Safety and Efficacy of Immune Checkpoint Inhibitors in Advanced Cancer patients with Autoimmune Disease: a Meta-Analysis

Abstract Background Cancer patients with autoimmune disease (AID) usually have been excluded from the clinical trials of immune checkpoint inhibitors (ICIs). The safety and effectiveness of ICIs for these patients remain uncertainty. Methods A systematic search was conducted in available electronic database. We collected the incidence of immune-related adverse events (irAEs), progression-free survival (PFS) and overall survival (OS) from included studies. Results 11 studies including 5489 participants were incorporated in our meta-analysis. The pooled risk ratio (RR) for any grade and grade ≥ 3 irAEs were 1.79 (95% CI: 1.31–2.45) and 1.58 (95% CI: 1.06–2.36), respectively. When irAEs were from the same system as AID, we called the irAEs as AID-homogeneous irAEs, otherwise as AID-heterogeneous irAEs. Subgroup analysis found that the higher risk of AID-homogeneous irAEs contributed to the higher risk of overall irAEs of AID patients. The pooled hazard ratio (HR) for PFS and OS were 1.09 (95% CI: 0.96–1.25) and 1.10 (95% CI: 0.68–1.77), respectively. The results of subgroup analyses for PFS and OS matched the overall results well. Conclusion AID patients were significantly associated with a higher risk of irAEs in any grade and ≥ 3 grade under ICIs therapy. Specifically, AID-homogeneous irAEs but AID-heterogeneous irAEs were higher in AID patients than without AID patients. No statistically significant difference in PFS and OS were observed in patients with and without AID.