Abstract
BackgroundThe ImmunoCancer International Registry (ICIR) is a Big Data-Sharing multidisciplinary network composed by 39 specialists in Rheumatology, Internal Medicine, Immunology and Oncology from 18 countries focused on immune-related adverse events (irAEs) related to cancer immunotherapies (CIs).ObjectivesTo analyse the worldwide scenario of irAEs associated with the use of CIs in this Century.MethodsThe first objective of the ICIR has been the development of a systematic literature review crossing CIs terms with immune diseases defined according to MedDRAVR 15.0.ResultsThe cumulated number of cases per year of irAEs has increased exponentially, with 12,648 patients who developed 13,051 irAEs reported until Dec 31, 2018:Combined CIs were used in 1962 (16%) patients, checkpoint inhibitors in 7099 (66%, overwhelmingly CTLA4 and PD1 inhibitors) and Tyrosine Kinase inhibitors in 3327 (31%); ipilimumab, nivolumab and pembrolizumab were associated with nearly 60% of reported cases. Organ-specific classification of irAEs is summarized in the figure:The Top10 irAEs included enterocolitis (18%), pneumonitis (12%), thyroiditis (11%), myocarditis (6%), myositis (5%), hypophysitis (5%), hepatitis (5%), neuropathy (4%), adrenal (3%) and joint involvement (3%). Most irAEs are organ-specific symptoms not fulfilled criteria of systemic/rheumatic diseases.ConclusionMore than 13,000 cases of irAEs triggered by CIs have been reported, with the organ-specific autoimmune damage of the endocrine, digestive and pulmonary systems accounting for 70% of the total reported irAEs.