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Dose optimization of deuruxolitinib in adults with alopecia areata: A phase 2 randomized trial
Brett King1, Steven Kempers2, Natasha A Mesinkovska3
1Dermatology Physicians of Connecticut, Fairfield, CT, USA.
Background:
The autoimmune disorder alopecia areata (AA) results in patchy or complete hair loss.
Objective:
To evaluate the efficacy and safety of the Janus kinase 1/2 inhibitor deuruxolitinib dosed 8 mg twice daily (BID) or 16 mg once daily (QD) in adults with severe AA.
Methods:
In this phase 2 study (NCT03811912), patients were randomized to deuruxolitinib 8 mg BID or 16 mg QD. Primary endpoint was relative change from baseline in Severity of Alopecia Tool (SALT) score at Week 24. Safety included treatment-emergent adverse events (TEAEs).
Results:
The study included 57 patients (mean age, 40.1 years; 66.7% female). At Week 24, the mean relative change from baseline in SALT score was greater with deuruxolitinib 8 mg BID (46.4 [90% confidence interval [CI], 34.3-58.4]) vs 16 mg QD (18.0 [90% CI, 7.6-28.4]) and a greater proportion of patients receiving deuruxolitinib 8 mg BID vs 16 mg QD achieved SALT score ≤20 and ≤10. TEAEs were mild or moderate in severity.
Limitations:
This study had a small sample size. Larger studies will further evaluate the efficacy and safety of deuruxolitinib.
Conclusion:
Deuruxolitinib 8 mg BID was associated with greater improvements in scalp hair regrowth vs deuruxolitinib 16 mg QD.
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