Adrenal insufficiency in patients on immune checkpoint inhibitors: An All of Us Data study.

Abstract

e14675 Background: Immune Checkpoint Inhibitors have revolutionized the management of cancers. Several cases are reported about their adverse effects, which include adrenal insufficiency, a life-threatening irreversible sequela in some patients. Little has been done to evaluate the burden of this adverse effect on cancer patients. This study aimed to measure the incidence rate of adrenal insufficiency in patients on immune checkpoint inhibitors in the United States using the All Of Us database. Methods: In this cross-sectional study, we included participants from the All of Us dataset version 6, which includes data collected between May 6, 2018, and January 1, 2022, who had available Electronic Health Records data (N = 258,188). We defined the cancer cohort as having at least one ICD-9/ICD-10 diagnostic code for cancer. We identified participants in the cancer cohort without or with at least one exposure to immune checkpoint inhibitors nivolumab, pembrolizumab, cemiplimab, ipilimumab, atezolizumab, avelumab, durvalumab, tremelimumab, relatlimab, tremelimumab, pidilizumab. Adrenal insufficiency was defined as having one or more ICD-9/ICD-10 codes for any adrenal insufficiency after treatment with immune checkpoint inhibitors. The calculation for the Relative Risk(RR) was with unconditional maximum likelihood estimation. Results: Among 36,377 individuals diagnosed with cancer, 418 patients had exposure to immune checkpoint inhibitors. 44(10.5%) of the 418 were diagnosed with adrenal insufficiency after exposure to immune checkpoint inhibitors. The relative risk of adrenal insufficiency after the commencement of an immune checkpoint inhibitor is five times that of patients not on immune checkpoint inhibitors. (RR 5.43, 95% CI 4.07-7.25, P < 0.05). Conclusions: Our result suggests a higher incidence of adrenal insufficiency in cancer patients on immune checkpoint inhibitors compared to cancer patients, not on immune checkpoint inhibitors. Future prospective studies will be needed to confirm this finding. Physicians, particularly oncologists and endocrinologists, should have a high index of suspicion for adrenal insufficiency in patients on immune checkpoint inhibitors.