The trial tests the hypothesis that, in adults with active, moderate-to-severe Graves' orbitopathy, 24 weeks of oral atorvastatin 20 mg daily added to a standard 12-week course of intravenous methylprednisolone produces a greater reduction in extraocular muscle size than intravenous methylprednisolone alone, and that any such reduction is accompanied by lower expression of TSH receptor, IGF-1 receptor, PDGF receptor, PI3K/AKT and miR-155 transcripts, and higher expression of miR-146a. The prespecified direction for miR-146a follows its reported suppression in CD4+ T cells in active disease \[26\]. Reported directions of change are compartment-specific and not unanimous, so the transcript analyses are exploratory.
Age 18 to 75 years inclusive
Graves' orbitopathy graded moderate-to-severe by EUGOGO criteria
Active disease, clinical activity score ≥ 3 of 7
Rehabilitative orbital decompression anticipated after completion of glucocorticoid therapy, on the usual clinical grounds
Sight-threatening disease at screening: dysthyroid optic neuropathy or corneal breakdown
Any other autoimmune disease requiring systemic immunosuppresion
Known hypersensitivity to atorvastatin or to any statin
Current or recent (within 3 months) use of any lipid-lowering drug
Parallel
Atorvastatin
DrugModerate-to-severe Graves' orbitopathy at a tertiary referral centre in Yogyakarta, Indonesia, will be allocated 1:1 to intravenous methylprednisolone (500 mg weekly for six weeks, then 250 mg weekly for six weeks) with oral atorvastatin 20 mg daily for 24 weeks.
methylprednisolone (IVMP)
DrugModerate-to-severe Graves' orbitopathy at a tertiary referral centre in Yogyakarta, Indonesia, will be allocated 1:1 to intravenous methylprednisolone (500 mg weekly for six weeks, then 250 mg weekly for six weeks)
Individual rectus muscle diameters
The primary outcome is measuring the rectus muscle diameters using Coronal CT, per muscle, both orbits
Composite ocular response
A participant is a responder if at least two of the five criteria below are met in the more affected eye, with no deterioration in any of them in either eye: 1. reduction in clinical activity score of 2 points or more; 2. reduction in proptosis of 2 mm or more, without an increase of 2 mm or more in the fellow eye; 3. reduction in vertical palpebral fissure height of 2 mm or more, with the same proviso for the fellow eye; 4. disappearance of diplopia, or improvement by at least one Gorman grade; 5. improvement in best-corrected visual acuity of 0.1 logMAR or more, this being the step on the logMAR chart closest to the 0.2-decimal criterion used in STAGO.
Clinical activity score
7-item EUGOGO scale, masked assessor Score : * Minimum score 0 and maximum score 7 at first meeting * Maximum score 10 at follow up meeting Higher score has worse outcome
Exophthalmos, clinical
Measurement of clinic exophthalmos using Hertel exophthalmometer, fixed base setting, single masked assessor
Exophthalmos, radiological
Exophthalmos measured from Interzygomatic line to posterior corneal surface, axial CT
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Banu Aji Dibyasakti
Lead sponsor
Gadjah Mada University
Sponsor institution
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