1. There was no significant difference in efficacy of ICIs in cancer patients with or without AID.

2. Immune-related toxic effects in AID patients was associated with an improved overall survival, but was the opposite for active AID patients.

Evidence Rating Level: 2 (Good)

Study Rundown: Immune checkpoint inhibitors (ICIs) can lead to immune-related adverse events. As such, patients with autoimmune disease are often excluded from clinical trials with ICIs due to concerns for increased toxicity. This study explored the efficacy and safety of ICIs in patients with cancer and autoimmune disease (AID), as well as the association of immune-related toxic effects (irTEs) with outcomes in a pancancer cohort. The most common AID diagnoses were psoriasis and rheumatoid arthritis. Equivalent rates of tumour response and overall survival were observed in patients with AID and without AID. However, patients with active AID (AID requiring systemic immunosuppression at ICI initiation) had poorer overall survival. In AID patients who experienced irTEs, there was an improved overall survival. Disease flares were mostly mild, whereby only a third of cases required systemic immunosuppression but nearly 60% experienced some of immune-related toxicity. Patients with active AID had more disease flares that those with latent disease. Limitations to this study include its retrospective design and the fact that this pancancer cohort may not be representative of all cancer types. The strength of this study is that it suggests there were no significant differences in response rates and survival in AID and non-AID patients, thereby suggesting that the AID cohort should be safe to include in clinical trials with ICIs. Overall, the efficacy and safety of ICIs are similar in cancer patients with and without AID.

Click to read the study in JAMA Oncology

Relevant Reading: Efficacy and toxicity of immune -checkpoint inhibitors in patients with preexisting autoimmune disorders

In-Depth [retrospective cohort]: This retrospective cohort study analyzed the records of 1822 patients with solid tumours who received ICIs or combination therapy (chemotherapy plus ICIs). Of these patients, 147 (8.1%) had AID. Most common AID diagnoses were psoriasis (38 patients) and rheumatoid arthritis (18 patients). Tumour response rates in the AID cohort was 28.6% and 25.7% in the non-AID cohort (P=0.43). No significant difference in overall survival between both cohorts was observed either (hazard ratio [HR], 0.95; 95% confidence interval [CI], 0.76 to 1.17; P=0.61). However, patients with active AID had poorer overall survival (HR, 2.81; 95% CI, 1.41 to 5.58; P=0.003). Overall survival was higher for AID patients with irTEs (HR, 0.55; 95% CI, 0.32 to 0.95; P=0.03). Mild disease flares occurred in most patients; 81% were of grade 1, 19% were of grade 2, and 33% were of grade 3. Only 33% of patients with disease flares needed systemic immunosuppression. Patients with active AID had more flares (60% vs. 22.1%; P<0.001). Overall, safety and efficacy of ICIs on AID cancer patients was similar to non-AID patients, with irTEs being associated with more higher immunotherapy efficacy.

Image: PD

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