Two Dosing Regimens of Deuruxolitinib Led to Regrowth of Hair for Alopecia Areata

Maryanne Makredes Senna, MD

Credit: Harvard Health

Significant regrowth of scalp hair among alopecia areata patients after twice-daily use of 8 and 12 mg deuruxolitinib doses may be observed 8 weeks in, according to recent findings, and these results persist throughout a duration of 24 weeks.¹

These new findings were the pooled results of 2 phase 3 trials and they were presented at the 2024 American Academy of Dermatology (AAD) Annual Meeting. The research was led by Maryanne Makredes Senna, MD, assistant professor of dermatology at the Lahey Clinic Medical Center.

Alopecia areata is a chronic autoimmune condition which can lead to substantial quality-of-life reductions as it is characterized by either full or partial hair loss and often recurs in different areas of the body. If untreated, it can also lead to more severe manifestations.

The oral JAK1 and JAK2 inhibitor deuruxolitinib had, prior to Senna and colleagues’ analysis, exhibited substantial hair recovery results when compared to placebo in a phase 2 study that looked at the determination of the drug’s optimal dosages. Senna and the research team’s new pooled findings from THRIVE-AA1 and THRIVE-AA2 trials assessed deuruxolitinib's impact in adults grappling with moderate-to-severe disease.^1,2

In terms of eligibility criteria for the trials, participants had to have been aged 18 - 65 years, with at least 50% hair loss on their scalp and currently facing an episode of alopecia that takes between 6 months - 10 years. Over the course of 24 weeks, these subjects were given either a placebo or deuruxolitinib at doses of 8 mg twice-per-day (BID) or 12 mg BID.¹

The investigators looked at hair loss by evaluating the participants’ Severity of Alopecia Tool (SALT) scores. They determined secondary endpoints to be the proportion of patients achieving a SALT score of 10 or below by the 24-week mark and the relative changes in subjects’ mean SALT scores by the 4, 8, 12, 16, 20, and 24-week marks.

The research team randomized the 1209 study participants fairly evenly from the trials into 3 distinct cohorts: the placebo arm, the 8 mg BID arm, or the 12 mg BID arm. Overall, the team ended up finding that both of the treatment arms with deuruxolitinib demonstrating efficacy in their meeting of the study’s primary endpoint: a SALT score of 20 or lower.

By the 24-week mark, the investigators found that 31.0% and 40.3% of the individuals featured in the 8mg BID and 12 mg BID arms, respectively, reported their achievement of this endpoint, compared to 0.8% in the placebo arm (P < .0001). The team also noted differences from those in the placebo group for both deuruxolitinib doses as early as the eight week (P < .0005).

Additionally, the research team reported that 22.5% and 31.6% of the participants placed into the 8 and 12 mg cohorts, respectively, were shown to have a SALT score of 10 or lower by the 24-week mark as opposed to 0% among those given the placebo (P < .0001). The team identified distinctions in the relative changes observed in SALT scores from the point of baseline for both treatment dosing regimens, compared to placebo as early as the fourth week (P < .01).

Overall, substantial regrowth of hair in both dosing regimens of deuruxolitinib were shown by the investigators to have occurred by 8 weeks, and this was also found to have continued through the 24-week course of both trials. Senna and colleagues expressed that the results indicate clinically significant efficacy of the treatment for moderate-to-severe alopecia areata.

References

1. ^{Efficacy of the Oral JAK1/JAK2 Inhibitor Deuruxolitinib in Adult Patients With Moderate to Severe Alopecia Areata: Pooled Results From the Multinational, Double-Blind, Placebo-Controlled THRIVE-AA1 and THRIVE-AA2 Phase 3 Trials. Presentation (Poster #51840) at the American Academy of Dermatology (AAD) 2024 Annual Meeting. March 2024.}
2. ^{Butera A. Significant Scalp Hair Regrowth in Alopecia Areata Following CTP-543 Treatment. HCPLive. June 7, 2022. https://www.hcplive.com/view/scalp-hair-regrowth-alopecia-areata-ctp-543. Date accessed: March 11, 2024.}