James Del Rosso, DO, gives an overview of deuruxilitinib for alopecia areata, including clinical trial results, the boxed warning, recommended laboratory testing, limitations, and more. 

Sun Pharmaceutical Industries Limited has announced the US FDA approval of LEQSELVI (deuruxolitinib) 8 mg tablets for treating adults with severe alopecia areata. LEQSELVI is an oral selective inhibitor of Janus kinases (JAK) JAK1 and JAK2. By interrupting pathways that contribute to hair loss, LEQSELVI provides a new avenue for treating severe alopecia areata. 

Clinical trial insights 

The approval of LEQSELVI is based on data from 2 multicenter, randomized, double-blind, placebo-controlled phase 3 clinical trials, THRIVE-AA1 and THRIVE-AA2, involving 1220 patients. The THRIVE-AA1 and THRIVE-AA2 trials were pivotal in evaluating LEQSELVI's effectiveness. These trials involved patients aged 18 to 65 with severe alopecia areata across the US, Canada, and Europe. Patients were randomized to receive either 8 mg or 12 mg twice daily of deuruxolitinib or a placebo for 24 weeks. The primary endpoint was the percentage of patients achieving a SALT score of 20 or less, indicating significant scalp hair regrowth. These patients had at least 50% scalp hair loss as measured by the Severity of Alopecia Tool (SALT). At baseline, the average patient had 13% scalp hair coverage; after 24 weeks, over 30% of patients taking LEQSELVI achieved 80% or more scalp hair coverage, with up to 25% of patients experiencing nearly full scalp hair regrowth. 

Safety profile 

While LEQSELVI has shown promising results, it may cause serious side effects, including infections, malignancies, thrombosis, gastrointestinal perforations, and certain laboratory abnormalities. Patients who are CYP2CP poor metabolizers or taking moderate or strong CYP2C9 inhibitors should not use LEQSELVI. The most common adverse events included headaches, acne, and nasopharyngitis.