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

This study utilized the FAERS database to assess the risk of autoimmune skin diseases (ASDs) linked to immune checkpoint inhibitors (ICIs), analyzing 1,670 cases from 2011 to 2024. Bullous pemphigoid (BP) was most strongly associated with ICIs, particularly PD-1/PD-L1 inhibitors, while vitiligo, psoriasiform dermatitis, lichen planus, and dermatomyositis also showed notable links. Alopecia areata and systemic lupus erythematosus had limited signals. The median time-to-onset for these conditions was 143 days, with early onset linked to ipilimumab and atezolizumab. The study highlighted the need for vigilant monitoring and individualized management, noting limitations such as biases in reporting and underrepresentation of newer ICIs. Most reports involved males (62.8%) and patients aged 65 and older (51.7%), with significant contributions from the US and Japan.