A large propensity-matched cohort study on immune checkpoint inhibitor (ICI) therapy provides further evidence that the mortality risk in patients with pre-existing auto-immune disease (AIDS) is not significantly different from those with no AIDS.
“Clinical trials of ICIs continue to exclude patients with pre-existing AIDS,” said Dr. Greg Challener, from the Massachusetts General Hospital, who presented the results of the cohort study1. This is due to concerns regarding exacerbation of underlying AIDS, possible interference between immunosuppression for AIDS and ICIs, and a theoretically increased risk for serious AEs. Yet, several recent studies suggest equivalent survival rates in patients with and without AIDS2-4. To assess mortality risk in a national cohort of patients with pre-existing AIDS being treated with ICI therapy, Dr. Challener and colleagues conducted a propensity-matched cohort study. The researchers used a large, multicenter network of electronic health records in the USA. The study population consisted of adult patients with cancer treated with ICIs (i.e. anti-PD-1/PD-L1), with or without auto-immune disease in their history. The study included 25,153 ICI participants with known AIDS and 78,547 participants without known AIDS. After 1:1 propensity score matching, there were two cohorts of 23,714 participants. All participants were followed for a median of 250 days.
No significant mortality difference between the AIDS and non-AIDS group was found. The mortality risk in the unmatched cohorts was 40.0% in the AIDS group and 38.1% in the non-AIDS group (HR 1.07; 95% CI 1.05–1.10). In the matched cohorts, these rates were 39.8% and 40.2%, respectively (HR 0.97; 95% CI 0.94–1.00).
“These results suggest that it is safe to treat patients with pre-existing AIDS with immunotherapy,” Dr. Challener concluded. “So, these patients should not be excluded from receiving this often live-saving therapy.”
Medical writing support was provided by Michiel Tent
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