We compared the effectiveness of systemic corticosteroids with the use
of high-dose intravenous immunoglobulin (IVIG) in the treatment of Gr
aves' ophthalmopathy. This was performed as a prospective, nonrandomiz
ed study including a blinded ophthalmological and orbital computed tom
ographic (CT) evaluation. The two groups of patients were not signific
antly different in relation to sex composition, age distribution, dura
tion of Graves' disease, and ophthalmopathy and previous hyperthyroidi
sm. All patients were followed up by endocrinologic evaluation and bli
nded 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 en
d of treatment for an average of 21 months (range 12 to 48 months). So
ft tissue involvement (NOSPECS) improved or disappeared in 32 of 35 (9
0%) patients treated with IVIG and in 25 of 27 (92.5%) patients treate
d 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 wer
e confirmed with orbital CT score in 30 IVIG patients and in the corti
costeroid-treated patients; a significant reduction of extraocular mus
cle thickness was observed after treatment in both groups. Proptosis i
mproved or disappeared in 20 of 31 (65%) patients treated with IVIG an
d in 15 of 24 (62%) patients treated with corticosteroids. Mean values
of proptosis evaluated by Hertel's exophthalmometer showed a slight r
eduction both in IVIG as well as in corticosteroid-treated patients. I
t is interesting to observe that in 28 IVIG-treated patients in whom i
t was possible to evaluate soft tissue involvement, proptosis and dipl
opia 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 corticost
eroid group 18 of 27 (66%) responded to treatment. The prevalences of
patients who responded to the treatments were not significantly differ
ent in the two groups (Chi-square). The initial values of the subjecti
ve eye score were similar in the two groups, and a significant reducti
on was observed in both. Major side effects requiring discontinuation
of the corticosteroid therapy were observed in two patients with hemor
rhagic gastritis and in one patient with manic-depressive psychosis. A
mong 15 patients submitted to the evaluation of bone mineral content b
efore and after corticosteroid therapy, 4 presented signs of osteoporo
sis and 3 a reduction of bone mineral content. Moderate and minor side
effects were more frequently noted in steroid-treated patients than i
n the IVIG group. These data suggest that IVIG is safe and effective i
n reducing the eye changes in patients with Graves' ophthalmopathy.