Ruxolitinib 1.5% Cream in Nonsegmental Vitiligo: TRuE-V1 and TRuE-V2 Phase 3 Results

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Key Takeaways

  • Two parallel phase 3 RCTs (TRuE-V1/V2) showed superiority vs vehicle on F-VASI at week 24, with continued gains to week 52 on open-label extension.
  • Best responses on face/neck; total body (T-VASI) improves more slowly.
  • Safety profile favorable: mostly mild application-site AEs; low systemic exposure with appropriate BSA limits.
  • Mechanistic fit with IFN-γ/JAK-STAT pathway; combination with NB-UVB is under exploration for speed/magnitude.

Abstract

Ruxolitinib 1.5% cream, a topical JAK1/2 inhibitor, met primary facial repigmentation endpoints in two phase 3 trials (TRuE-V1/V2). Here we outline randomized design, F-VASI/T-VASI outcomes, responder thresholds, durability into the open-label period, and safety considerations including body-surface-area limits.

Trial Design

Table 1. Core design features.
Element Details
Type Two multicenter, randomized, double-blind, vehicle-controlled phase 3 trials
Population Adolescents & adults with nonsegmental vitiligo; facial involvement required
Arms Ruxolitinib 1.5% cream vs vehicle, BID application within BSA cap
Duration Double-blind 24 weeks → open-label to week 52

Endpoints

  • Primary: Proportion achieving F-VASI50 at week 24.
  • Secondary: F-VASI75, change in T-VASI, Patient/Physician Global, QoL scales.
  • Exploratory: Earlier facial island formation, Wood’s-lamp margin contraction.

Efficacy Results

Table 2. Outcome framework (fill with study numerics).
Outcome (wk 24) Ruxolitinib Vehicle Interpretation
F-VASI50 responders — — Superiority on active
F-VASI75 responders — — Higher on active
T-VASI % change — — Improvement vs vehicle

Facial repigmentation typically begins with perifollicular islands by weeks 6–10, accumulating through week 24.

Durability & Extension

  • Open-label extension to week 52 showed continued gains in facial and total-body endpoints for initial responders and vehicle cross-overs.
  • Maintenance strategies include continued BID or taper after plateau; relapse risk appears lower with ongoing use.

Safety

Table 3. Safety profile.
Adverse event Pattern Notes
Application-site acne/erythema/pruritus Mild–moderate Often transient
Systemic JAK AEs Low with topical & BSA limits Monitor per label cautions
Lab abnormalities Uncommon Check if clinically indicated

Practical Use

  • Apply BID thin layer to lesions within label BSA cap; avoid occlusion.
  • Strongest utility on face/neck; consider adjunct NB-UVB for broader disease or slower T-VASI change.
  • Set expectations: facial endpoints improve first; body follows more slowly.

Limitations

Strict inclusion criteria and BSA caps limit generalizability to extensive disease; long-term off-drug durability data remain limited.

References

  1. Phase 3 TRuE-V1 and TRuE-V2 publications and extension reports describing F-VASI/T-VASI outcomes and safety.
  2. Mechanistic studies linking IFN-γ/CXCL10 signaling to JAK-STAT blockade in vitiligo.
  3. Real-world series on ruxolitinib cream use and combinations with phototherapy.
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