Fillit H, Hess G, Hill J, Bonnet P, Toso C
Alzheimer's Drug Discovery Foundation, New York, NY, USA.
Neurology. 2009 Jul 21;73(3):180-5. doi: 10.1212/WNL.0b013e3181ae7aaf.
To compare the incidence of Alzheimer disease and related disorders (ADRD) in patients treated with IV immunoglobulin (IVIg) for non-Alzheimer disease (AD) indications vs untreated controls.
This retrospective case-control analysis used medical claims for patients > or =65 years old from a national database of 20 million age-qualified patients. Cases received > or =1 IVIg administration during April 1, 2001-August 31, 2004, had claims 1 year prior to first (index) IVIg administration to confirm absence of pre-index ADRD, and had > or =3 years of continuous claims post-index. Untreated controls had their first medical claim during April 1, 2000-August 31, 2004, and otherwise met the same requirements as cases. Controls were matched 100:1 to cases on age, gender, and risk factors for ADRD. The relative incidence of ADRD post-index for the IVIg-treated cases vs untreated controls was estimated using Kaplan-Meier survival curves and a Cox proportional hazards model.
Treated patients in the Kaplan-Meier analysis had lower ADRD incidence (p = 0.02) with an estimated 2.6% of the 847 IVIg-treated vs 4.6% of 84,700 controls diagnosed with ADRD at 60 months after index date. Treated patients in the Cox proportional hazard model had a 42% lower risk of being diagnosed with ADRD (hazard ratio, 0.577; 95% confidence interval, 0.359 to 0.930; p = 0.024) with an estimated 2.8% of treated vs 4.8% of controls diagnosed with ADRD at 60 months after index date.
Previous treatment with IV immunoglobulin was associated with a reduced risk of developing Alzheimer disease and related disorders (ADRD) in this study. Evidence from additional studies is needed to evaluate the relationship between IVIg exposure and ADRD diagnosis.
比较接受静脉注射免疫球蛋白（IVIg）治疗非阿尔茨海默病（AD）适应证的患者与未治疗对照组中阿尔茨海默病及相关疾病（ADRD）的发病率。
这项回顾性病例对照分析使用了来自一个拥有2000万符合年龄条件患者的全国性数据库中65岁及以上患者的医疗索赔数据。病例在2001年4月1日至2004年8月31日期间接受了≥1次IVIg给药，在首次（索引）IVIg给药前有1年的索赔记录以确认索引前无ADRD，并在索引后有≥3年的连续索赔记录。未治疗的对照组在2000年4月1日至2004年8月31日期间有他们的首次医疗索赔记录，并且在其他方面满足与病例相同的要求。对照组在年龄、性别和ADRD风险因素方面与病例按100:1进行匹配。使用Kaplan-Meier生存曲线和Cox比例风险模型估计IVIg治疗病例与未治疗对照组索引后ADRD的相对发病率。
在Kaplan-Meier分析中，治疗患者的ADRD发病率较低（p = 0.02），在索引日期后60个月时，847例接受IVIg治疗的患者中有2.6%被诊断为ADRD，而84700例对照组中有4.6%被诊断为ADRD。在Cox比例风险模型中，治疗患者被诊断为ADRD的风险降低了42%（风险比，0.577；95%置信区间，0.359至0.930；p = 0.024），在索引日期后60个月时，估计治疗组中有2.8%被诊断为ADRD，而对照组中有4.8%被诊断为ADRD。
在本研究中，既往接受静脉注射免疫球蛋白治疗与发生阿尔茨海默病及相关疾病（ADRD）的风险降低相关。需要更多研究的证据来评估IVIg暴露与ADRD诊断之间的关系。
