RANDOMIZED TRIAL OF INTRAVENOUS IMMUNOGLOBULINS VERSUS PREDNISOLONE IN GRAVES OPHTHALMOPATHY

Glucocorticoids are usually given for management of Graves' ophthalmop athy (GO), but they may cause side effects. By comparison, intravenous administration of immunoglobulins resulted in clinical improvement an d decreased antibody titres in a large number of autoimmune diseases. Therefore, a randomized trial was done, in which 19 patients with acti ve GO were treated with a 20-week course of oral prednisolone (P, star ting dose 100 mg/day), and 21 received 1 g immunoglobulin/kg body weig ht for 2 consecutive days every 3 weeks. The immunoglobulin course was repeated six times. Before and at the end (20 weeks) of immunomodulat ing therapy, ophthalmological investigation and quantitative magnetic resonance (MR) imaging were performed. A successful outcome was observ ed in 12 (63%) P- and in 13 (62%) immunoglobulin-treated patients. Ove rall, there were no marked differences in degree of improvement betwee n the two groups. Responders to treatment in both groups showed improv ements in proptosis (median from 24.5 to 21.5 mm; P < 0.005), visual a cuity (from 0.6 to 0.85; P < 0.001), intraocular pressure (from 25 to 20 mmHg; P < 0.0001), lid aperture (from 14 to 12 mm; P < 0.01) and a decrease in eye muscle area (inferior, from 44 to 33 mm(2) medial, fro m 43 to 34 mm(2); both P < 0.0005). Among the immunoglobulin-treated p atients, there was a marked decrease of thyroid antibody titres. Side effects were more frequent and severe during P than during immunoglobu lin therapy. Thus, with respect to the above mentioned objective param eters, P and immunoglobulin appeared to be equally effective in treatm ent of active GO.