Willame Corinne, Rosillon Dominique, Zima Julia, Angelo Maria-Genalin, Stuurman Anke L, Vroling Hilde, Boggon Rachael, Bunge Eveline M, Pladevall-Vila Manel, Baril Laurence
a Business & Decision Life Sciences on behalf of GSK Vaccines , Wavre , Belgium.
b GSK Vaccines , Wavre , Belgium.
Hum Vaccin Immunother. 2016 Nov;12(11):2862-2871. doi: 10.1080/21645515.2016.1199308. Epub 2016 Jul 18.
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.
为评估9至25岁女性在首次接种AS04-HPV-16/18疫苗后1年内患自身免疫性疾病（AD）的风险，利用CPRD GOLD开展了一项回顾性观察数据库队列研究。从CPRD GOLD中检索出4个队列（每个队列65000名受试者）：1个暴露女性队列（在2008年9月至2010年8月期间接种了≥1剂AS04-HPV-16/18疫苗）和3个未暴露队列：历史女性队列（2005年9月至2007年8月）、同期男性队列和历史男性队列。共同主要终点为确诊的神经炎性/眼部AD和其他AD，次要终点为确诊的个体AD。使用泊松回归比较各队列（对照：历史队列）中AD新发风险。使用确诊病例的主要分析显示，暴露女性队列中无神经炎性/眼部AD病例。与女性和男性历史队列相比，女性队列中其他AD的发病率比（IRR）（95%CI）为1.41（0.86至2.31），男性队列中为1.77（0.94至3.35）。对病例数>10的疾病评估次要终点，这些疾病包括克罗恩病（女性队列IRR：1.21[0.37至3.95]，男性队列IRR：4.22[0.47至38.02]）、自身免疫性甲状腺炎（女性队列IRR：3.75[1.25至11.31]，男性队列无确诊病例）和1型糖尿病（女性队列IRR：0.30[0.11至0.83]，男性队列IRR：2.46[1.08至5.60]）。使用确诊和未确诊病例的分析显示了相似结果，但女性自身免疫性甲状腺炎除外，IRR：1.45（0.79至2.64）。没有证据表明9至25岁女性在接种AS04-HPV-16/18疫苗后患AD的风险增加。
