaki disease (0.7/100,000 PYs, 95% CI 0.6-0.7). Specific patterns were observed by sex, age, calendar time, and data sources. Rates were comparable with published estimates.

Conclusion: A range of autoimmune events could be identified in the ADVANCE system. Estimation of rates indicated consistency across selected European healthcare databases, as well as consistency with US published data.

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Conflict of interest statement

At the time of the study and manuscript development, Corinne Willame worked part time with the GlaxoSmithKline (GSK) group of companies and declares not to receive any financial support from the GSK group of companies for the submitted work. At the time of the study and manuscript development, Lina Titievsky was a Pfizer employee. Rosa Gini is employed by ARS, a public health agency that conducts or participates in pharmacoepidemiology studies. The budget of ARS is partially sustained by such studies. Simon de Lusignan has been a member of Advisory Boards for Sanofi and Seqirus, and has received funding for vaccine-related researches from GSK, Seqirus, and Takeda. Daniel Weibel has been a consultant for GSK’s malaria vaccine program. Miriam Sturkenboom is principal investigator of post-authorization safety studies requested by the European Medicines Agency, for Novartis, none of which were related to the topic described. Caitlin Dodd, Lieke van der Aa, Gino Picelli, Hanne-Dorthe Emborg, Johnny Kahlert, Consuelo Huerta, Elisa Martín-Merino, Chris McGee, Giuseppe Roberto, and Marco Villa declare they have no conflicts of interest.

Figures

Fig. 1
Fig. 1
Incidence rates for narcolepsy in the AUH/SSI database, per age group and calendar year. IR incidence rate, PY person-years, CI confidence interval, AUH/SSI Aarhus University Hospital/Staten Serum Institute
See this image and copyright information in PMC

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References

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