Cutoffs on severity metrics for minimal manifestations or better status in patients with generalized myasthenia gravis

International consensus guidance and Japanese clinical guidelines for myasthenia gravis (MG) recommend achieving minimal manifestations or better status (MM-or-better) as the severity component of the treatment goal. However, the subjective nature of determining MM can result in ambiguity regarding this category in clinical practice and clinical trials. This study analyzed severity metrics in a large number of MG patients to propose criteria for MM-or-better. We utilized data obtained from 3800 MG patients who participated in nationwide cross-sectional surveys in Japan. Among these, 2784 patients with generalized MG were divided into two groups based on MG Foundation of America postintervention status: MM-or-better status (n = 1432); and improved-or-worse (I-or-worse) status (n = 1352). We compared severity metrics (MG-activities of daily living scale [MG-ADL], quantitative MG score [QMG], and MG composite scale [MGC]) between groups and calculated cutoff values to separate the two groups. Using these cutoffs, patients subjectively assigned as MM-or-better were classified into strict MM-or-better (below a cutoff) or optimistic MM-or-better (above a cutoff) groups, and clinical characteristics were then compared. Cutoff values for strict MM-or-better were MG-ADL ≤2, QMG ≤7, and MGC ≤4 (sensitivity 82.0%, 88.7%, and 87.4%; specificity 85.0%, 70.0%, and 77.9%; and accuracy 91.2%, 88.7%, and 90.7%, respectively). Mean values of the revised 15-item MG quality of life scale were significantly lower in the strict MM-or-better group than in the optimistic MM-or-better group. Quantitative criteria for MM-or-better appear likely to be useful in the context of rigorous clinical trials and also as reference information in clinical settings.

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Publication Details

Journal
Frontiers in Immunology
Published
2024-12-23
DOI
https://doi.org/10.3389/fimmu.2024.1502721
Citations
8
Primary Topic
Myasthenia Gravis and Thymoma
Type
article
Field-Weighted Citation Impact
2.95

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article

Cutoffs on severity metrics for minimal manifestations or better status in patients with generalized myasthenia gravis

Akiyuki Uzawa, Itaru Amino, Kimiaki Utsugisawa, Naoki Kawaguchi et al.
8 citations
Frontiers in Immunology
Myasthenia Gravis and Thymoma
2.95
article

Cutoffs on severity metrics for minimal manifestations or better status in patients with generalized myasthenia gravis

Akiyuki Uzawa, Itaru Amino, Kimiaki Utsugisawa, Naoki Kawaguchi, Masayuki Masuda, Hiroyuki Akamine, Genya Watanabe, Tomoya Kubota, Yosuke Onishi, Manato Yasuda, Naoya Minami, Shingo Konno, Takashi Kimura, Yuriko Nagane, Takamichi Sugimoto, Masashi Aoki, Hiroyuki Murai, Makoto Samukawa, Masanori Takahashi, Yasushi Suzuki, Yoshiki Takai, Shigeaki Suzuki
article en
8 citations

Abstract

International consensus guidance and Japanese clinical guidelines for myasthenia gravis (MG) recommend achieving minimal manifestations or better status (MM-or-better) as the severity component of the treatment goal. However, the subjective nature of determining MM can result in ambiguity regarding this category in clinical practice and clinical trials. This study analyzed severity metrics in a large number of MG patients to propose criteria for MM-or-better. We utilized data obtained from 3800 MG patients who participated in nationwide cross-sectional surveys in Japan. Among these, 2784 patients with generalized MG were divided into two groups based on MG Foundation of America postintervention status: MM-or-better status (n = 1432); and improved-or-worse (I-or-worse) status (n = 1352). We compared severity metrics (MG-activities of daily living scale [MG-ADL], quantitative MG score [QMG], and MG composite scale [MGC]) between groups and calculated cutoff values to separate the two groups. Using these cutoffs, patients subjectively assigned as MM-or-better were classified into strict MM-or-better (below a cutoff) or optimistic MM-or-better (above a cutoff) groups, and clinical characteristics were then compared. Cutoff values for strict MM-or-better were MG-ADL ≤2, QMG ≤7, and MGC ≤4 (sensitivity 82.0%, 88.7%, and 87.4%; specificity 85.0%, 70.0%, and 77.9%; and accuracy 91.2%, 88.7%, and 90.7%, respectively). Mean values of the revised 15-item MG quality of life scale were significantly lower in the strict MM-or-better group than in the optimistic MM-or-better group. Quantitative criteria for MM-or-better appear likely to be useful in the context of rigorous clinical trials and also as reference information in clinical settings.

Frontiers in ImmunologyVol. 15
Hiroshima University (JP), Toho University (JP), Tokyo Medical University (JP), Chiba University (JP), Tohoku University (JP), Keio University (JP), National Hospital Organization Hokkaido Medical Center (JP), Sendai Medical Center (JP), National Hospital Organization Hanamaki Hospital (JP), National Hospital Organization (JP), International University of Health and Welfare (JP), Hyogo University (JP), Kindai University (JP), The University of Osaka (JP)
Alexion Pharmaceuticals, Japan Blood Products Organization, Argenx, Astellas Pharma, Mitsubishi Tanabe Pharma Corporation, Chugai Pharmaceutical, UCB Pharma
Openalex Percentile: Top 8%
Myasthenia Gravis and Thymoma
2.95
DOIOpen Access PDFOpenAlex
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