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Long term safety of IVIg therapy in multiple sclerosis: 10 years experience.
Autoimmunity. 2006 Sep;39(6):513-7.
Katz U, Kishner I, Magalashvili D, Shoenfeld Y, Achiron A.
Department
of Internal Medicine "B", Center for Autoimmune Diseases, The Chaim
Sheba Medical Center, Tel HaShomer, 52621, Israel.
Multiple
sclerosis (MS) is a chronic demyelinating disease of the central
nervous system. The majority of MS patients have a relapsing-remitting
course with progressive neurological disability that accumulates over
the years. Intravenous Immunoglobulin (IVIg) has demonstrated benefit
in the treatment of some patients with relapsing-remitting MS. Concerns
about adverse events of IVIg, mainly acute renal failure and
thromboembolic events have been raised in the medical literature.
We
examined the adverse events profile of IVIg treatment in a large cohort
of 293 relapsing-remitting MS patients treated with an initial loading
dose of IVIg (0.4 g/Kg body weight/day, for 5 consecutive days) and
additional booster dose infusions (0.4 g/Kg body weight/booster dose,
every 6 weeks) as a maintenance treatment. A total of 9281 IVIg
infusions were administered within a mean treatment period of 3.8 +/-
3.5 years (3 months-10 years). The main adverse event during the
loading dose period was headache, occurring in 12.6% of the patients.
The annual rate of any adverse event during the IVIg maintenance period
was 4.4% during the first year and had a trend to decrease with every
passing year of treatment. Adverse events during the loading dose did
not predict adverse events during the maintenance phase. No severe
adverse events were recorded. We conclude that IVIg is a safe therapy
in MS either for short or for long-term periods.
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