Risk of Autoimmune Skin Diseases Associated With Immune Checkpoint Inhibitors: A Pharmacovigilance Analysis Using the FAERS Database

This study analyzed 1,670 cases from the FAERS database to assess the risk of autoimmune skin diseases (ASDs) associated with immune checkpoint inhibitors (ICIs). Bullous pemphigoid (BP) showed the strongest association, especially with PD-1/PD-L1 inhibitors, while vitiligo, psoriasiform dermatitis, lichen planus, and dermatomyositis were also significant. Alopecia areata and other ASDs showed limited signals. The median time-to-onset was 143 days, with early onset linked to ipilimumab and atezolizumab. Most reports involved males (62.8%) and patients aged ≥ 65 (51.7%), primarily from the US and Japan. The study highlights the need for vigilant monitoring and individualized management of these irAEs, noting limitations like reporting biases and underrepresentation of newer ICIs.