Safety profile of intravenous methylprednisolone therapy for thyroid eye disease: a multicenter retrospective study

To evaluate the safety profile of intravenous methylprednisolone (IVMP) in patients with thyroid eye disease (TED) and identify factors associated with major adverse events (AEs), focusing on age.

Multicenter retrospective study.

We reviewed 369 patients with active TED treated with IVMP. AEs occurring during or within 1 month of treatment were classified as mild, severe, or life-threatening. Logistic regression analyses identified factors associated with hyperglycemia, liver dysfunction, and severe/life-threatening AEs, with age-based comparisons (≥70 vs <70 years). For severe/life-threatening AEs, Firth's penalized logistic regression was additionally performed as a sensitivity analysis.

AEs occurred in 240 patients (65.0%); 231 (62.6%) were mild, and 15 (4.1%) were severe or life-threatening. Hyperglycemia and liver dysfunction occurred in 10.6% and 7.9%, respectively. In exploratory multivariable analyses, older age, diabetes mellitus, and high cumulative dose (>6000 mg) were associated with hyperglycemia. For severe/life-threatening AEs, older age was the most consistent associated factor in exploratory analyses, and this finding was unchanged in a sensitivity analysis using Firth's penalized logistic regression. Patients aged ≥70 years had significantly higher risks of both hyperglycemia and severe/life-threatening AEs.

IVMP for active TED is frequently associated with mild AEs, whereas severe or life-threatening events are uncommon but clinically important. Older age was the most consistent factor associated with severe/life-threatening AEs in exploratory analyses, and hyperglycemia risk was higher in older patients, patients with diabetes mellitus, and patients receiving higher cumulative doses. These findings support careful risk assessment and monitoring, particularly in elderly patients.