THRIVE-AA1 (deuruxolitinib 8 mg)
Trial question
What is the effect of deuruxolitinib in patients with alopecia areata?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
62.0% female
38.0% male
N = 491
491 patients (306 female, 185 male).
Inclusion criteria: adult patients with alopecia areata.
Key exclusion criteria: recent treatment with medications/agents that could have affected hair regrowth or immune response; known history of moderate-to-severe androgenic alopecia or female-pattern hair loss.
Interventions
N=351 deuruxolitinib (at an oral dose of 8 mg BID).
N=140 placebo (matching placebo BID).
Primary outcome
Percentage of patients achieving Severity of Alopecia Tool score ≤ 20 at week 24
29.6%
0.8%
29.6 %
22.2 %
14.8 %
7.4 %
0.0 %
Deuruxolitinib
Placebo
Significant
increase ▲
NNT = 3
Significant increase in the percentage of patients achieving Severity of Alopecia Tool score ≤ 20 at week 24 (29.6% vs. 0.8%; AD 28.8%, 95% CI 14.41 to 43.19).
Secondary outcomes
Significant increase in Satisfaction of hair Patient-Reported Outcome responders at week 24 (42.1% vs. 4.7%; AD 37.4%, 95% CI 18.71 to 56.09).
Significant increase in the percentage of patients achieving Severity of Alopecia Tool score ≤ 10 at week 24 (20.8% vs. 0%; AD 20.8%, 95% CI 10.4 to 31.2).
Safety outcomes
No significant difference in serious treatment-emergent adverse events.
Conclusion
In adult patients with alopecia areata, deuruxolitinib was superior to placebo with respect to the percentage of patients achieving Severity of Alopecia Tool score ≤ 20 at week 24.
Reference
Brett King, Maryanne M Senna, Natasha A Mesinkovska 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. 2024 Jul 23:S0190-9622(24)02550-7.
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