THRIVE-AA1 (deuruxolitinib 12 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 = 355
355 patients (220 female, 135 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=215 deuruxolitinib (at an oral dose of 12 mg BID).
N=140 placebo (matching placebo BID).
Primary outcome
Percentage of patients achieving Severity of Alopecia Tool score ≤ 20 at week 24
41.5%
0.8%
41.5 %
31.1 %
20.8 %
10.4 %
0.0 %
Deuruxolitinib
Placebo
Significant
increase ▲
NNT = 2
Significant increase in the percentage of patients achieving Severity of Alopecia Tool score ≤ 20 at week 24 (41.5% vs. 0.8%; AD 40.7%, 95% CI 20.36 to 61.04).
Secondary outcomes
Significant increase in Satisfaction of hair Patient-Reported Outcome responders at week 24 (53% vs. 4.7%; AD 48.3%, 95% CI 24.16 to 72.44).
Significant increase in the percentage of patients achieving Severity of Alopecia Tool score ≤ 10 at week 24 (34.5% vs. 0%; AD 34.5%, 95% CI 17.26 to 51.74).
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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