LAUSR

e14256 Background: Understanding immune-related adverse events (irAEs) for different age groups is crucial in the era of immunotherapy. The aim of our study is to assess the irAE profiles in different age groups (≤65 and > 65 years) for drugs that target PD1/PDL1, CTLA4, and their combination. Methods: Data were obtained from the FDA Adverse Event Reporting System database from Jan 2014 to Sep 2018. We extracted the data based on reported irAEs and reviewed 30 different irAEs including, but not limited to colitis, pneumonitis, interstitial lung disease (ILD), myocarditis and pneumonitis. Cases with missing data, another drug reported with the PD1/PDL1 or CTLA4 combinations, and duplicate cases were excluded. We calculated the reporting odds ratio (ROR) for irAE associated with the use of PD1/PDL1, CTLA4 and combination, respectively. Results: A total of 6197 reported irAEs cases were included: 3140 cases from patients ≤65 years and 3057 from > 65 years old. Colitis was the most common irAEs in both groups. The RORs (95% CI) in patients using CTLA4 alone, PD1/PDL1 alone or the combination were 4.17 (3.47-5.02), 0.6 (0.5-0.72), 1.98 (1.64-2.39) for colitis; 0.21 (0.09-0.52), 2.94 (1.97-4.38), 2.2 (1.46-3.3) for diabetic ketoacidosis; 0.29 (0.09-0.92), 16.5 (6.54-41.9), 0.18 (0.04-0.73) for rheumatoid arthritis in ≤65 age group. In > 65 age group, the RORs (95% CI) in patients using CTLA4 alone, PD1/PDL1 alone or the combination were 4.79 (3.49-6.58), 0.56 (0.4-0.78), 2.84 (2.06-4) for hypophysitis; 0.12 (0.06-0.24), 28.53 (18.5-44), 0.17 (0.1-0.29) for interstitial lung disease (ILD); 0.38 (0.19-0.78), 2.87 (2.01-4.1), 2.41 (1.64-3.54) for myocarditis. When we compared all the studied irAEs between age groups (≤65 and > 65) by ROR, the only statistically significant irAE was ILD. The RORs (95%CI) for ILD associated with PD1/PDL1 in age≤65 and > 65 were 11.3 (7.65-16.8) & 28.53 (18.49-44.02). Conclusions: There was no significant difference between irAEs in different age groups except with ILD, which is more commonly seen in the > 65 age group. The ROR combination irAE profiles provide hypothesis generating information regarding association between irAEs and the use of various immune therapies.