Bioscientia Medicina : Journal of Biomedicine and Translational Research
Vol. 9 No. 12 (2025): Bioscientia Medicina: Journal of Biomedicine & Translational Research

Balancing Efficacy and Tolerability: A Prospective Cohort Study of Oral and Intravenous Methylprednisolone for Active Graves' Ophthalmopathy in an Indonesian Tertiary Care Center

Mardijas Efendi (Unknown)
Hendriati (Unknown)
Pattih Primasakti (Unknown)
Yolanda Wulandari Erwen (Unknown)



Article Info

Publish Date
08 Oct 2025

Abstract

Background: In managing active, moderate-to-severe Graves' Ophthalmopathy (GO), a notable gap often exists between treatment efficacy in controlled trials and effectiveness in real-world practice. High-dose corticosteroids are standard, but the choice between intravenous (IV) and oral routes involves a complex trade-off between efficacy, tolerability, and practicality, particularly in diverse populations. Methods: This single-center, pragmatic, prospective cohort study was conducted at a tertiary hospital in Indonesia from March 2023 to March 2024. Thirty-six GO patients were treated with either IV pulse or daily oral methylprednisolone based on a shared clinical decision-making process. The primary outcome was the change in proptosis. To address the non-randomized design and control for selection bias, a propensity score-adjusted Analysis of Covariance (ANCOVA) was used to compare treatment effectiveness. Results: Baseline analysis revealed that patients selected for IV therapy had significantly more severe proptosis. Both unadjusted and adjusted analyses showed that each regimen resulted in a significant reduction in proptosis from baseline (p < 0.01). In the primary, propensity score-adjusted analysis, no statistically significant difference was detected in the degree of proptosis reduction between the IV and oral groups. However, the tolerability profiles were profoundly different; patients in the oral group experienced a significantly higher incidence of adverse events, including dyspepsia (66.7%) and Cushingoid features (55.6%), compared to a single case of transient hypokalemia in the IV group. Conclusion: In this real-world setting, after statistically controlling for baseline severity, both IV and oral methylprednisolone demonstrated comparable effectiveness in reducing proptosis. However, the intravenous route was associated with a vastly superior safety profile. These findings underscore the critical importance of tolerability in clinical decision-making and support the continued recommendation of IV pulse therapy as the first-line treatment.

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Journal Info

Abbrev

bsm

Publisher

Subject

Biochemistry, Genetics & Molecular Biology Immunology & microbiology Medicine & Pharmacology Neuroscience

Description

BioScientia Medicina is an open access international scholarly journal in the field of biomedicine and translational research aimed to publish a high-quality scientific paper including original research papers, reviews, short communication, and technical notes. This journal welcomes the submission ...