Treatment with deuruxolitinib, an oral Janus kinase 1/2 inhibitor, resulted in significant hair regrowth on the scalp for 24 weeks among patients with severe alopecia areata (AA), according to the two phase III THRIVE-AA1 and -AA2 trials presented at AAD 2026.
This pooled analysis consisted of 867 patients (mean age 39 years) with AA and having ≥50 scalp hair loss. Participants were randomly assigned to receive either deuruxolitinib 8 mg twice daily (n=600) or placebo (n=267) over a 24-week treatment period. The study’s primary endpoint was the proportion of patients achieving an absolute Severity of Alopecia Tool (SALT) score ≤20 at week 24.
At baseline, the mean SALT score was 86.8 in the deuruxolitinib group and 88.6 in the placebo group, with more than half of the participants having complete or near-complete scalp hair loss (SALT score ≥95; 58.7 percent and 58.8 percent, respectively).
The deuruxolitinib group demonstrated a statistically significant decrease in mean SALT score as early as week 8 (78.3 vs 87.2; p<0.0001), which was sustained through week 24 (52.3 vs 88.6; p<0.0001) compared with the placebo group.
By week 24, a significantly higher proportion of deuruxolitinib-treated patients achieved a SALT score of ≤20, indicating a clinically meaningful improvement in scalp hair regrowth from baseline than placebo-treated patients (31 percent vs 0.8 percent; p<0.0001). [AAD 2026, abstract 74643]
Post hoc analysis
In the post hoc analysis, a higher percentage of patients treated with deuruxolitinib compared with placebo achieved an absolute SALT score of ≤30 at weeks 8 (4.5 percent vs 1.9 percent; p<0.05) and 24 (37.2 percent vs 2.8 percent; p<0.05).
Significantly more deuruxolitinib recipients also achieved SALT scores of ≤40 and ≤50 at week 8 (10.8 percent vs 3.4 percent and 17.9 percent vs 6.5 percent, respectively; p<0.0001 for both), which continued to improve until week 24 (41.2 percent vs 4 percent and 49.9 percent vs 6.9 percent; p<0.0001 for both).
From baseline to week 24, a higher proportion of patients on deuruxolitinib experienced clinically significant improvements in SALT scores (≥30 percent to 100 percent incremental improvements) than those on placebo (≥30 percent: 53.2 percent vs 6.5 percent; ≥50 percent: 43.4 percent vs 3.2 percent; ≥75 percent: 30.7 percent vs 0 percent; ≥90 percent: 20.3 percent vs 0 percent; and 100 percent:7.6 percent vs 0 percent; p≤0.0001 for all).
“Overall, this pooled analysis of the THRIVE-AA1 and -AA2 studies demonstrated that deuruxolitinib 8 mg twice daily was associated with improvements in hair regrowth as shown using SALT responder thresholds and incremental improvements in SALT scores from baseline through week 24,” according to the researchers.