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High-Dose Intravenous ImmuneGlobulin for Stiff-Person Syndrome

Marinos C. Dalakas,M.D., Mavis Fujii, M.D., Mian Li, M.D., Bashar Lutfi, M.D., Joan Kyhos, B.S.N.,and Beverly McElroy, C.N.R.N.


Background Stiff-person syndrome is a disabling central nervous system disorder with no satisfactory treatment that is characterized by muscle rigidity, episodic muscle spasms, high titers of antibodies against glutamic acid decarboxylase (GAD65), and a frequent association with autoimmune disorders. Because stiff-person syndrome is most likely immune-mediated, we evaluated the efficacy of intravenous immune globulin.

Methods We assigned 16 patients who had stiff-person syndrome and anti-GAD65 antibodies, in random order, to receive intravenous immuneglobulin or placebo for three months

Results Among patients who received immune globulin first, stiffness scores decreased significantly (P=0.02) and heightened-sensitivity scores decreased substantially during immuneglobulin therapy but rebounded during placebo administration. Eleven patients who received immune globulin became able to walk more easily or without assistance, their frequency of falls decreased, and they were able to perform work-related or household tasks. The duration of the beneficial effects of immune globulin varied from six weeks to one year. Anti-GAD65 antibody titers declined after immune globulin therapy but not after placebo administration.

Conclusions Intravenous immune globulin is a well-tolerated and effective, albeit costly, therapy for patients with stiff-person syndrome and anti-GAD65 antibodies.

Stiff-person syndrome is a rare central nervous system disorder characterized by rigidity of truncal and proximal limb muscles with intermittent superimposed spasms. Continuous contractions of agonist andantagonist muscles caused by the involuntary firing of motor units at rest are the clinical and electrophysiologic hallmarks of the disease. The cause of stiff-person syndrome is autoimmune pathogenesis is suspected for several reasons. Circulating antibodies against glutamic acid decarboxylase(GAD65) are characteristic of the disease and have distinct epitope specificity.These antibodies are produced intrathecally and may be pathogenic because they inhibit the activity and may impair the synthesis of the inhibitory neurotransmitter-aminobutyric acid (GABA), resulting in low levels of GABA in the brain and cerebrospinal fluid. Stiff-person syndrome is frequently found in association with other autoimmune disorders, autoantibodies, and certain HLA-DR and DQ phenotypes



From 1996 to 1999, we enrolled 16 patients with stiff-person syndrome(9 women and 7 men) who ranged in age from 28 to 59 years (mean age,46). All patients had had incomplete responses to therapies andfulfilled the following strictly defined clinical criteria: rigidity of limb and axial (trunk) muscles that was prominent in the abdominal and thoracolumbar paraspinal areas and made bending difficult; clinical and electrophysiological evidence of continuous contraction of agonist and antagonist muscle; episodic spasms precipitated by unexpected noises, tactile stimuli, or emotional upset; the absence of any other neurologic disease that could explain the stiffness andrigidity; and anti-GAD65 antibodies, as assessed by immunocytochemical analysis,

Study Design

The protocol specified the intravenous administration of 2g of immune globulin per kilogram of body weight per month, divided into two consecutive daily doses of 1 g per kilogram,or placebo, consisting of half-normal saline, once a month for threemonths in random order, followed by a one-month washout period and three months of treatment with the alternative agent. Immuneglobulin costs $75 to $80 per gram. Thus, for a patient who weighed70 kg, the cost of the drug would be at least $10,500 per month or$31,500 for the full three-month course of treatment.

Measurement of Anti-GAD65 Antibody Titers

Anti-GAD65 antibody titers were measured by ELISAin coded specimens obtained before and after each three-monthtreatment period. Twelve patients had preinfusion and postinfusionserum samples from both phases of the study.

Statistical Analysis

The primary end point was a change in the scores of thedistribution-of-stiffness index and the heightened sensitivity scalefrom base line (month 1) to the second and third month of eachtreatment. Secondary end points were changes in the patients'ability to bend at the waist, expand their chests, and perform timedactivities, such as walking 9.1 m (30 ft)Student's t-test was used to assess differences in anti-GAD65antibody titers before and at the end of each three-month treatmentperiod.

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