title: Risk of new onset autoimmune disease in 9- to 25-year-old women exposed to human papillomavirus-16/18 AS04-adjuvanted vaccine in the United Kingdom.
abstract: To assess the risk of autoimmune disease (AD) in 9-25 year-old women within 1 year after the first AS04-HPV-16/18vaccine dose, a retrospective, observational database cohort study was conducted using CPRD GOLD. From CPRD GOLD 4 cohorts (65,000 subjects each) were retrieved: 1 exposed female cohort (received ≥1 AS04-HPV-16/18 vaccine dose between Sep2008-Aug2010) and 3 unexposed cohorts: historical female (Sep2005-Aug2007), concurrent male, and historical male. Co-primary endpoints were confirmed neuroinflammatory/ophthalmic AD and other AD, secondary endpoints were confirmed individual AD. Risk of new onset of AD was compared between cohorts (reference: historical cohort) using Poisson regression. The main analysis using confirmed cases showed no neuroinflammatory/ophthalmic AD cases in the female exposed cohort. Incidence rate ratio (IRR) (95% CI) of other AD was 1.41 (0.86 to 2.31) in female and 1.77 (0.94 to 3.35) in male cohorts when compared to the female and male historical cohort, respectively. Secondary endpoints were evaluated for diseases with >10 cases, which were Crohn's disease (IRR: 1.21 [0.37 to 3.95] for female and 4.22 [0.47 to 38.02] for male cohorts), autoimmune thyroiditis (IRR: 3.75 [1.25 to 11.31] for female and no confirmed cases for male cohorts) and type 1 diabetes (IRR: 0.30 [0.11 to 0.83] for female and 2.46 [1.08 to 5.60] for male cohorts). Analysis using confirmed and non-confirmed cases showed similar results, except for autoimmune thyroiditis in females, IRR: 1.45 (0.79 to 2.64). There was no evidence of an increased risk of AD in women aged 9 to 25 years after AS04-HPV-16/18 vaccination.
authors.affiliation: a Business & Decision Life Sciences on behalf of GSK Vaccines , Wavre , Belgium.
authors.forename: Corinne
authors.initials: C
authors.lastname: Willame
authors.affiliation: b GSK Vaccines , Wavre , Belgium.
authors.forename: Dominique
authors.initials: D
authors.lastname: Rosillon
authors.affiliation: b GSK Vaccines , Wavre , Belgium.
authors.forename: Julia
authors.initials: J
authors.lastname: Zima
authors.affiliation: b GSK Vaccines , Wavre , Belgium.
authors.forename: Maria-Genalin
authors.initials: MG
authors.lastname: Angelo
authors.affiliation: c Pallas Health Research and Consultancy , Rotterdam , the Netherlands.
authors.forename: Anke L
authors.initials: AL
authors.lastname: Stuurman
authors.affiliation: c Pallas Health Research and Consultancy , Rotterdam , the Netherlands.
authors.forename: Hilde
authors.initials: H
authors.lastname: Vroling
authors.affiliation: d CPRD Research Group , Victoria , London , UK.
authors.forename: Rachael
authors.initials: R
authors.lastname: Boggon
authors.affiliation: c Pallas Health Research and Consultancy , Rotterdam , the Netherlands.
authors.forename: Eveline M
authors.initials: EM
authors.lastname: Bunge
authors.affiliation: e RTI Health Solutions , Barcelona , Spain.|f Center for Health Policy and Health Services Research , Henry Ford Health System , Detroit , MI , USA.
authors.forename: Manel
authors.initials: M
authors.lastname: Pladevall-Vila
authors.affiliation: b GSK Vaccines , Wavre , Belgium.
authors.forename: Laurence
authors.initials: L
authors.lastname: Baril
mesh_terms: D000293:Adolescent; D000328:Adult; D000536:Aluminum Hydroxide / Q000008:administration & dosage / Q000009:adverse effects*; D001327:Autoimmune Diseases / Q000139:chemically induced* / Q000453:epidemiology*; D002648:Child; D005260:Female; D006801:Humans; D008050:Lipid A / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D053918:Papillomavirus Vaccines / Q000008:administration & dosage / Q000009:adverse effects*; D012189:Retrospective Studies; D018570:Risk Assessment; D006113:United Kingdom / Q000453:epidemiology; D055815:Young Adult
chemical_list: C532963:ASO4 mixture; D008050:Lipid A; D053918:Papillomavirus Vaccines; D000536:Aluminum Hydroxide
keywords: autoimmune conditions; human papilloma virus; human papillomavirus vaccine; post-licensure safety study; vaccination; vaccine safety