ICI therapy does not increase mortality risk in patients with pre-existing autoimmune disease

A large propensity-matched cohort study on immune checkpoint inhibitor (ICI) therapy provides further evidence that the mortality risk in patients with pre-existing autoimmune disease (AID) is not significantly different from those with no AID.

“Clinical trials of ICIs continue to exclude patients with pre-existing AID,” said Dr Greg Challener (Massachusetts General Hospital, MA, USA) [1]. This is due to concerns regarding exacerbation of underlying AID, possible interference between immunosuppression for AID and ICIs, and a theoretically increased risk of serious adverse events. Yet, several recent studies suggest equivalent survival rates in patients with and without AID [2–4].

To assess mortality risk in a national cohort of patients with pre-existing AID being treated with ICI therapy, Dr Challener and colleagues conducted a propensity-matched cohort study. They used a large, multicentre 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 AID in their history, totalling 25,153 ICI participants with known AID and 78,547 participants without known AID. After 1:1 propensity score matching, there were 2 cohorts of 23,714 participants.

After a median follow-up of 250 days, there was no significant mortality difference between the AID and non-AID groups. The mortality risk in the unmatched cohorts was 40.0% in the AID group and 38.1% in the non-AID 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 treating patients with pre-existing AID with immunotherapy is safe,” Dr Challener concluded. “Therefore, these patients should not be excluded from receiving this often life-saving therapy.” Furthermore, the adverse event risk assessment should be shared between oncologists and rheumatologists.

1. Challener GJ, et al. Mortality in patients with pre-existing autoimmune disease on immune checkpoint inhibitor therapy. Abstract 2532, ACR Convergence 2024, 14–19 November, Washington DC, USA.
2. Tang K, et al. J Natl Cancer Inst. 2022;114(8):1200-2.
3. McCarter KR, et al. Lancet Rheumatol. 2023;5(5):e274-83.
4. Ihara Y, et al. Biol Pharm Bull. 2024;47(2):454-61.

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Posted on 13 January 202513 January 2025