Expanding Uses of IVIG as Featured in IG Living Magazine
Below is an article written by Ilana Jacqueline featured in an issue of IG Living Magazine. (Sources can be seen at the full link at the bottom of this post.)
Researchers are taking a closer look at intravenous immune globulin for its potential to stop the progression of multiple complex conditions from lupus to multiple sclerosis.
The list of conditions that intravenous immunoglobulin (IVIG) may potentially treat has grown exponentially since its first use to treat primary immunodeficiency disease (PI) in 1952. It is known IVIG protects against infections, modulates the immune system and reduces inflammation, but it’s not entirely understood why it works, not only for diseases it is
Researchers are taking a closer look at intravenous immune globulin for its potential to stop the progression of multiple complex conditions from lupus to multiple sclerosis.
Worldwide, the total annual demand for plasma by pharmaceutical companies that manufacture plasma-based therapies is about 38 million liters. To meet this growing demand, most of the world’s plasma is collected in about 400 plasma donation centers scattered throughout the U.S., with some of it exported to other countries.
Once collected, plasma — 92 percent water and 8 percent proteins — must go through a fractionation process that separates and collects the indi-vidual proteins, of which 64 percent are albumin, 20 percent are immune globulin, 2.5 percent are alpha-1 antitrypsin, less than 1 percent are clotting factors, and 13.5 percent are others such as antithrombin, protein C, C1 esterase inhibitor, etc.
As part of the industry’s voluntary international standards program for manufacturers, known as the Quality Standards of Excellence, Assurance and Leadership(QSEAL), all plasma is held in inventory for 60 days before it can enter the manufacturing process. This allows for rigorous testing to identify, retrieve and destruct plasma donation from donors who are disqualified for various reasons such as having received a tattoo or piercing at the time of the original donation or failing to report foreign travel. Once the plasma is released from inventory, it is ready for fractionation. During the fractiona- tion process, plasma is pooled from multiple approved to treat, but for many others that have failed respond to conventional treatments.
To date, the U.S. Food and Drug Administration (FDA) has approved IVIG for only six indications: PI, idiopathic thombocytopenic purpura, multifocal motor neuropathy, B-cell chronic lymphocytic leukemia, Kawasaki disease and chronic inflammatory demyelinat-
ing polyneuropathy. And, while the most frequent pre- scribers of IVIG therapy have been immunologists, today, specialists in neurology, nephrology, rheumatology, dermatology and hematology have all found clinical uses for the treatment. As a matter of fact, it is believed, and in some instances medical evidence has shown, that IVIG may be beneficial for treating many off-label indications, which, according to past estimates, represent 50 percent to 80 percent of total IVIG use. These indications include a host of complex medical conditions, including lupus, multiple sclerosis (MS), Alzheimer’s disease, dysautonomia, infertility and many others.