Rates of autoimmune diseases in Kaiser Permanente for use in vaccine adverse event safety studies.
Safety monitoring following new vaccine introduction includes assessment of potential new onset autoimmune diseases (AID). As knowledge regarding AID background rates is limited, we evaluated the incidence of 11 AID in Northern California Kaiser Permanente. AID cases were identified using electronic records of members aged 10-62 years from 1998 to 2004, excluding those with AID diagnoses from 1996 to 1997. Using prespecified criteria, all identified cases of rare diseases were verified by medical record review, while a sample of cases was reviewed for common diseases; incidence rates were calculated based on the proportion of confirmed cases. Overall, the incidence of AID varied from 0.8/100,000 person-years (PY) for autoimmune hemolytic anemia (AIHA) to 54.1/100,000 PY for thyroiditis. Incidence rates in increasing order were AIHA, juvenile rheumatoid arthritis, Guillain-Barre Syndrome, idiopathic thromobocytopenia purpura, transverse myelitis, systemic lupus erythematosus, uveitis, multiple sclerosis, rheumatoid arthritis, Type 1 diabetes mellitus and thyroiditis; incidence rates also varied according to age and gender. These background incidence rates should prove useful for future observational vaccine safety studies and will help guide evaluation of potential vaccine AID events following introduction of new vaccines.
Klein
Nicola P
NP
Kaiser Permanente Vaccine Study Center, Oakland, CA 94612, USA. Nicola.Klein@kp.org
Ray
Paula
P
Carpenter
Diane
D
Hansen
John
J
Lewis
Edwin
E
Fireman
Bruce
B
Black
Steven
S
Galindo
Claudia
C
Schmidt
Johannes
J
Baxter
Roger
R
D000293:Adolescent; D000328:Adult; D001327:Autoimmune Diseases / Q000453:epidemiology*; D002140:California; D002648:Child; D003625:Data Collection / Q000379:methods; D006801:Humans; D015994:Incidence; D007348:Insurance, Health; D008297:Male; D008499:Medical Records; D008875:Middle Aged; D014612:Vaccines / Q000009:adverse effects*; D055815:Young Adult
D014612:Vaccines