Comparison of efficacy and safety of parenteral vs parenteral and oral glucocorticoid therapy in Graves' orbitopathy.

BACKGROUND/AIMS The most effective and safe treatment protocol for Graves'orbitopathy (GO) needs to be further assessed. The aim of the present study was to evaluate efficacy, safety and outcome of parenteral vs. parenteral and oral glucocorticoid (GC) protocols in euthyroid patients with untreated and active moderate to severe GO. METHODS This was a retrospective observational study in 140 patients comparing intravenous GC pulses only (IVGC group, 74 patients, 51±11 years) with historical controls of combined oral and intravenous GC therapy (CombGC group, 66 patients, 49±10 years, p=ns). IVGC therapy included infusions of 500mg of methylprednisolone weekly for the first six weeks, followed by infusions of 250mg weekly for the remaining six weeks (cumulative dose 4.5g). CombGC therapy included 500mg of methylprednisolone in 500ml of saline solution for two alternative days, followed by oral prednisone tapering dose repeated each month for the next 5 months (cumulative dose 10.2g). RESULTS The overall success of the treatment was 43/66 (65%) in CombGC group and 37/73 (51%, p=0.071) in IVGC group. Deterioration of GO developed in 4 (6%) patients during CombGC therapy, and in 9 (12%, p=0.214) patients during IVGC therapy. After 6 months, relapse of GO was observed in 10/37 (26%) in IVGC group, whereas none of patients in CombGC had relapse (p<0.001). There were significantly more side effects in CombGC vs. IVGC group (49/66, 74% vs. 28/74, 38%, p<0.001). CONCLUSIONS Our data suggest that CombGC therapy was more efficient with significantly less relapse rate, but with more side effects in comparison to IVGC therapy.