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

Corinne Willame (), Caitlin Dodd, Lieke van der Aa, Gino Picelli, Hanne-Dorthe Emborg, Johnny Kahlert, Rosa Gini, Consuelo Huerta, Elisa Martín-Merino, Chris McGee, Simon Lusignan, Giuseppe Roberto, Marco Villa, Daniel Weibel, Lina Titievsky and Miriam C. J. M. Sturkenboom
Additional contact information
Corinne Willame: Julius Global Health, University Medical Center Utrecht
Caitlin Dodd: Julius Global Health, University Medical Center Utrecht
Lieke van der Aa: Sciensano
Gino Picelli: Epidemiological Information for Clinical Research from an Italian Network of Family Paediatricians (Pedianet)
Hanne-Dorthe Emborg: Statens Serum Institut
Johnny Kahlert: Aarhus University Hospital
Rosa Gini: Agenzia regionale di sanità della Toscana
Consuelo Huerta: Spanish Agency of Medicines and Medical Devices-AEMPS
Elisa Martín-Merino: Spanish Agency of Medicines and Medical Devices-AEMPS
Chris McGee: University of Surrey
Simon Lusignan: University of Surrey
Giuseppe Roberto: Agenzia regionale di sanità della Toscana
Marco Villa: Ospedale Val Padana
Daniel Weibel: VACCINE.GRID
Lina Titievsky: Pfizer
Miriam C. J. M. Sturkenboom: Julius Global Health, University Medical Center Utrecht

Drug Safety, 2021, vol. 44, issue 3, No 10, 383-395

Abstract: 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.

Date: 2021
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DOI: 10.1007/s40264-020-01031-1

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