Safety of non-standard regimen of systemic steroid therapy in patients with Graves' orbitopathy: a single-centre experience

Pharmacol Rep. 2024 Feb;76(1):185-194. doi: 10.1007/s43440-023-00567-0. Epub 2024 Jan 26.

Abstract

Background: Graves' orbitopathy (GO) is an autoimmune disorder of the orbit and retro-ocular tissues and the primary extrathyroidal manifestation of Graves' disease. In moderate-to-severe and active GO iv glucocorticoids (GCs) are recommended as first-line treatment. The aim was to assess the safety profile of methylprednisolone administered intravenously for three consecutive days at 1 g in patients with active, moderate-to-severe or sight-threatening Graves' orbitopathy.

Methods: We retrospectively evaluated 161 medical records of patients with GO treated with high-dose systemic GCs in the Department of Endocrinology, Metabolic Disorders, and Internal Medicine in Poznań between 2014 and 2021. Clinical data included age, gender, laboratory results, activity and severity of GO, smoking status, disease duration, and presented side effects.

Results: The presence of mild side effects was observed during 114 (71%) hospitalizations. The most common complications were hyperglycemia (n = 95) and elevated aminotransferases (n = 31). Increased levels of aminotransferases were more likely observed in smokers and GO duration above 12 months. Based on the multivariate logistic regression, higher TRAb and CAS values were significantly associated with lower odds of hyperglycemia. In turn, the increased odds of elevated aminotransferases were significantly correlated with higher initial ALT levels, female gender, and GO duration above 12 months. In addition, the multidimensional correspondence analysis (MPA) showed that GO patients who declared smoking and had not L-ornithine L-aspartate applied demonstrated a higher probability of elevated aminotransferases.

Conclusions: Active GO treatment with high-dose systemic GCs is not associated with serious side effects. Hyperglycemia is the most common steroid-induced complication.

Keywords: Glucocorticoids; Graves’ orbitopathy; Hyperglycemia; Intravenous methylprednisolone; Side effects.

MeSH terms

  • Female
  • Glucocorticoids / adverse effects
  • Graves Disease* / complications
  • Graves Disease* / drug therapy
  • Graves Ophthalmopathy* / drug therapy
  • Graves Ophthalmopathy* / etiology
  • Humans
  • Hyperglycemia* / chemically induced
  • Hyperglycemia* / drug therapy
  • Methylprednisolone / adverse effects
  • Retrospective Studies
  • Transaminases

Substances

  • Glucocorticoids
  • Methylprednisolone
  • Transaminases