Background/Purpose: Immune checkpoint inhibitors (ICI) are increasingly used in the treatment of cancer. To date, no clinical trials exist evaluating the use of ICI in patients with autoimmune disease. Therefore, we have systematically reviewed observational studies reporting the outcomes of cancer patients with pre-existing autoimmune disease to determine the frequency of flares, de novo immune-related adverse events (irAEs), and deaths.

Methods: We searched in 5 electronic databases through August 2018. Study selection, data collection and quality assessment were performed by one investigator and cross-checked by another. A meta-analysis was performed to pool occurrence of flares, de novo irAEs, and deaths.

Results: Eleven observational studies were included (868 patients with cancer and preexisting autoimmune disease). Four studies were comparative. All studies included patients with advanced cancer stages. Seven studies reported therapy with PD-1/PD-L1, three CTLA-4, and one both. The mean age of the participants ranged from 54 to 72 years of age. The risk of bias score for cohort studies ranged from four to seven points (out of a maximum of 9). Pooled occurrence of any irAEs (flares or de novo) was 55% (95% confidence interval (CI) 44%, 66%); for flares it was 29% (95% CI 11%, 49%), and for de novo irAEs 30% (95% CI 24%, 35%). Flares were more commonly reported in patients with rheumatoid arthritis (33%) and psoriasis (20%). Pooled occurrence of deaths was 31% (95% CI 11%, 56%), one due to de novo colitis, however none were considered to be related to the pre-existing autoimmune disease. The pooled proportion of permanent discontinuation of the ICI was 12% (95% CI 4%, 24%), and for patients with partial cancer response 25% (95% CI 15%, 36%).

Conclusion: Over 40% of the patients with pre-existing autoimmune disease received ICI blockade with no subsequent flares or de novo irAE. These results suggest that ICI can be used in these patients, but careful monitoring is required as close to one third of the patients will experience a flare of their autoimmune disease.

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ACR Meeting Abstracts - https://acrabstracts.org/abstract/a-systematic-review-and-meta-analysis-of-observational-studies-reporting-on-the-use-of-checkpoint-inhibitors-in-patients-with-cancer-and-pre-existing-autoimmune-disease/