title: Rates of autoimmune diseases in Kaiser Permanente for use in vaccine adverse event safety studies.
abstract: 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.
authors.affiliation: Kaiser Permanente Vaccine Study Center, Oakland, CA 94612, USA. Nicola.Klein@kp.org
authors.forename: Nicola P
authors.initials: NP
authors.lastname: Klein
authors.forename: Paula
authors.initials: P
authors.lastname: Ray
authors.forename: Diane
authors.initials: D
authors.lastname: Carpenter
authors.forename: John
authors.initials: J
authors.lastname: Hansen
authors.forename: Edwin
authors.initials: E
authors.lastname: Lewis
authors.forename: Bruce
authors.initials: B
authors.lastname: Fireman
authors.forename: Steven
authors.initials: S
authors.lastname: Black
authors.forename: Claudia
authors.initials: C
authors.lastname: Galindo
authors.forename: Johannes
authors.initials: J
authors.lastname: Schmidt
authors.forename: Roger
authors.initials: R
authors.lastname: Baxter
mesh_terms: 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
chemical_list: D014612:Vaccines