Dr. Abenhaim owns stock or stock options in, and is chairman of, LA-SER, an independent research organization that developed and owns the Pharmacoepidemiologic General Research eXtension (PGRx) database. LA-SER receives public and private funding, as well as funding from the pharmaceutical industry, including but not limited to AstraZeneca, Boiron, Expanscience, Genevrier, GlaxoSmithKline, Janssen-Cilag, Merck/Schering-Plough, Negma/Wokhardt, Novartis, Pfizer, and Sanofi. LA-SER has no commercial interests in any of the products studied.
Systemic Lupus Erythematosus
The Risk of Systemic Lupus Erythematosus Associated With Vaccines: An International Case-Control Study
Version of Record online: 27 MAY 2014
Copyright © 2014 by the American College of Rheumatology
Arthritis & Rheumatology
Volume 66, Issue 6, pages 1559–1567, June 2014
How to Cite
Grimaldi-Bensouda, L., Le Guern, V., Kone-Paut, I., Aubrun, E., Fain, O., Ruel, M., Machet, L., Viallard, J.-F., Magy-Bertrand, N., Daugas, E., Rossignol, M., Abenhaim, L., Costedoat-Chalumeau, N. and for the PGRx Lupus Study Group (2014), The Risk of Systemic Lupus Erythematosus Associated With Vaccines: An International Case-Control Study. Arthritis & Rheumatology, 66: 1559–1567. doi: 10.1002/art.38429
- Issue online: 27 MAY 2014
- Version of Record online: 27 MAY 2014
- Accepted manuscript online: 3 MAR 2014 10:54AM EST
- Manuscript Accepted: 13 FEB 2014
- Manuscript Received: 17 APR 2013
- INSERM research fellowship
Studies have suggested that systemic lupus erythematosus (SLE) may be triggered by vaccinations. We undertook this study to investigate the relationship between vaccination and onset of SLE.
This international case–control study was conducted between April 2008 and June 2012 in 36 specialist referral centers (34 in France and 2 in Quebec, Canada) and recruited patients ≤60 years old recently diagnosed as having either definite SLE (meeting ≥4 American College of Rheumatology [ACR] criteria including at least 1 immunologic criterion) or probable SLE (meeting 3 ACR criteria including at least 1 immunologic criterion). Controls were recruited from general practice settings through a closely monitored protocol and matched to patients by age, sex, region of residence, and date of recruitment. Vaccinations and other potential risk factors for SLE were assessed using a standardized telephone interview. We compared proportions of patients and controls who were vaccinated 12 and 24 months before the index date (date of first clinical symptom presented by the patient) using odds ratios (ORs) from conditional logistic regression.
We assessed 105 patients (89 with definite SLE and 16 with probable SLE) and 712 controls. Twenty-two of the 105 patients (21.0%) and 181 of the 712 controls (25.4%) had received at least 1 vaccination within 24 months before the index date (adjusted OR 0.9 [95% confidence interval 0.5–1.5]). The proportions of patients and controls vaccinated within the previous 12 months were also similar.
Our study showed no association between exposure to vaccination and risk of developing SLE.