THU0628 IMMUNE-RELATED ADVERSE EVENTS INDUCED BY CANCER IMMUNOTHERAPIES. BIG DATA ANALYSIS OF 13,051 CASES (IMMUNOCANCER INTERNATIONAL REGISTRY)

Background The 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). Objectives To analyse the worldwide scenario of irAEs associated with the use of CIs in this Century. Methods The 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. Results The 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. Conclusion More 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. Disclosure of Interests Manuel Ramos-Casals: None declared, Oliver Lambotte: None declared, Marie Kostine: None declared, Leonard Calabrese Consultant for: Bristol-Myers-Squibb, Genentech and Astra-Zeneca., Maria Suarez-Almazor : None declared, Clifton Bingham Grant/research support from: BMS, Consultant for: AbbVie, BMS, Eli Lilly, Genentech/Roche, Janssen, Pfizer, Sanofi/Regeneron, Timothy R. Radstake: None declared, Chiara Baldini: None declared, Thierry Schaeverbeke: None declared, Jacques-Eric Gottenberg Grant/research support from: Bristol-Myers Squibb, Grant/research support from: Bristol-Myers Squibb, Consultant for: Bristol-Myers Squibb, Lilly, Pfizer, Sanofi-Genzyme, UCB Pharma, Consultant for: Bristol-Myers Squibb, Eli Lilly, UCB, Sanofi-Genzyme, Pfizer, Hendrik Schulze-Koops Grant/research support from: Novartis, Pfizer, Roche, Consultant for: Abbvie, Actelion, Amgen, AstraZeneca, Biogen International, BMS, Celgene, Chugai, GSK, Hospira, Janssen-Cilag, Leo Pharmaceuticals, Lilly, MSD, Medac, Merck, Novartis, Pfizer, Hexal Sandoz, Sanofi, Roche, UCB, Paid instructor for: Abbvie, Actelion, Amgen, AstraZeneca, Biogen International, BMS, Celgene, Chugai, GSK, Hospira, Janssen-Cilag, Leo Pharmaceuticals, Lilly, MSD, Medac, Merck, Novartis, Pfizer, Hexal Sandoz, Sanofi, Roche, UCB, Speakers bureau: Abbvie, Actelion, Amgen, AstraZeneca, Biogen International, BMS, Celgene, Chugai, GSK, Hospira, Janssen-Cilag, Leo Pharmaceuticals, Lilly, MSD, Medac, Merck, Novartis, Pfizer, Hexal Sandoz, Sanofi, Roche, UCB, Jan Leipe Grant/research support from: Novartis, Pfizer; Scientific Support: Novartis, Pfizer, Consultant for: AbbVie, AstraZeneca, Bristol-Myers Squibb, Celgene, Hospira, Janssen-Cilag, LEO Pharma, Lilly, Novartis, Roche, Sanofi, Speakers bureau: AbbVie, Bristol-Myers Squibb, Celgene, Janssen-Cilag, Lilly, Novartis, MSD, Pfizer, Roche, Sanofi, UCB, cassandra calabrese Speakers bureau: Regeneron/Sanofi, Pilar Brito-Zeron: None declared, Alejandra Flores-Chavez: None declared, Belchin Kostov: None declared, Soledad Retamozo: None declared, Gustavo Citera: None declared, Eva Aguilar: None declared, Michael Richter: None declared, Merav Lidar: None declared, Benjamin Fisher Consultant for: Novartis, Roche, MedImmune, Bristol-Myers Squibb, Jean-Marie Michot: None declared, David Liew: None declared, Russell Buchanan: None declared, Marte Schrumpf-Heiberg: None declared, Philippe Guilpain: None declared, Debashish Danda: None declared, Peter Olsson: None declared, Yasunori Suzuki: None declared, Saadettin Kilickap: None declared, Gabriela Hernandez-Molina: None declared, Virginia Fernandes Moca Trevisani: None declared, Sonja Praprotnik: None declared, Ildiko Fanny Horvath: None declared, Naoto Azuma: None declared, Berkan Armagan: None declared, Munther Khamashta: None declared, Xavier Mariette Grant/research support from: Servier, Consultant for: AstraZeneca, Bristol-Myers Squibb, GlaxoSmithKline, Janssen, Pfizer, UCB Pharma