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Allenbach, Yves; Anquetil, Céline; Manouchehri, Ali; Benveniste, Olivier; Lambotte, Olivier; Lebrun-Vignes, Bénédicte; Spano, Jean-Philippe; Ederhy, Stéphane; Klatzmann, David; Rosenzwajg, Michelle; Fautrel, Bruno; Cadranel, Jacques; Johnson, Douglas B.; Moslehi, Javid J.; Salem, Joe-Elie
Autoimmunity reviews, August 2020, 2020-Aug, 2020-08-00, 2020-08, Volume: 19, Issue: 8Journal Article
In addition to restoring anti-tumor immune responses, immune checkpoint inhibitors (ICI) may also induce immune-related adverse events (irAE) that can affect any organ. We aim to determine the spectrum, timing, clinical features, and fatalities of rheumatic and musculoskeletal immune-related adverse events (RMS-irAE) associated with ICI. We performed an observational, retrospective, pharmacovigilance study using the World Health Organization international pharmacovigilance database, VigiBase, from inception to January 2019. RMS-irAE reporting rate on ICI versus full database was performed using disproportionality analysis with computation of reporting-odds-ratios (ROR) and a Bayesian disproportional estimate (information component, IC). IC025 (lower end of the IC 95% credibility interval) >0 is deemed significant. We identified 1288 RMS-irAE significantly associated with ICI: polymyalgia rheumatica (n = 76, ROR = 14.6 11.6–18.4, IC025 = 3.34), sarcoidosis (n = 94; ROR = 9.6 7.9–11.9; IC025 = 2.85), Sjogren's syndrome (n = 49; ROR = 6.9 5.2–9.2; IC025 = 2.24), myositis (n = 465; ROR = 4.9 4.5–5.4; IC025 = 2.12), arthritis (n = 606; ROR = 1.4 1.3–1.5; IC025 = 0.34) and scleroderma (n = 17; ROR = 2.0 1.2–3.2; IC025 = 0.17). Arthritis, myositis, and Sjogren's syndrome were over-reported in patients treated with ICI combination versus those treated with ICI monotherapy (ROR = 1.6–2.9, p < .05) and more frequently reported on anti-PD1/PDL1 monotherapy vs. anti-CTLA4 monotherapy (2.1–4.4, p < .05). Median time to onset occurred early for myositis (31 days 19.2–57.8) and was the most delayed for scleroderma (395 days 323.8–457.2, p < .0001). The fatality rate for RMS-irAE ranged from 24% for myositis (n = 106/441) (up to 56.7% with concurrent myocarditis) to 0–6.7% for other RMS-irAE (p < .0001). Clinicians should be aware of the spectrum of RMS-irAE. Myositis can be particularly life-threatening, particularly when associated with myocarditis. •We identified over 1000 individual case safety reports related to RMS-irAE induced by ICI.•RMS-irAE encompassed arthritis, myositis, sarcoidosis, polymyalgia rheumatica, Sjogren's syndrome, and scleroderma.•Myositis occurred early within weeks after initiation of ICI therapy and carried a high fatality rate, particularly when concurrent myocarditis was reported; whereas other RMS-irAE had a low mortality burden.
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