We compared the effectiveness of systemic
corticosteroids with the use of high-dose
intravenous immunoglobulin (
IVIG) in the treatment of
Graves' ophthalmopathy. This was performed as a prospective, nonrandomized study including a blinded ophthalmological and orbital computed tomographic (CT) evaluation. The two groups of patients were not significantly different in relation to sex composition, age distribution, duration of
Graves' disease, and ophthalmopathy and previous
hyperthyroidism. All patients were followed up by endocrinologic evaluation and blinded ophthalmological (before
therapy = B, at the end of
therapy = E, and 6 months after the end = 6M) and orbital CT (B and E) evaluations. Twenty-seven patients treated with
IVIG were followed up after the end of treatment for an average of 21 months (range 12 to 48 months). Soft tissue involvement (NOSPECS) improved or disappeared in 32 of 35 (90%) patients treated with
IVIG and in 25 of 27 (92.5%) patients treated with
corticosteroids.
Diplopia improved or disappeared in 22 of 29 (75%) patients treated with
IVIG and in 16 of 20 (80%) patients treated with
corticosteroids. The results observed by clinical evaluation were confirmed with orbital CT score in 30
IVIG patients and in the
corticosteroid-treated patients; a significant reduction of extraocular muscle thickness was observed
after treatment in both groups.
Proptosis improved or disappeared in 20 of 31 (65%) patients treated with
IVIG and in 15 of 24 (62%) patients treated with
corticosteroids. Mean values of
proptosis evaluated by Hertel's exophthalmometer showed a slight reduction both in
IVIG as well as in
corticosteroid-treated patients. It is interesting to observe that in 28
IVIG-treated patients in whom it was possible to evaluate soft tissue involvement,
proptosis and
diplopia in the period between the fifth and sixth month from the start of
therapy, the most important part of the amelioration (if responders) was already obtained at that time. Responder patients were defined in relation to the decrease in the highest NOSPECS class or grade. Among
IVIG-treated patients 26 of 34 (76%) responded; while in the
corticosteroid group 18 of 27 (66%) responded to treatment. The prevalences of patients who responded to the treatments were not significantly different in the two groups (Chi-square). The initial values of the subjective eye score were similar in the two groups, and a significant reduction was observed in both. Major side effects requiring discontinuation of the
corticosteroid therapy were observed in two patients with hemorrhagic
gastritis and in one patient with
manic-depressive psychosis. Among 15 patients submitted to the evaluation of bone mineral content before and after corti-costeroid
therapy, 4 presented signs of
osteoporosis and 3 a reduction of bone mineral content. Moderate and minor side effects were more frequently noted in
steroid-treated patients than in the
IVIG group. These data suggest that
IVIG is safe and effective in reducing the eye changes in patients with
Graves' ophthalmopathy.