A post-hoc pooled analysis of the two phase 3 THRIVE-AA1 and THRIVE-AA2 trials demonstrates that the vast majority of those with severe alopecia areata and significant levels of hair regrowth on deuruxolitinib 8 mg BID shifted their self-reported ratings initial dissatisfaction to satisfaction with their scalp hair by 24-weeks.1
These pooled data were presented as a poster titled ‘Change in Patient-Reported Hair Satisfaction During Deuruxolitinib Treatment of Severe Alopecia Areata: Pooled Data from the Phase 3 THRIVE-AA1 and THRIVE-AA2 Trials.’ The poster data were presented during the Dermatology Education Foundation (DERM) 2025 NP/PA CME Conference in Las Vegas, Nevada.
This study was authored by a team of coauthors such as Paradi Mirmirani, MD, from the Permanente Medical Group’s Department of Dermatology in Vallejo, California. Mirmirani and colleagues highlighted the nature of alopecia areata, a chronic autoimmune disease that is marked by partial or complete hair loss.
The investigative team noted in the poster that alopecia can notably impact a patient’s quality of life and emotional well-being given the nature of this disease. The phase 3 THRIVE-AA1 and THRIVE-AA2 analyses were conducted to assess deuruxolitinib’s efficacy as an oral Janus kinase (JAK) 1/2 inhibitor in patients living with severe alopecia areata.
The primary endpoint of of Mirimirani and coauthors’ research was defined as attainment of a Severity of Alopecia Tool (SALT) score of 20 or lower by the 24-week mark. Their pooled analysis of THRIVE-AA1 and THRIVE-AA2 sought to examine any shifts in patient-perceived satisfaction levels with scalp hair using the 5-point Hair Satisfaction Patient Reported Outcome (SPRO) scale.
In their recruitment of participants for their analysis, the team only included those who achieved the primary endpoint of SALT scores ≤20 at Week 24. Those evaluated were also required to have reported at least 50% scalp hair loss at the time of their screening, to be aged 18–65, and to have had an episode of alopecia areata lasting 6 months to 10 years.
Randomization of these patients took place, with those involved being given a placebo, deuruxolitinib 8 mg on a twice-daily basis (BID), or 12 mg BID. Miramirani et al’s analysis was focused on the 8 mg BID arm compared with placebo, specifically. At the 24-week point, the proportion of SPRO responders—which the investigative team defined as subjects with scores of 1, meaning “very satisfied”, or 2, meaning “satisfied”—was assessed.
The team’s analysis was specifically aimed at the change from baseline levels of dissatisfaction (scores of 4 or 5) to satisfaction (scores of 1 or 2) at each of the determined time points. P-values were calculated by Miramirani and colleagues via the Mantel-Haenszel estimate stratified by study.
Among 551 individuals randomized to deuruxolitinib 8 mg BID across both of the THRIVE trials, 31.0% of those involved were shown to have attained the SALT threshold of ≤20 at the 24-week mark and were included in this research.
Only 2 of 247 patients (0.8%) in the placebo arm met this necessary endpoint. Among those who responded to deuruxolitinib, 89.3% were found to have reported satisfaction with their hair at the 24-week mark, whereas none of the placebo responders reported this conclusion. For those involved in the deuruxolitinib 8 mg cohort of the study who were dissatisfied with their scalp hair at the beginning of the analysis, the percentage who reported satisfaction rose over time:
- Week 12: 79.6%
- Week 16: 86.8%
- Week 20: 93.8%
- Week 24: 95.7%
The investigators highlighted that all comparisons between active treatment and placebo at each of the time points assessed were shown to be statistically significant (P < .0001). Overall, this post hoc pooled analysis of phase 3 THRIVE trials showed that over 95% of subjects with significant regrowth of hair when treated with deuruxolitinib 8 mg BID changed from initial dissatisfaction to satisfaction with their scalp hair by 24 weeks.
For any additional information on related data highlighted at DERM 2025, view our latest conference coverage here.
References
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Mirmirani P, Mesinkovska N, Cassella J, et al. Change in Patient-Reported Hair Satisfaction During Deuruxolitinib Treatment of Severe Alopecia Areata: Pooled Data from the Phase 3 THRIVE-AA1 and THRIVE-AA2 Trials. Poster presented at the DERM 2025 NP/PA CME Conference; July 23 – 26, 2025; Las Vegas, Nevada.
