Clinical Advancements in Immunoglobulin Therapy
Immunoglobulin Therapy in Alzheimer's Disease
Data presented at the American Academy of Neurology April 10–17, 2010.
Alzheimer's disease patients treated with intravenous immunoglobulin (IVIg) for 18 months showed better cognitive function and less brain enlargement than those given placebo. After 18 months, patients with mild to moderate Alzheimer's disease who received the intravenous medication in a Phase II study averaged 1.36 points higher than patients who initially received a placebo on a test of mental abilities.
On a second cognitive performance test, patients who received IVIg declined by an average of 9.15 fewer points than placebo patients. MRI analyses also showed patients treated with IVIg saw a 6.7 percent decrease in annual ventricular enlargement in their brains, compared to a 12.3 percent rate in patients on a placebo.
The study involved 24 patients, with eight initially receiving placebo and 16 assigned to IVIg at doses ranging from 0.2 to 0.8 g/kg every two to four weeks. After 12 weeks, patients in the placebo group were re-randomized to IVIg at the same range of doses.
Patients were evaluated every three months during the 18-month study with the ADAS-Cog instrument and MRI scans. Their mean age at baseline was about 72. More than half were carriers of the apoE epsilon-4 allele that predisposes people to Alzheimer's disease.
The study reported strong correlations between the MRI measurements of ventricular enlargement and the CGIC and ADAS-Cog scores. Correlation coefficients (r2) were 0.27 and 0.41 for CGIC and ADAS-Cog, respectively, versus ventricular volume change (P=0.018 and 0.0041, respectively). Relative to whole brain volume change, the r2 values were 0.41 and 0.183 for CGIC and ADAS-Cog, respectively (P=0.0041 and 0.076, respectively). Neither baseline brain volumes nor ventricular volume predicted changes in these values during the study.
Projected Immunoglobulin Growth by Medical Specialty, Between 2009 and 2012
Immune-mediated neurological disorders will be the biggest driver of IVIg use over the next six years – driven by anticipated approvals for the treatment of Alzheimer's disease and Multifocal Motor Neuropathy.- Increased awareness associated with primary immune deficiency will increase demand for intravenous and subcutaneous immunoglobulin therapy.
- Restrictions that will tighten off-label use of immunoglobulin therapy will produce a decline in the areas of Dermatology, Obstetrics/Gynecology, Cardiology, and Ophthalmology





