Oral deuruxolitinib revealed significantly higher rates of hair re-growth than placebo in patients with moderate-to-severe alopecia areata, in the THRIVE-AA1 trial. As of week 8, differences in Severity of Alopecia Tool (SALT) score reduction were observed.
The JAK1/2 inhibitor deuruxolitinib was further assessed in phase 3, after having demonstrated favorable results as a treatment for alopecia areata in phase 2. Results from the THRIVE-AA1 trial were presented by Maryanne Makredes Senna, MD, at the 2023 American Academy of Dermatology annual meeting.1
In total, 706 adult patients with a SALT score of 50 or greater were included in the trial. At baseline, the mean duration of the current episode was 3.7 years, the mean SALT score was 85.9, and complete or near-complete hair loss (SALT ≥95) was present in 55.8% of participants. Patients were randomized 2:3:5 to receive placebo, deuruxolitinib 12 mg twice daily (BID), or deuruxolitinib 8 mg BID. Attaining a SALT score of 20 or less at week 24 was defined as the primary endpoint.
The primary endpoint was met by both dosing regimens: 29.6% on 8 mg BID and 41.5% on 12 mg BID (P<0.0001 vs placebo for both comparisons). As of week 8, the SALT-score differences between the active agent (low and high group) versus placebo were significant. The proportions of patients with a SALT score of 10 or less at week 24, a secondary endpoint, were 0%, 20.8%, and 34.5% for placebo, deuruxolitinib 8 mg BID, and 12 mg BID, respectively. A 90% reduction in SALT was achieved at week 24 by 19.2% and 32.0% in the two active treatment arms (both P<0.0001 vs placebo).
Overall, the study authors rated the efficacy of deuruxolitinib in the treatment of moderate-to-severe alopecia areata as encouraging.
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