Deuruxolitinib, an oral Janus kinase (JAK) inhibitor, has shown promising results in stimulating hair regrowth among adult patients with alopecia areata. The recent FDA approval of deuruxolitinib marks a significant advancement in the treatment of this condition, where effective treatments have been limited.
The THRIVE-AA1 trial (NCT04518995), a randomized, double-blinded, placebo-controlled study, evaluated the efficacy and safety of deuruxolitinib across 72 treatment sites in the US, Canada, and Europe. The study enrolled 706 patients who were randomized to receive deuruxolitinib 8 mg twice daily (n = 351), deuruxolitinib 12 mg twice daily (n = 215), or placebo (n = 140).
Efficacy Outcomes
Both doses of deuruxolitinib resulted in significantly higher proportions of patients achieving a Severity of Alopecia Tool (SALT) score less than or equal to 20 after 24 weeks compared to placebo. Specifically, 29.6% of patients in the 8 mg group and 41.5% in the 12 mg group achieved this outcome, compared to only 0.8% in the placebo group. Key secondary outcomes also showed significant improvements with both deuruxolitinib doses compared to placebo. At week 24, patient-reported satisfaction with hair regrowth was 42.1% in the 8-mg cohort and 53.0% in the 12-mg cohort, compared to 4.7% for placebo.
Treatment with deuruxolitinib also resulted in significantly higher SALT scores at weeks 8, 12, 16, and 20 compared with placebo. Furthermore, at 24 weeks, a greater proportion of patients treated with 8-mg (20.8%) or 12-mg (34.5%) twice-daily deuruxolitinib achieved a SALT score of 10 or higher compared with the placebo group.
Safety Profile
Most treatment-emergent adverse events (TEAEs) reported were of mild to moderate severity, consistent with the known profile of oral JAK inhibitors. Discontinuations due to TEAEs were more frequent in the 8-mg and 12-mg deuruxolitinib groups at 2.6% and 2.8%, respectively, compared with 1.4% in the placebo group.
Expert Commentary
According to the study authors, "Treatment with deuruxolitinib resulted in significant scalp hair regrowth as early as 8 weeks, which continued throughout the 24 week study period, with patient satisfaction reflecting the hair regrowth observed."
Considerations
The study was limited by the short duration of the double-blind period and restrictions due to the COVID-19 pandemic. Future studies are necessary to assess long-term safety and efficacy, as well as the durability of hair regrowth and the potential for alopecia areata recurrence after treatment discontinuation.
