TRuE-V2
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
50.0% female
50.0% male
N = 343
343 patients (172 female, 171 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=228 ruxolitinib (application of ruxolitinib 1.5% cream BID for 24 weeks with treatment extension through week 52)
N=115 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
30.9
11.4
30.9 %
23.2 %
15.4 %
7.7 %
0.0 %
Ruxolitinib
Placebo
Significant
increase ▲
NNT = 5
Significant increase in the percentage of patients achieving depigmentation of ≥ 75% in the facial vitiligo area scoring index at week 24 (30.9% vs. 11.4%; RR 2.7, 95% CI 1.5 to 4.9)
Secondary outcomes
Significant increase in the percentage of patients achieving depigmentation of ≥ 50% in the facial vitiligo area scoring index at week 24 (51.4% vs. 20.9%; RR 2.5, 95% CI 1.6 to 3.7)
Significant increase in the percentage of patients achieving depigmentation of ≥ 90% in the facial vitiligo area scoring index at week 24 (16.3% vs. 1.3%; RR 13.1, 95% CI 1.9 to 90.2)
Significant increase in the percentage of patients achieving depigmentation of ≥ 50% in the total body vitiligo area scoring index at week 24 (23.9% vs. 6.8%; RR 3.5, 95% CI 1.7 to 7.5)
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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