Abstract
Purpose The intravenous glucocorticoid (iv GC) represents the mainstay of therapy for Graves' ophthalmopathy (GO), but uncertainty remains concerning the optimal regimen. Although the European Group on Graves' Orbitopathy (EUGOGO) regimen has been commonly employed, evidence for its superiority to other regimens is still lacking. The aim of this meta-analysis was to compare the efficacy and safety of the EUGOGO regimen with higher-dose regimens in the management of GO. Methods A systematic review and meta-analysis of randomized controlled trials (RCTs) and cohort studies comparing the EUGOGO regimen with higher-dose regimens was conducted. PubMed, Embase, and Web of Science databases were searched for relevant studies. The efficacy outcomes were response rate, change in clinical activity score (CAS), rate of proptosis improvement, and retreatment rate. The safety outcome was the incidence of adverse events. Results In the five included eligible trials, 136 participants in the EUGOGO regimen and 177 participants in higher-dose regimens were evaluated. Compared with the EUGOGO regimen, higher-dose regimens had no beneficial effect on the response rate, change of CAS, rate of proptosis improvement, and retreatment rate (OR: 1.3; 95% CI: 0.36–4.65; SMD: –0.04; 95% CI: –0.54, 0.45; OR: 0.79; 95% CI: 0.44–1.44; OR: 0.87; 95% CI: 0.27–2.77). For the incidence of adverse events, the results also showed no significant difference between the 2 groups (OR: 1.14; 95% CI: 0.62–2.09). Conclusion The current evidence showed that the efficacy of the EUGOGO regimen was comparable with higher-dose regimens. Since there was no significant difference in the incidence of adverse events between the two regimens, appropriate selection of patients and careful monitoring were required in both regimens. More well-designed, large-scale, and longer follow-up period studies were needed to further verify the finding of this analysis.
Highlights
Graves’ ophthalmopathy (GO) is an orbital autoimmune disorder [1], which is characterized by periorbital edema, restrictive strabismus, and proptosis [2]. is disease has a relatively high incidence and remains one of the most challenging diseases to manage owing to its complex and poorly understood pathogenesis [3, 4]
All participants were rated with the severity moderate to severe; the mean age was from 41.8 to 46.8 years. e single doses were among 0.25 g to 1 g, cumulative doses ranged from 4.5 g to 18 g, dosing interval ranged from 1 week to 4 weeks, and treatment course ranged from 4 weeks to 24 weeks. e mean follow-up ranged from 11 weeks to 24 weeks
Our study found no significant difference of the rate of proptosis improvement between the two regimens. e underlying mechanism is yet to be completely elucidated; it might be that the patient’s orbital remodeling and eventual fibrosis occur very early in the course of the disease, so there is no hope that whatsoever medical treatment be effective if these changes have taken place [28]
Summary
Graves’ ophthalmopathy (GO) is an orbital autoimmune disorder [1], which is characterized by periorbital edema, restrictive strabismus, and proptosis [2]. is disease has a relatively high incidence and remains one of the most challenging diseases to manage owing to its complex and poorly understood pathogenesis [3, 4]. Is disease has a relatively high incidence and remains one of the most challenging diseases to manage owing to its complex and poorly understood pathogenesis [3, 4]. Physicians and scientists continue their efforts to optimize treatment recommendations [5], most treatments for active, moderateto-severe GO remain suboptimal [6]. Several studies have demonstrated the effectiveness of glucocorticoids in GO treatment [7, 8], but the regimen of glucocorticoid, ranging from the drug dosage and the administration route to the course of treatment, varied among different studies. The commonest and recommended regimen is a 4.5 g cumulative dose subdivided into 12 weekly infusions (EUGOGO regimen) [9]. In terms of its efficacy, the results showed that about 20–30% of patients were unresponsive or poorly
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