2179P - Prospective monitoring of autoimmune events in cancer immunotherapy patients: A report on the first 658 patients in the PRAISE study

Background

In cancer immunotherapy, the epidemiology of irAE in real-life is poorly understood due to limited reporting and compartmentalization of the healthcare system. This study aims to determine the incidence, severity, and consequences of irAE of all grades in patients initiating cancer immunotherapy using a prospective and multicenter cohort.

Methods

The study will include 900 patients treated with ipilimumab and/or nivolumab in a French real-life, longitudinal, observational, and e-cohort study. Data collection is conducted through digital questionnaires, with physician validation and soon-to-be-matched analysis with the National Health System.

Results

658 patients (70.7% men, 29.3% women, mean age 66) were followed up for a median of 198 days. Of those, 75.8% were treated with Nivolumab alone, 1.2% with Ipilimumab alone, and 22.9% with a combination. Lung cancer, clear cell renal carcinoma, and melanoma were the most common histological types treated. At analysis, 115 immune related adverse events (irAE) were observed in 11.7% of patients (30.5 irAE/100 patient/years) at a median time of 155 (+/- 128) days after initiating immunotherapy. Approximately 30% of reported irAE were rheumatological, and the remaining cases included: colitis (15), hepatitis (8), pancreatitis (2), ileitis (1), myocarditis (2), nephritis (2), immuno-induced pneumopathy (3), macrophage activation syndrome (1), type 1 diabetes (2), hypophysitis (3), adrenal insufficiency (9), thyroid disorder (15), bullous pemphigoid (1), uveitis (1), and other autoimmune manifestations (23). 40 patients discontinued immunotherapy due to irAE, and treatment with corticosteroids was administered in 44 patients (57.1%). Methotrexate (n=1), infliximab (n=3), and abatacept (n=1) were also used to treat specific irAE. One patient died as a result of irAE (colitis).

Conclusions

The preliminary results of this prospective study, using an original patient-centered methodology, confirm the expected incidence of secondary autoimmune events related to immunotherapy. Further inclusions and matching with the SNDS database will allow for the completion of these initial analyses if necessary.

Clinical trial identification

Editorial acknowledgement

Legal entity responsible for the study

The authors.

Funding

BMS does not have access to the data and does not contribute to its analysis or interpretation.

Disclosure

All authors have declared no conflicts of interest.