Safety and efficacy of immune checkpoint inhibitors in patients with melanoma and pre-existing autoimmune conditions: a systematic review and meta-analysis

Background: Melanoma patients with pre-existing autoimmune diseases (AIDs) have been excluded from clinical trials of immune checkpoint inhibitors (ICIs), due to a risk of flare and immune-related adverse effects (irAEs). Materials and methods: irAEs, AID flare, treatment discontinuation owing to adverse effect(s), treatment-related mortality and objective response rate (ORR). Treatment discontinuation, treatment-related mortality and ORR were not different among patients with AIDs. Conclusions: Melanoma patients with pre-existing AIDs are at significant risk of flare with ICI use. These patients had an increased risk of irAEs of any grade. Although there was a trend towards increased risk of severe irAEs, this was not statistically significant. irAEs did not result in treatment-related deaths, and there were no differences in treatment response. Risks should be discussed, coupled with close monitoring.