Demonstration of safety of intravenous immunoglobulin in geriatric patients in a long‐term, placebo‐controlled study of Alzheimer's disease

Alzheimer's and Dementia: Translational Research and Clinical Interventions - Tập 2 - Trang 131-139 - 2016
David Gelmont1, Ronald G. Thomas2, Jonathan Britt1, Jacqueline A. Dyck-Jones1, Jennifer Doralt3, Sandor Fritsch3, James B. Brewer2, Robert A. Rissman2, Paul Aisen4
1Clinical Development, Baxalta US Inc., Westlake Village, CA, USA
2ADCS Alzheimer's Disease Cooperative Study, UCSD, La Jolla, CA, USA
3Clinical Development, Baxalta Innovations GmbH, Vienna, Austria
4USC Alzheimer's Therapeutic Research Institute, San Diego, CA, USA

Tóm tắt

AbstractIntroductionWe present safety results from a study of Gammagard Liquid intravenous immunoglobulin (IGIV) in patients with probable Alzheimer's disease.MethodsThis was a placebo‐controlled double‐blind study. Subjects were randomized to 400 mg/kg (n = 127), 200 mg/kg (n = 135) IGIV, or to 0.25% human albumin (n = 121) administered every 2 weeks ± 7 days for 18 months.ResultsElevated risk ratios of IGIV versus placebo included chills (3.85) in 9.5% of IGIV‐treated subjects (all doses), compared to 2.5% of placebo‐treated subjects, and rash (3.08) in 15.3% of IGIV‐treated subjects versus 5.0% of subjects treated with placebo. Subjects in the highest IGIV dose group had the lowest proportion of SAEs considered related to product (2 of 127 [1.6%]). Subjects treated with IGIV experienced a lower rate of respiratory and all other infections compared to placebo.DiscussionIGIV‐treated subjects did not experience higher rates of renal failure, lung injury, or thrombotic events than the placebo group. There were no unexpected safety findings. IGIV was well tolerated throughout 18 months of treatment in subjects aged 50–89 years.

Tài liệu tham khảo

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Alzheimer's and Dementia: Translational Research and Clinical Interventions

Tập 2

131-139

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