Autoimmune disease no contraindication for PD-(L)1 inhibitor

The results of a retrospective cohort analysis suggest that a baseline autoimmune disorder does not significantly worsen the clinical outcome of cancer patients treated with immune checkpoint inhibitors (ICI). According to the researchers, these preliminary data show that autoimmune disorders do not have to be a contraindication for inclusion in clinical trials and for treatment with ICI.

While indications for immunotherapy have increased significantly over the past decade, these treatments have been associated with autoinflammatory immune-related side effects that can resemble autoimmune disorders. Little is known about the impact of these conditions at baseline on mortality in cancer patients treated with ICIs. The researchers therefore identified 17,497 patients with autoimmune disorders prior to treatment with anti-PD-1 or anti-PD-L1 therapy and 17,497 matched controls through the TriNetX Diamond network.

Using a Cox proportional hazards model, it became clear that patients with a history of autoimmune disease had no higher risk of death compared to controls without autoimmune disease (HR 1.03; 95% CI 1-1.07; p = 0.05). In addition, a history of Hashimoto’s disease (HR 0.75; 95% CI 0.62-0.90; p = 0.002) and vitiligo (HR 0.52; 95% CI 0.34-0.81 ; p = 0.003) significantly associated with lower mortality. This suggests that underlying autoimmune disorders may not be a contraindication to clinical trial participation and ICI treatment. However, according to the researchers, further studies are needed to assess interactions between molecular targets of ICI and the influence of an autoimmune disease on outcome and to investigate the impact of systemic immunosuppressants on mortality in this setting.

Also read: Place neoadjuvant immunotherapy in melanoma investigated in NADINA and DONIMI


Tang K, Tiu BC, Wan G, et al. Pre-Existing Autoimmune Disease and Mortality in Patients Treated With Anti-PD-1 and Anti-PD-L1 Therapy. J Natl Cancer Inst. 2022 Feb 21. Online ahead of print.

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