Deuruxolitinib demonstrates efficacy and safety in adults with alopecia areata

Deuruxolitinib demonstrated efficacy and safety in stimulating hair regrowth in adult patients with alopecia areata, according to a study published in Journal of the American Academy of Dermatology.¹

Standard treatments for alopecia include topical, intralesional systemic corticosteroids, and non-corticosteroid systemic immunosuppressive therapies such as methotrexate, cyclosporine, and topical contact immunotherapy. Therapeutic strategies have evolved to focus on Janus kinase (JAK) inhibitors due to their involvement of interferon-g and IL-15 in the pathobiology of alopecia areata.

The FDA approved deuruxolitinib, an oral JAK1 and JAK2 inhibitor, as first-line treatment for adults with moderate to severe alopecia areata in July 2024.² Given the limited availability of effective treatments for hair loss and regrowth, the approval of deuruxolitinib represents a significant advancement for patients.

Researchers conducted the THRIVE-AA1 trial (NCT04518995), a randomized, double-blind, placebo-controlled study at 72 treatment sites in the United States, Canada, and Europe between November 2020 and April 2022.¹ The study included a 28-day screening period, a 24-week treatment period, and an optional open-label extension or 4-week post-treatment follow-up period.

The study enrolled 706 patients randomized to receive 8 mg deuruxolitinib twice daily (n=351), 12 mg deuruxolitinib twice daily (n=215), or placebo (n=140). Participants were predominantly White (68.6%) and female (61.9%), with a median age of 37 years.

Both doses of deuruxolitinib resulted in a higher proportion of patients achieving a Severity of Alopecia Tool (SALT) score less than or equal to 20 after 24 weeks compared to placebo (8 mg, 29.6%; 12 mg, 41.5 % versus placebo, 0.8%). Additionally, key secondary outcomes were achieved with significant improvements between the two doses of deuruxolitinib compared to placebo. At week 24, satisfaction with patient-reported hair outcomes for the 8 mg cohort was 42.1% and for the 12 mg cohort, 53.0%; for the placebo it was 4.7%.

Treatment with deuruxolitinib resulted in significantly higher SALT scores at weeks 8, 12, 16, and 20 compared to placebo. Additionally, at 24 weeks, a greater proportion of patients treated with deuruxolitinib 8 mg (20.8%) or 12 mg (34.5%) twice daily achieved a SALT score of 10 or greater compared to placebo group.

Most reported treatment-emergent adverse events (TEAEs) were mild to moderate in severity, consistent with the known profile of oral JAK inhibitors. Discontinuations due to TEAEs were more common in the deuruxolitinib 8 mg and 12 mg groups, at 2.6% and 2.8%, respectively, compared to 1.4% in the placebo group.

The study was limited by the short duration of the double-blind period and restrictions due to the COVID-19 pandemic. Therefore, future studies are needed to assess long-term safety and effectiveness, as well as the durability of hair regrowth and the potential for recurrence of alopecia areata after treatment discontinuation.

“Treatment with deuruxolitinib resulted in significant hair regrowth on the scalp as early as 8 weeks, which continued throughout the 24-week study period, with patient satisfaction reflecting the observed hair regrowth,” concluded the study authors.

References

1. King B, Senna MM, Mesinkovska NA et al. Efficacy and safety of deuruxolitinib, an oral selective Janus kinase inhibitor, in adults with alopecia areata: results from the phase 3 randomized controlled trial (THRIVE-AA1). J Am Acad Dermatol. Published online July 1, 2024. doi:10.1016/j.jaad.2024.06.097
2. ‌Santoro C. FDA approves deuruxolitinib for alopecia areata. AJMC^®. July 26, 2024. Accessed November 27, 2024.