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 AIDS^2-4. 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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