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Submitted on January 24, 2005
Accepted on June 28, 2005
Depts. of Medicine I (GJK, MD), Biology (MD), Ophthalmology (SP), and Medical Statistics (GH), Gutenberg University, Mainz, Germany
* To whom correspondence should be addressed. E-mail: gkahaly{at}mail.uni-mainz.de.
Context Glucocorticoids are effective for severe Graves' orbitopathy (GO), which causes substantial morbidity. The question at issue is how best to use them
Objective Optimize glucocorticoid application in GO
Design Randomized trial over 12 weeks with six-month follow-up
Setting University joint thyroid and ophthalmic clinics
Patients Seventy euthyroid outpatients with untreated, active, and severe GO
Intervention Patients received either once weekly intravenous (IV) methylprednisolone (0.5 g, then 0.25 g, six weeks each) or oral prednisolone starting with 0.1 g/day, then tapering the dose by 0.01 g/week
Main outcome measures At three months the primary end point was a composite of improvements in proptosis, lid fissure width, and rate of diplopia in primary gaze, visual acuity, eye muscle thickness, and patient's quality of life.
Results IV glucocorticoid therapy resulted in rapid, significant and sustained improvement. At three months, 27/35 patients (77%) in the IV group had a treatment response, as compared with 18/35 (51%) in the oral group (P < 0.01). Improvements over baseline values for disease severity (e.g. visual acuity P = 0.01) and activity (e.g. chemosis P < 0.01), and for quality of life (P < 0.001) were greater in the IV group. TSH-R antibody titers decreased during IV steroid administration (P < 0.001), and smoking had a deep impact on the therapy response (P < 0.001). Additional treatment was required less frequently in the IV group. IV steroids were safe with differences in rates of adverse events between the two groups (P < 0.001).
Conclusions In patients with active and severe GO, IV glucocorticoids were more effective and better tolerated than oral steroids.
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