Abstract
Purpose Intravenous methylprednisolone (IVMP) pulse therapy is the first-line treatment in active moderate-to-severe Graves' orbitopathy (GO) and dysthyroid optic neuropathy (DON). One of the adverse effects of this therapy is liver dysfunction that can be mild (ALT < 100 U/L), moderate (ALT: 100–300 U/L), and severe defined as acute liver injury (ALI) (ALT > 300 U/L). ALI can be irreversible and fatal. The aim of the study was to evaluate the influence of two different schemes of therapy with IVMP in moderate-to-severe GO and DON on biochemical liver parameters. Materials and Methods 49 patients with moderate-to-severe GO were treated with IVMP in every week schedule (cumulative dose 4.5 g), and 19 patients with DON received 3.0 g IVMP (1.0 g/day for 3 consecutive days). AST, ALT, and total bilirubin were measured before treatment and after IVMP in the following selected pulses: after 0.5 g (A1), 3.0 g (A2), and 4.5 g (A3) in the group with moderate-to-severe GO and after 3.0 g IVMP in the group with DON (B1). Results We observed a statistically higher level of AST and ALT after therapy with 3.0 g of IVMP (B1) than after 0.5 g (A1), 3.0 g (A2), and 4.5 g of IVMP (A3). Mild elevation of ALT was found in 4% and 11% of patients with moderate-to-severe GO and DON, respectively. Moderate elevation of ALT was found in 0% and 21% of patients with moderate-to-severe GO and DON, respectively. There were no cases of ALI. Conclusion Therapy of GO with higher doses (1.0 g) of IVMP in consecutive days is associated with higher risk of liver damage than treatment with moderate doses (≤0.5 g) in every week schedule. This trial is registered with NCT03667157.
Highlights
Graves’ orbitopathy (GO) is a disorder characterized by orbital soft tissue inflammation and oedema associated with glycosaminoglycan deposition and fibrosis [1]
Serum autoantibodies associated with autoimmune hepatitis including anti-nuclear antibodies (ANA1), anti-smooth muscle antibodies (ASMA), anti-mitochondrial antibodies (AMA), and anti-liver kidney-microsomal antibodies were assessed
In 2 patients from the group with moderate-to-severe GO with a past medical history of viral hepatitis B, mild increases in ALT were observed before therapy, which later normalized during Intravenous methylprednisolone (IVMP) treatment
Summary
Graves’ orbitopathy (GO) is a disorder characterized by orbital soft tissue inflammation and oedema associated with glycosaminoglycan deposition and fibrosis [1]. Intravenous methylprednisolone (IVMP) pulse therapy is the first-line treatment in the active-phase of moderate-to-severe GO and DON [3]. The current recommendation of the European Group of Graves’ Orbitopathy (EUGOGO) is that cumulative doses of intravenous GCs should not exceed 8.0 g in each treatment course, and pulses should not be given on consecutive or alternate days, except in the case of DON [3]. This limitation is due to the necessity of the prevention of severe side effects that are rare but may be fatal. This study was performed to evaluate the influence of different schemes of therapy with IVMP in patients with moderate-to-severe GO and DON on biochemical liver parameters
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