Survival outcomes with immune checkpoint inhibitors in patients with pre-existing autoimmune disease: A global federated database analysis.

Abstract

e24171 Background: Patients with pre-existing autoimmune diseases (pAI) have historically been excluded from pivotal immune checkpoint inhibitor (ICI) clinical trials due to concerns regarding exacerbated toxicities and potentially diminished antitumor efficacy. Consequently, real-world data on the long-term survival of this population remains limited. This study aimed to determine if pAI impacts overall survival (OS) in patients receiving ICIs for advanced malignancies. Methods: Using the TriNetX Global Collaborative Network (170 healthcare organizations), we identified adult patients with advanced solid tumors treated with ICIs. The pAI cohort included patients with a diagnosis of rheumatoid arthritis, systemic lupus erythematosus, ulcerative colitis, psoriasis, or Sjögren syndrome within one month prior to ICI initiation. From an initial pool of 198,224 controls and 8,629 pAI patients, a 1:1 propensity score match (PSM) was performed. Cohorts were balanced for age, sex, race, ethnicity, and comorbidities (diabetes, hypertension, atrial fibrillation). The primary endpoint was overall survival (OS) analyzed via Kaplan-Meier and Cox proportional hazards models. Results: PSM yielded two well-balanced cohorts of 7,132 patients each (N = 14,264). Baseline characteristics showed no significant differences after matching (p > 0.05). Median OS was 896 days in the pAI cohort compared to 882 days in the matched control cohort (Log-rank p = 0.168). The risk of mortality was equivalent between groups with a Hazard Ratio (HR) of 1.035 (95% CI, 0.985–1.088; p = 0.165). Five-year survival probabilities were 28.21% for the pAI group and 26.16% for the control group. Risk analysis further confirmed no significant difference in the total incidence of mortality (43.8% vs. 44.5%; p = 0.409). Conclusions: PSM yielded two well-balanced cohorts of 7,132 patients each (N = 14,264). Baseline characteristics showed no significant differences after matching (p > 0.05). Median OS was 896 days in the pAI cohort compared to 882 days in the matched control cohort (Log-rank p = 0.168). The risk of mortality was equivalent between groups with a Hazard Ratio (HR) of 1.035 (95% CI, 0.985–1.088; p = 0.165). Five-year survival probabilities were 28.21% for the pAI group and 26.16% for the control group. Risk analysis further confirmed no significant difference in the total incidence of mortality (43.8% vs. 44.5%; p = 0.409).