Efficacy and safety of emerging immunomodulatory agents versus standard therapies in refractory cutaneous lupus: A systematic review.

Refractory cutaneous lupus (RCL) remains challenging to treat, with limited response to standard therapies. Emerging immunomodulatory agents, including thalidomide, lenalidomide, anifrolumab, belimumab, and intravenous immunoglobulin, may offer improved outcomes. To evaluate the efficacy and safety of emerging immunomodulatory agents in adults with RCL. A systematic review was conducted following PRISMA guidelines. Randomized controlled trials evaluating the efficacy and safety of the specified agents in adults with RCL were included. Databases searched included MEDLINE, Embase, and LILACS. Primary outcomes were CLASI, BICLA, and SRI-4 response rates. Secondary outcomes included adverse events and quality of life. Anifrolumab achieved CLASI-50 in up to 63.0% of patients versus 30.8% with placebo and BICLA response in up to 53.5% versus 25.7%. Belimumab improved SRI-4 response to 43.2% versus 33.5% with placebo. RSLV-132 and tofacitinib demonstrated partial efficacy. Herpes zoster was more frequent with anifrolumab. Anifrolumab and belimumab provide superior efficacy with acceptable safety in RCL, supporting their inclusion in personalized treatment algorithms.