Efficacy and Safety of Three Different Cumulative Doses of Intravenous Methylprednisolone for Moderate to Severe and Active Graves' Orbitopathy

Abstract

The 7.47-g dose provides short-term advantages over lower doses. However, this benefit is transient and associated with slightly greater toxicity. The use of a cumulative dose of 7.47 g of methylprednisolone provides short-term advantage over lower doses. This may suggest that an intermediate-dose regimen be used in most cases and the high-dose regimen be reserved to most severe cases of GO.

Overall safety and efficacy of high-dose and low-dose intravenous glucocorticoid therapy in patients with moderate-to-severe active Graves’ ophthalmopathy

“…To the best of our knowledge, there were 2 randomized clinical trials investigating the optimal dose and schedule of iv GC therapy [16,17]. When Bartalena et al compared the safety and efficacy of 3 low-dose iv GC regimens (cumulative doses of 2.25 g, 4.98 g, and 7.47 g), they concluded that the higher-dose regimen provided a short-term advantage in efficacy, but had slightly greater toxicity [16]. In this study, although the HD group had slightly better changes in ophthalmic parameters and response rates, no statistically significant differences were detected in ophthalmic parameters or the safety profile between patients on the 2 regimens.…”

“…Since this is not a standard method for comparing SIRs from different MRI scanners, this approach requires further verification. We did not define the outcome of GO by evaluating a combination of changes in ophthalmic parameters because we were not able to collect complete information about ophthalmic parameters that were evaluated in prior large prospective studies [16,17]. For example, we were not able to obtain grades in each class of the NOSPECS classification from the patients' medical records.…”

THERAPY OF ENDOCRINE DISEASE: Endocrine dilemma: management of Graves’ orbitopathy

“…Treatment effectiveness much depends on interindividual variability, but this does not seem to be related to polymorphisms of the GC receptor (56). Intravenous pulsed methylprednisolone is more effective (14,46,57,61) and has a better safety profile compared with oral prednisone (60,61,62,63,64,65). Different treatment schedules have been used, with cumulative doses ranging from 4.5 to 12 g and occasionally associated with oral GC interpulse or at the end of the protocol (3,14,54,55,56,57,58,59).…”

“…Different treatment schedules have been used, with cumulative doses ranging from 4.5 to 12 g and occasionally associated with oral GC interpulse or at the end of the protocol (3,14,54,55,56,57,58,59). A recent multicenter randomized EUGOGO study has shown that a cumulative dose of 7.5 g of methylprednisolone is more effective than intermediate or lower doses (5 or 2.25 g respectively), although it is associated with more frequent adverse events (65). In particular, the high-dose regimen has a more significant and positive impact on eye muscle motility compared with lower doses.…”

“…The major limitation of GC therapy is that 20 -30% of patients are poorly responsive or unresponsive at all and that approximately 10 -20% of patients present with disease relapse after drug withdrawal (65). A recent retrospective study has shown that responsive patients usually have inactivation of GO as early as 6 -8 weeks from the beginning of GC therapy, whereas those who do not respond may be otherwise switched to other immunosuppressive treatments, alone or in combination with steroids (56).…”