Patients with autoimmune disease ‘should not be excluded’ from checkpoint inhibitors
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WASHINGTON — Preexisting autoimmune diseases do not increase mortality risk in patients treated with immune checkpoint inhibitors for cancer, according to data presented at ACR Convergence 2024.
“The objective of this study was to assess mortality risk in a national cohort of patients with preexisting autoimmune diseases being treated with immune checkpoint inhibitor therapy,” Gregory Challener, MD, of Massachusetts General Hospital, told attendees. “Clinical trials for immune checkpoint inhibitors continue to exclude patients with preexisting autoimmune diseases.”
The researchers examined data from the TriNetX Diamond network of electronic health records, which included information for more than 200 million patients. The analysis included 25,153 patients with a known autoimmune disease who were being treated with anti-programmed death-1/programmed death ligand-1 (PD-1/PD-L1) immunotherapy for common malignancies in the skin, lung/bronchus, digestive organs or urinary tract. Findings for this group were compared with data for 78,547 patients without known autoimmune diseases.
Before propensity score matching, the patient population with autoimmune diseases demonstrated higher rates of comorbidities when compared with the non-autoimmune disease cohort. For example, rates of type 2 diabetes mellitus were 42% for the autoimmune group and 24.8% for the non-autoimmune group. A similar trend was observed for chronic kidney disease (25.6% vs. 15.5%) and ischemic heart disease (39.2% vs. 28.4%), according to the researchers.
“However, after propensity score matching, they were balanced,” Challener said, noting that both propensity-matched groups included 23,714 patients.
Meanwhile, results of the analysis before propensity score matching showed mortality rates of 40% for the autoimmune disease group, and 38.1% for the non-autoimmune disease group (HR = 1.07; 95% CI, 1.05-1.10).
However, for the matched analysis, mortality rates were 39.8% for the autoimmune disease group and 40.2% for those without autoimmune diseases (95% CI, 0.94-1), according to the researchers.
“The difference was not significant,” Challener said. “The lines essentially overlap for the full duration.”
The findings could have a significant impact on the makeup of clinical trial populations for immune checkpoint inhibitors moving forward, according to Challener.
“These results suggest that it is safe to treat patients with preexisting autoimmune diseases with immunotherapy,” he said. “Patients with autoimmune disease should not be excluded from this treatment.”
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Challener G. Abstract #2532. Presented at: ACR Convergence 2024; Nov. 14-19, 2024; Washington, D.C.
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