TRuE-V1
Trial question
What is the role of ruxolitinib cream in patients with vitiligo?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
56.0% female
44.0% male
N = 330
330 patients (186 female, 144 male).
Inclusion criteria: patients ≥ 12 years of age who had non-segmental vitiligo with depigmentation covering ≤ 10% of total body-surface area.
Key exclusion criteria: complete leukotrichia within any facial lesions; any biologic or experimental therapy within 12 weeks; phototherapy within 8 weeks; immunomodulating treatments within 4 weeks, or topical treatments within 1 week.
Interventions
N=221 ruxolitinib (application of ruxolitinib 1.5% cream BID for 24 weeks with treatment extension through week 52).
N=109 placebo (vehicle cream applied BID for 24 weeks with treatment extension and use of 1.5% ruxolitinib cream through week 52).
Primary outcome
Percentage of patients achieving depigmentation of ≥ 75% in facial vitiligo area scoring index at week 24
29.8%
7.4%
29.8 %
22.4 %
14.9 %
7.5 %
0.0 %
Ruxolitinib
Placebo
Significant
increase ▲
NNT = 4
Significant increase in the percentage of patients achieving depigmentation of ≥ 75% in the facial vitiligo area scoring index at week 24 (29.8% vs. 7.4%; RR 4, 95% CI 1.9 to 8.4).
Secondary outcomes
Significant increase in the percentage of patients achieving depigmentation of ≥ 50% in the facial vitiligo area scoring index at week 24 (51.2% vs. 16.9%; RR 3, 95% CI 1.9 to 4.8).
Significant increase in the percentage of patients achieving depigmentation of ≥ 90% in the facial vitiligo area scoring index at week 24 (15.3% vs. 2.2%; RR 7.3, 95% CI 1.8 to 29.5).
Significant increase in the percentage of patients achieving depigmentation of ≥ 50% in the total body vitiligo area scoring index at week 24 (20.6% vs. 5.1%; RR 4.1, 95% CI 1.6 to 10.5).
Safety outcomes
No significant difference in any adverse event.
Conclusion
In patients ≥ 12 years of age who had non-segmental vitiligo with depigmentation covering ≤ 10% of total body-surface area, ruxolitinib was superior to placebo with respect to the percentage of patients achieving depigmentation of ≥ 75% in the facial vitiligo area scoring index at week 24.
Reference
David Rosmarin, Thierry Passeron, Amit G Pandya et al. Two Phase 3, Randomized, Controlled Trials of Ruxolitinib Cream for Vitiligo. N Engl J Med. 2022 Oct 20;387(16):1445-1455.
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