Expert opinion on drug safety · 2026
Myositis in cancer patients receiving immune checkpoint inhibitors: the ARON-MOUSEION-017 systematic review and meta-analysis.
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Vitale Elsa, Cazzato Gerardo, Maistrello Lorenza, Della Mura Mario, Maiorano Mauro Francesco Pio, Ciccimarra Francesco, Brunetti Oronzo, Calabrò Concetta, Maiorano Brigida Anna, Monteiro Fernando Sabino Marques, Erul Enes, Massari Francesco, Rizzo Alessandro, Santoni Matteo
Аннотация
BACKGROUND: Myositis may present as a treatment-related adverse event (TRAE) during immune checkpoint inhibitor (ICI) therapy. In the ARON-MOUSEION-017 meta-analysis, we aimed to assess the frequency of myositis among cancer patients treated with ICIs.
RESEARCH DESIGN AND METHODS: The present systematic review and meta-analysis was registered in PROSPERO with ID no. CRD420261278193. Embase, PubMed, Scopus and Web of Science databases were consulted, using Boolean terms and keywords 'Immunotherapy,' 'Myositis' and 'Neoplasms.'
RESULTS: For myositis of any grade, 13 studies were included, suggesting that heterogeneity across studies was high and statistically significant (p < 0.001; τ2 = 3.78; I2 = 95.3%, 95% CI [93.1%; 96.7%]), and the pooled proportion of patients affected by any-grade myositis treatment-related adverse events (TRAEs) was 4.2% (95% CI = [1.1%; 14.6%]).
CONCLUSIONS: ICI-myositis often appears in concomitance with other immune-mediated conditions, such as myocarditis and myasthenia gravis. These events are clinically relevant, since they are often associated with more severe disease courses and unfavorable outcomes, increasing morbidity and mortality.
RESEARCH DESIGN AND METHODS: The present systematic review and meta-analysis was registered in PROSPERO with ID no. CRD420261278193. Embase, PubMed, Scopus and Web of Science databases were consulted, using Boolean terms and keywords 'Immunotherapy,' 'Myositis' and 'Neoplasms.'
RESULTS: For myositis of any grade, 13 studies were included, suggesting that heterogeneity across studies was high and statistically significant (p < 0.001; τ2 = 3.78; I2 = 95.3%, 95% CI [93.1%; 96.7%]), and the pooled proportion of patients affected by any-grade myositis treatment-related adverse events (TRAEs) was 4.2% (95% CI = [1.1%; 14.6%]).
CONCLUSIONS: ICI-myositis often appears in concomitance with other immune-mediated conditions, such as myocarditis and myasthenia gravis. These events are clinically relevant, since they are often associated with more severe disease courses and unfavorable outcomes, increasing morbidity and mortality.