Abstract
Patients with preexisting autoimmune disease (PAD) are often excluded from clinical trials assessing immune checkpoint inhibitors (ICIs). Therefore, the safety of ICI therapy in patients with PAD remains unclear. Herein, we evaluated the incidence of immune-related adverse events (irAEs) in patients with PAD when compared with non-PAD patients. We searched MEDLINE/PubMed, Web of Science, and Google Scholar for eligible studies from inception to January 2021. Observational studies reporting the incidence of irAEs in patients with and without PAD were included. We then performed a meta-analysis of eligible studies using forest plots. The primary endpoint of this study was the incidence rate of irAEs between patients with and without PAD. We identified three prospective and three retrospective studies involving 206 patients with PAD and 3078 patients without PAD. In the meta-analysis, 128 patients with PAD (62.1%) experienced irAEs, which occurred in 51.9% of non-PAD patients, resulting in an odds ratio (OR) of 2.14 (95% confidence interval [CI] 1.58-2.89). In the subgroup analysis, the incidence of irAEs was significantly higher in patients with PAD (OR = 2.19, 95% CI [1.55-3.08]). Furthermore, no significant heterogeneity or publication bias was detected, indicating that our meta-analysis could be generalized to clinical settings. This meta-analysis demonstrated that PAD was a risk factor for irAE incidence. These results suggest that monitoring the occurrence of irAEs in patients with PAD is required to manage irAEs appropriately.
Highlights
Immune checkpoint inhibitors (ICIs) have remarkable anticancer activity for treating several types of cancer [1]
In the meta-analysis, 128 patients with preexisting autoimmune disease (PAD) (62.1%) experienced immune-related adverse events (irAEs), which occurred in 51.9% of non-PAD patients, resulting in an odds ratio (OR) of 2.14 (95% confidence interval [CI] 1.58–2.89)
The incidence of irAEs was significantly higher in patients with PAD (OR = 2.19, 95% CI [1.55–3.08])
Summary
Immune checkpoint inhibitors (ICIs) have remarkable anticancer activity for treating several types of cancer [1]. ICIs block the immune system-mediated response toward tumors by interacting between cytotoxic T-lymphocyteassociated-4 (CTLA-4) and CD80/CD86, as well as between programmed cell death protein 1 (PD-1) and programmed cell death protein ligand 1 (PD-L1) [1]. Despite the significant efficacy of ICIs, adverse events associated with ICIs, called immune-related adverse events (irAEs), have been reported [2]. IrAEs are associated with the mechanism of ICI action and can involve multiple organs, including the skin, endocrine system, and gastrointestinal tract [3]. IrAEs are mild, and ICI therapy can be continued in most cases. Adequate management of irAEs is required to maximize the benefits of ICI therapy [3]
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