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From the Alzheimers Drug Discovery Foundation (H.F.), New York; Mount Sinai School of Medicine (H.F.), New York, NY; SDI (G.H., J.H.), Plymouth Meeting, PA; Leonard Davis Institute (G.H.), University of Pennsylvania, Philadelphia; Baxter Bioscience (P.B.), Westlake Village, CA; and Toso Clinical Communications (C.T.), Philadelphia, PA.
Address correspondence and reprint requests to Dr. Jerrold Hill, 220 W. Germantown Pike, Suite 140, Plymouth Meeting, PA 19462 jhill{at}sdihealth.com
Objective: 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.
Methods: This retrospective case-control analysis used medical claims for patients
65 years old from a national database of 20 million age-qualified patients. Cases received
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
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.
Results: 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.
Conclusions: 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.
Abbreviations: Aβ = amyloid beta; AD = Alzheimer disease; ADRD = Alzheimer disease and related disorders; DSM-IV = Diagnostic and Statistical Manual of Mental Disorders, 4th edition; ICD = International Classification of Diseases; IVIg = IV immunoglobulin.
Disclosure: Author disclosures are provided at the end of the article.
Received June 23, 2008. Accepted in final form April 10, 2009.
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