Deuruxolitinib achieved significant hair regrowth in 41.5% of patients with moderate-to-severe alopecia areata after 24 weeks of treatment, according to a Phase 3 clinical trial. 

The THRIVE-AA1 trial assessed the efficacy and safety of deuruxolitinib, an oral Janus kinase (JAK) 1/2 inhibitor, in adults with alopecia areata (AA) and at least 50% scalp hair loss. The randomized, double-blinded, placebo-controlled trial, published in the Journal of the American Academy of Dermatoloy, enrolled 706 participants aged 18 to 65 years, and were treated with deuruxolitinib 8 mg or 12 mg twice daily or a placebo for 24 weeks. The primary endpoint was achieving a Severity of Alopecia Tool (SALT) score of 20 or less, indicating 20% or less scalp hair loss.

At week 24, 41.5% of patients receiving 12 mg of deuruxolitinib and 29.6% of those receiving 8 mg achieved the primary endpoint, compared with 0.8% in the placebo group. Hair satisfaction, measured by patient-reported outcomes, aligned with these results, with 53% and 42.1% of patients in the 12 mg and 8 mg groups, respectively, reporting satisfaction compared with 4.7% in the placebo group. Significant improvements in SALT scores were observed as early as week 8 in both treatment groups.

Treatment-emergent adverse events (TEAEs) were reported in 65.1% and 63.7% of patients in the 8 mg and 12 mg groups, respectively, compared with 55.7% in the placebo group. Most TEAEs were mild or moderate, and serious TEAEs were uncommon. The safety profile of deuruxolitinib observed during the 24-week study was consistent with other JAK inhibitors. While no thromboembolic events were reported during the 24-week blinded phase of the study, longer-term monitoring during open-label extension studies identified thromboembolic events associated with the higher dose.

Deuruxolitinib demonstrated measurable hair regrowth as early as week 8 and a safety profile consistent with other JAK inhibitors, suggesting its potential as a treatment for adults with moderate-to-severe alopecia areata. However, researchers emphasized the need for further studies to evaluate its long-term safety, sustained efficacy, and treatment durability, supporting continued investigation of JAK inhibitors for alopecia areata.

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