By Jill Stein
CHICAGO -- APRIL 17, 2008 -- Intravenous (IV) immunoglobulin therapy has a favourable safety profile for patients with neuroimmunological disorders such as Guillain-Barré Syndrome, chronic inflammatory demyelinating polyneuropathy, myasthaenia gravis, polymyositis, dermatomyositis, and multifocal motor neuropathy, as reported here at the 60th Annual Meeting of the American Academy of Neurology (AAN 2008).
Patients with neuroimmunological disorders have limited therapeutic options, according to study presenter Zahid F. Cheema, MD, Staff Physician, Department of Neurology, St. Anthony's Medical Center, St. Louis, Missouri, and University of Oklahoma, Oklahoma City, Oklahoma, speaking here on April 15. "One widely accepted approach is the use of high-dose IV immunoglobulin therapy."
The term high-dose refers to the typical therapeutic dose used for patients with neuroimmunological disorders (<= 1-2 g/kg) versus that used for replacement therapy in primary immune deficiency (0.1-0.4 g/kg).
Dr. Cheema and colleagues evaluated the safety of 10% liquid IV immunoglobulin in patients with autoimmune neuromuscular disorders. The therapy was administered using a defined, supervised, outpatient clinical-management protocol. The trial included 70 patients with autoimmune neuromuscular disorders who received a total of 1,085 infusions of 10% liquid-formulation over a recent 9-month period.
The mean monthly dose of IV immunoglobulin was 1.6 g/kg, and the mean total induction dose was 2 g/kg. The mean daily infusion was 33.4 g/day, with a mean infusion rate of 93 ml/hour.
Safety assessments/adverse-event reporting was provided by a qualified nurse, who was present during all infusions studied.
The overall adverse-event rate for all infusions analysed was 4.7%. There were no serious adverse events, and the most common adverse events were mild and transient. Of 51 adverse events, just over half occurred in 5 patients.
"There continues to be controversy over whether high-dose IV immunoglobulin therapy is associated with an increase in the number or severity of adverse events over low-dose therapy," Dr. Cheema added. "Little specific data exist on [the use of] home-based therapeutic regimens in conjunction with new 10% liquid formulation products…that may be preferred over a lipophilised product or other liquid IV immunoglobulin."
"Overall, this review of liquid IV immunoglobulin infusions using a closely monitored, yet highly flexible, home-based therapeutic regimen indicated a very favourable tolerability profile in patients with neuroimmunological disorders -- even in those who were new to IV immunoglobulin therapy," Dr. Cheema said.
Funding for this study was provided by Baxter Healthcare Corporation.
[Presentation title: Safety of Intravenous Immune Globulin (IVIG) in the Home Setting in Patients With Autoimmune Neuromuscular Disorders. Abstract P02.124]
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