Ruxolitinib Cream Improves, Stabilizes Total Vitiligo Area Scoring Index

Ruxolitinib cream was well tolerated in adolescents and adults with nonsegmental vitiligo and was associated with mostly improved or stabilized total Vitiligo Area Scoring Index (T-VASI) responses over 52 weeks, according to study findings presented at the 2023 Annual Meeting of the American Academy of Dermatology (AAD), held from March 17 to 21, 2023, in New Orleans, Louisiana.

Study authors conducted 2 multinational randomized, double-blind, vehicle-controlled phase 3 studies (TRuE-V1, ClinicalTrials.gov Identifier: NCT04052425; TRuE-V2, NCT04057573) to evaluate changes or stability in total T-VASI response among patients with vitiligo who used ruxolitinib cream for 52 weeks. A total of 674 patients who were 12 years of age and older with nonsegmental vitiligo and depigmentation covering no more than 10% of total body surface area were recruited for the studies.

Participants were randomly assigned 2:1 to receive either twice-daily 1.5% ruxolitinib cream or vehicle for 24 weeks (ruxolitinib, n=450; vehicle, n=224). All participants could apply 1.5% ruxolitinib cream from weeks 24 through 52. At baseline, mean (SD) facial VASI and T-VASI scores were 0.92 (0.55) and 6.67 (2.05), respectively.

Of the 449 participants who received ruxolitinib and were included in the safety analysis, 401 participants had completed T-VASI assessments at week 12, 10.7% of whom achieved T-VASI50 or better, indicating improvement of at least 50% from baseline. By week 24, 58.4% of participants remained stable in response, 3.5% had a decreased response, and 34.4% had an improved response (22.7% achieved T-VASI50 or better) compared with their week-12 response.

When compared with responses observed in week 24, 48.4% of participants experienced an improved response, 33.7% remained stable, and 3.2% observed a decreased response by week 52. More than 44.4% of participants achieved T-VASI50 or better. The investigators highlighted notable improvements in participants who remained stable and experienced an improved response from weeks 24 to 52, particularly in:

• Stable response
  • T-VASI50 to <75: n=24/65
  • T-VASI75 to <90: n=9/23
  • T-VASI≥90: n=3/3

• Improved response
  • T-VASI25 to <50: n=58/103
  • T-VASI50 to <75: n=32/65
  • T-VASI75 to <90: n=8/23

Investigators found that ruxolitinib cream was well tolerated through 52 weeks of treatment, with 58.6% of patients experiencing at least 1 treatment-emergent adverse event, including COVID-19 (7.3%), application site acne (6.5%), nasopharyngitis (5.8%), and application site pruritus (5.3%). There were no serious adverse events related to use of ruxolitinib, and “there were no clinically significant changes in hemoglobin or platelet levels.”

Investigators concluded, “Adolescents and adults with nonsegmental vitiligo applying ruxolitinib cream largely improved or remained stable in their T-VASI responses from weeks 12 to 24 and from weeks 24 to 52.”