The presence of autoimmune disease overall did not appear to increase mortality risk in a study of patients treated with immune checkpoint inhibitors from the anti-programmed cell death receptor-1 (anti-PD-1) or anti-programmed cell death-ligand 1 (anti-PD-L1) classes. However, risks may vary by type of autoimmune disease. Results of this retrospective study were published in the Journal of the National Cancer Institute.

Use of immune checkpoint inhibitors has been linked to development of certain immune-related adverse events of an autoinflammatory nature that are reminiscent of autoimmune diseases. However, as the study investigators explained in their report, the relationship between baseline autoimmune disease and mortality in patients receiving immune checkpoint inhibitors for cancer has been poorly understood. They undertook an analysis to explore this relationship.

Patients in the United States and Europe who were receiving either anti-PD-1 or anti-PD-L1 therapies for cancer treatment and who had preexisting diagnoses of autoimmune conditions were identified through the TriNetX Diamond NetworkTM. Anti-PD-1 therapies in this study included cemiplimab, nivolumab, and pembrolizumab. Anti-PD-L1 therapies included atezolizumab, avelumab, and durvalumab.

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For analyses, patients with autoimmune diagnoses (AD group) were matched with a control group of patients also identified through this network. Those in the control group were treated with immune checkpoint inhibitors, had no preexisting autoimmune diagnoses, and were propensity score matched to patients in the AD group based on age, sex, race, and cancer. There were 17,497 participants in each group for analyses.

Patients who had an autoimmune disease history, overall, showed a mortality risk that was similar to that of the control group (hazard ratio [HR], 1.03; 95% CI, 1.00-1.07; P =.05). The duration of immune checkpoint inhibitor therapy also was similar between groups, which suggests that treatment discontinuation was not significantly more common for patients with autoimmune disease histories.

Additionally, lower mortality risks were observed with certain autoimmune disease histories. These included Hashimoto’s disease (HR, 0.75; 95% CI, 0.62-0.90; P =.002), vitiligo (HR, 0.52; 95% CI, 0.34-0.81; P =.003), and others that showed lower mortality risks than were seen in the absence of an autoimmune disease history. Patients with type 1 diabetes, however, appeared to show a slightly higher mortality risk than patients without an autoimmune disease history (HR, 1.11; 95% CI, 1.03-1.19; P =.002).

“Hashimoto’s disease, vitiligo, lichen planus, celiac disease, and alopecia areata were seen here to be protective against mortality and are also diseases not commonly treated with systemic corticosteroids,” the study investigators reported.

They concluded that the presence of an autoimmune condition may not necessarily exclude a patient from receiving immune checkpoint inhibitor therapy. However, further research is needed to evaluate certain aspects of the relationship between autoimmune disease and immunotherapy outcomes.


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. Published online February 21, 2022. doi:10.1093/jnci/djac046