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The following is a summary of “A Randomized Clinical Trial of Intravenous Methylprednisolone With 2 Protocols in Patients With Graves Orbitopathy,” published in the January 2024 issue of Endocrinology by Li, et al.

Intravenous glucocorticoid (IVGC) treatment is a widely accessible and cost-effective therapy for Graves orbitopathy (GO). While the 4.5-gram protocol is well-established, there is a need for further clarification on treatment protocols. For a study, researchers sought to compare the efficacy and safety of weekly and monthly IVGC protocols in treating GO.

The prospective, randomized, observer-masked, single-center clinical trial was conducted at the third affiliated hospital of Southern Medical University. Fifty-eight patients with active and moderate to severe GO, aged 18-60 years and not previously treated, were included. Patients received either a weekly or monthly protocol of IVGC, delivering a cumulative dose of methylprednisolone 4.5 g over a 12-week period. The overall effective rate, improvement in quality of life (QOL), and signal intensity ratio (SIR) were assessed.

There was no significant difference in the effective rate between the two groups at week 12 and week 24 (86.21% vs. 72.41%, P = .195; 86.21% vs. 82.61%, P = .441). Additionally, there was no significant difference in improving clinical activity score, exophthalmos, soft tissue involvement, diplopia, and QOL. Mean SIR and maximum SIR at week 24 were lower in both groups than pre-treatment levels, with no significant difference. The incidence of adverse events was comparable between the two groups (31.03% vs. 27.59%, P = .773).

Both weekly and monthly IVGC protocols demonstrated comparable efficacy and safety profiles. The monthly protocol could be an alternative to the weekly protocol for treating GO.

Reference: academic.oup.com/jcem/article-abstract/109/1/36/7242468