The authors noted that adverse event burden among different treatments will be compared in future studies to identify clinically meaningful AEU scores.
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They tested the validity of the AEU in measuring adverse event burden in MG in a single-center, prospective, 1-year, observational study in 54 adult patients with MG. The patients visited the hospital for their routine care between April 1, 2021, and March 31, 2022.
The researchers, led by Ted M. Burns, MD, from the University of Virginia in Charlottesville, Virginia, obtained the MG Activities of Daily Living (MG-ADL), the 15-item MG Quality of Life revised (MG-QOL15r), MG-Composite, and AEU scores of the patients at all visits.
Patients reported side effects during most (75%) of hospital visits. The researchers reported a weak correlation between AEU and MG-QOL15r scores.
They also found differences in median AEU scores among different treatments, but these differences were not statistically significant.
“Our data demonstrate preliminary feasibility and validity of using the AEU to measure side-effect burden among MG treatments,” the researchers concluded.
“Additional data are needed regarding the feasibility of AEU administration, comparative side-effect burden among MG treatments, and definition of a clinically meaningful difference in AEU scores in MG,” they added.
The AEU is a patient-weighted and physician-weighted consensus unit that quantifies and compares adverse event burdens among different drugs.
MG is a rare neurological disease affecting the neuromuscular junction. Many treatments are available for the disease, including cholinesterase inhibitors, corticosteroids, and immunosuppressants, but their long-term administration can cause adverse events such as opportunistic infections and lymphoproliferative disease.
This article originally appeared on Rare Disease Advisor
Hehir MK, Conaway M, St Sauveur AB, et al. Measuring treatment adverse event burden in myasthenia gravis: single-center prospective evaluation utilizing the adverse event unit (AEU). Muscle Nerve. Published online September 7, 2023. doi:10.1002/mus.27966