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As shown by Kostine et al,1 and recently underlined by Ceccarelli et al,2 rheumatic inflammatory disorders induced by anticancer therapy are becoming a major concern for rheumatologists at the era of immune checkpoint inhibitors (ICIs). Beyond inflammatory arthritis, which may concern 10%–20% of patients, myositis represents a rare (<1%) but potentially life-threatening event. We thus aimed at investigating the risk of ICI-related myositis in real-life setting using VigiBase, the WHO’s pharmacovigilance database.
First, we analysed the myositis case associated with ICIs (Anti-Programmed Death (PD)-1, anti-Programmed Death Ligand (PDL)-1, and anti-Cytotoxic-T-Lymphocyte-Associated Protein (CTLA)-4 agents) reported to VigiBase. From 14 786 263 adverse drug reactions (ADRs) recorded between 1 January 2008 and 12 February 2019, we identified 54 085 ICI-related ADRs including 345 myositis (0.6%) (table 1). Among myositis cases, 85.2% occurred with anti-PD-1 or anti-CTLA-4 monotherapies, while 14.8% with combination therapy. Lung (34.8%) and skin cancers (34.2%) were the most frequent indications for ICI therapy. ICI-related myositis was more frequent in male patients, and over 65 years. The median time to onset was 4–5 weeks ranging from 1 day to 20 months, consistently with other reports.3 Almost all ICI-related myositis (95.3%) were considered serious (ie, requiring at least a hospitalisation), with a fatality rate of 22.3%. Myocarditis and myasthenia were associated with ICI-related myositis in 11.3% and 11.9% of cases and resulted in death in 51.3% and 26.8%, respectively.
Second, using case/non-case analyses,4 we found …
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