THU0665 Pharmacovigilance surveillance of autoimmune diseases induced by biological agents: a review of 16123 cases (AEBIOGEAS-SEMI REGISTRY)

Objectives The increasing use of biological agents has been linked with the paradoxical development of autoimmune processes. The scenario has dramatically change in recent years due to the increased number of biologics used in daily practice and the emerging use of biologics in patients with solid cancers. Methods In 2006, the Study Group on Autoimmune Diseases (GEAS) of the Spanish Society of Internal Medicine created the BIOGEAS project, a multicenter study devoted to collecting data on the use and safety of biological agents in adult patients. The aeBIOGEAS Registry (autoimmune events) was designed to collect data on autoimmune diseases secondary to the use of biologic agents, with the aim of formulating a standardised, consensual protocol for these patients, through a systematic and yearly MEDLINE search. We present the updated results of the aeBIOGEAS Registry (cases collected until Dec 31, 2017). Results The aeBIOGEAS Registry currently includes 16 123 cases of more than 50 different systemic and organ-specific triggered autoimmune diseases related to the administration of 46 different biological molecules in patients with inflammatory diseases (9907 cases, overwhelmingly rheumatic diseases in 8639) and cancer (6216 cases, overwhelmingly solid neoplasia in 5955). The main biological agents identified consisted of anti-TNF agents in 9514 cases (mainly adalimumab in 4147, infliximab in 3028 and etanercept in 1648), checkpoint inhibitors in 5264 (overwhelmingly the CTL4 inhibitor ipilimumab in 4980 cases), thyrosine kinase inhibitors in 952 (mainly imatinib in 377 cases) and B-cell targeted therapies in 298 cases. Organ-specific classification of triggered autoimmune diseases included cutaneous (n=7140), digestive (n=2323), endocrine (n=1701), pulmonary (n=1683), systemic/rheumatic (n=1230), neurological (n=1172), ocular (n=349), cardiac (n=322), haematological (n=106) and renal (n=96) diseases. The most frequently reported induced individual autoimmune diseases were psoriasis (n=6401), enterocolitis (n=1947), interstitial lung diseases (n=1680), thyroiditis (n=1076), hypophysitis (n=492), demyelinating CNS diseases (n=452), peripheral neuropathies (n=431), lupus (n=371), vasculitis (n=339), uveitis (n=298), vitiligo (n=256) and sarcoidosis (n=185). Conclusions The number and diversity of induced autoimmune disorders is increasing exponentially in parallel with the increased use of biological therapies in neoplasic diseases, which are currently representing 40% of reported cases. Management of these biologic-induced autoimmune diseases will be an increasing multidisciplinary clinical challenge in the daily practice in the next years. Disclosure of Interest None declared