Biologics for the treatment of alopecia areata: A comprehensive review of clinical trials

Summary: Abstract Body: Alopecia areata (AA) is an autoimmune condition affecting approximately 2% of the global population. Although corticosteroids and JAK inhibitors are effective for treating localized AA, more effective treatments with lower toxicity are needed for advanced disease. Recently, biologics have emerged as promising therapeutic alternatives. This review analyzed clinical trials indexed on PubMed to assess the efficacy of various biologics for the treatment of AA. Studies examining Dupilumab, Secukinumab, Tralokinumab, Abatacept, Alefacept, Efalizumab, and Aldesleukin were identified. Dupilumab, an interleukin (IL)-4 and IL-13 antagonist, demonstrated SALT30, SALT50, SALT75, and SALT90 responses in 32.5%, 22.5%, 15%, and 10% of patients (n=40), respectively. Abatacept, a CTLA-4 modulator, resulted in 91% hair regrowth in one patient, partial regrowth (3-25%) in eight patients, and no response in those with alopecia totalis or universalis. A phase II trial of tralokinumab, an IL-13 inhibitor, had a high dropout rate due to poor efficacy, with only 33.75% improvement observed across patients. Secukinumab, an IL-12 and IL-23 inhibitor, showed no response in 71% of the seven treated patients. Aldesleukin, a recombinant IL-2 analog, achieved a 50% SALT reduction in 14.3% of treated patients compared to 9.1% in the placebo group (n=21). Both alefacept and efalizumab were ineffective for AA treatment. Biologics offer a favorable safety profile and hold potential as therapeutic options for AA, although response rates remain inconsistent. Further research is needed to optimize these therapies, identify more effective targets, and determine predictors of clinical response. Simonetta I. Gaumond^{1, 2}, Isabella Kamholtz¹, Madisyn Opstal¹, Joaquin J. Jimenez^{1, 2} 1. Dr. Phillip Frost Department of Dermatology and Cutaneous Surgery, University of Miami Miller School of Medicine, Miami, FL, United States. 2. Department of Biochemistry and Molecular Biology, University of Miami Miller School of Medicine, Miami, FL, United States. Clinical Research: Interventional Research