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High-Dose Intravenous ImmuneGlobulin for Stiff-Person Syndrome

All data were analyzed before the study code was broken, according to the linear model of Kenward and Jones. We extended this model to accommodate eight periods of analysis and obtain unbiased estimates of any base-line differences in the two groups during each treatment phase, the direct effects of treatment on symptoms during the month after each infusion, the residual effect after three monthly infusions (first-order carryover effect),and the residual effect after the washout period (second-order carry over effect), with use of least-square techniques. Significance testing was performed by applying permutation techniques that permute the data in all possible ways and determine a P value for each. The net differences in the stiffness index and heightened-sensitivity scores from base line to the end of three months of treatment and the first- or second-order carryover effects were compared between the treatment groups in each period. For the distribution of stiffness, a separate subanalysis of stiffness in the trunk, abdomen, arms, legs, and face was also performed.

We also conducted a sequential analysis of the two carryover effects(at an level of 0.05). We evaluated data for asecond-order carryover effect before evaluating whether there was afirst-order effect. Depending on the results of the sequentialtests, the model could include both carryover effects, only thefirst-order effect, or neither carryover effect. For example, if theP value for the model that included both carryover effects was notsignificant, the final model would not include any carryovereffects. The final model was ascertained on the basis of thetwo-sided P value for the two carryover effects and was used in theanalysis of the effects of treatment and base-line differencesbetween the two groups in each treatment period.

Results

Clinical Observations at Base Line

Of the 16 patients, 8 (4 women and 4 men) were randomly assigned toreceive placebo for the first three months and 8 (5 women and 3 men)were assigned to receive intravenous immune globulin first. The twogroups were similar with regard to age, duration of disease, age atonset of symptoms, severity of disease, and the prevalence of other autoimmune diseases .  
Complete results could not be obtained for two patients and thuswere never entered into the analysis. One man who was assigned toreceive intravenous immune globulin first had a severe, long-lasting, blisteringrash after each infusion that unmasked blinding. One woman who wasassigned to receive placebo first had an unusual pattern of motorbehavior with remarkable daily fluctuations that precluded datacollection.

Efficacy

In the group that received placebo first, the mean distribution-of-stiffnessscores did not change significantly during the three months ofplacebo administration but decreased significantly during the threemonths of immune globulin therapy (P=0.01) . In contrast, the scores in the group assigned toreceive immune globulin first dropped significantly (P=0.02) duringthe three months of immune globulin therapy, remained constantduring the washout period, and then increased during placeboadministration but did not return to base-line values. Thedifferences in scores between placebo and immune globulin weresignificant at months 3, 4, 5, 7, and 8 . When theoverall changes were compared between the two groups, immune globulintherapy was found to have a significant direct treatment effect(P=0.01) and first-order carryover effect (P<0.001). Subanalysesshowed that immune globulin therapy significantly reduced stiffnessof the trunk (P<0.001 for the direct treatment effect and P=0.04for the first-order carryover effect), abdomen (P<0.001 for thedirect treatment effect), and face (P<0.001 for the first-ordercarryover effect).

The time it took patients to walk 9.1 m decreased significantly inthe group that received immune globulin first, indicating reducedstiffness and spasms (P=0.02 for the direct and first-order effects;P=0.03 for the second-order carryover effect).

Clinical Observations during the First Three Months of Treatment

Six of seven patients who received immune globulin first were ableto walk more easily or without assistance for the first time inmonths or years . The frequency of falls decreased,and their fears about crossing open spaces diminished. They wereable to appear in public, socialize, cross a street without help,shower without spasms, and assume work-related or household chores.Their faces became animated. In contrast, no such objective changesoccurred during the first three months in the seven patients whoreceived placebo first.

Clinical Observations during the Second Three Months of Treatment

The condition of five of seven patients who received placebo firstimproved after they received immune globulin, and the condition offour of seven patients who received immune globulin first worsenedonce they began to receive placebo. The condition of one patient whoreceived placebo first worsened substantially during the threemonths of placebo treatment and was marked by continuous spasms andstiffness (status spasticus)3 by the timethe crossover phase began. The life-threatening nature of this stateprompted us to break the code. The patient's condition improveddramatically after he crossed over to immune globulin. Overall, 11patients had clinical improvement after receiving immune globulin,according to observations made before the study code was broken.

Patients' Own Assessments and Follow-up

Of 14 patients who were contacted after the results were analyzed (thespouses of 2 patients who died were contacted), 12 readily identifiedthe treatment phase on the basis of the unequivocal improvement intheir condition during that time. One patient, who received immuneglobulin first, had a slight improvement that was maintainedthroughout the study, presumably owing to a sustained carryovereffect, and could not distinguish one phase from the other. Thispatient did not wish to pursue further treatment with immuneglobulin. The other patient, who received placebo first, recalledhaving a gradual improvement throughout the study.

Two patients died after the study: one from gastrointestinal bleedinga year after the study and the other from cardiac arrest two yearsafter the study. Both had sought and received immune globulintherapy after the study. Of the other patients who successfullypursued continued immune globulin treatment, seven require infusionsevery 5 to 12 weeks and one other requires them every 4 months inorder to engage in routine daily activities. Two patients did notneed any additional treatment for up to a year. One patient wasunable to obtain approval for immune globulin therapy from theinsurance company.

Anti-GAD65 Antibody Titers

Anti-GAD65 antibody titers were measured in six patients in eachgroup. Anti-GAD65 antibody titers remained stable in patients who receivedplacebo first, whereas they decreased by 33 percent in patients whoreceived immune globulin first and then rebounded significantly (P=0.03) during placebo administration . Althoughafter the first three months, the difference in antibody titers was not significant between the two groups , thetiters were found to have declined significantly (P=0.05) afterimmune globulin therapy when the data for the second period werealso included and compared (data not shown). Weekly determinations ofantibodies in two patients showed that titers began to fall by theseventh day after the infusion and reached a nadir within threeweeks (data not shown). The anti-GAD65 antibody titers did not correlate with the severity of disease, and the reduction in titers was not correlated with the degree of improvement in the patients'clinical condition.

 
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