THRIVE-AA2: Deuruxolitinib Improves Week 24 SALT20 Response

Key Takeaways

• THRIVE-AA2 enrolled adults aged 18 to 65 years with severe chronic alopecia areata and assigned 517 participants to two deuruxolitinib dose groups or placebo.
• Both deuruxolitinib regimens were associated with higher Week 24 SALT20 response than placebo on the primary endpoint.
• Investigators described mostly mild-to-moderate drug-related adverse events.

This phase 3, randomized, double-blind, placebo-controlled, multicenter trial enrolled adults aged 18 to 65 years with a SALT score of at least 50 and an episode lasting at least 6 months at screening. Investigators randomized 517 patients in a 1:2:1 scheme to deuruxolitinib 12 mg twice daily, deuruxolitinib 8 mg twice daily, or placebo. The primary endpoint was the proportion of patients achieving SALT20 at Week 24, defined as a SALT score of 20 or lower at that assessment.

At week 24, SALT20 was achieved by 33.0% with deuruxolitinib 8 mg twice daily, 38.3% with 12 mg twice daily, and 0.8% with placebo. Both active-dose comparisons versus placebo were statistically superior (P < .0001 for each comparison).

The authors describe deuruxolitinib as well tolerated during the reported study period and note that most study drug-related treatment-emergent adverse events were mild or moderate.