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Improvements in body vitiligo repigmentation were seen with Opzelura® in two pivotal studies

Opzelura® is indicated for the treatment of non-segmental vitiligo with facial involvement in adults and adolescents from 12 years of age1

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~1 in 2 patients achieved ≥50% body repigmentation at 1 year2

The vitiligo area scoring index (VASI) is a validated quantitative scale measuring the extent of vitiligo involvement as a % of affected body surface area (BSA) multiplied by degree of depigmentation.3–6

T-VASI refers to the total body area vitiligo area scoring index, ranging from a score of 0% to 100%, with higher scores of 100% indicating no pigment being present, and 0% indicating no depigmentation being present. T-VASI includes the head/neck including the scalp; trunk, including genitalia; upper limbs, including axillae; hands; lower limbs, including buttocks; and feet.2

In the TRuE-V1 study, Opzelura® significantly improved body repigmentation (T-VASI50) vs the vehicle cream (P=0.002).1 After 52 weeks approximately 1 in 2 patients (92/173) achieved 50% or more body repigmentation.2

T-VASI50 responses in TRuE-V1 (secondary endpoint)2

F-VASI75-responses-results-in-TRuE-V1

Adapted from Rosmarin et al. 2022.

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Opzelura® vs vehicle, T-VASI50 repigmentation rate (%) at Week 24, including crossover at week 52. After 24 weeks patients on the vehicle were switched to Opzelura®.

T-VASI50 results: supporting context

A significant improvement in T-VASI50 was observed at Week 24 with Opzelura® (20.6%; 46/221) vs vehicle cream (5.1%; 6/109) in TRuE-V1 (P=0.002).2 A numerical increase in the proportion of patients who achieved T-VASI50 at Week 52 was observed with Opzelura® (53.2%; 92/173) vs vehicle cream to Opzelura® crossover (31.7%; 26/82) in TRuE-V1.2

T-VASI50 response results in TRuE-V1 were comparable to those in TRuE-V2. Similar values of 23.9% (53/222) with Opzelura® vs 6.8% (7/109) with the vehicle at Week 24, and 49.2% (87/177) with Opzelura® vs 22.2% (18/81) in the crossover arm at Week 52.2

Individual examples of Opzelura® body repigmentation results over time: up to 52 weeks7

Patient 15: Vitiligo score and Opzelura® results - Baseline
Baseline
Head and neck VASI score: 1
Patient 15: Vitiligo score and Opzelura® results - Week 24
Week 24
Head and neck VASI score: 0.01
99% neck repigmentation from baseline
Patient 15: Vitiligo score and Opzelura® results - Week 52
Week 52
Head and neck VASI score: 0.01
99% neck repigmentation from baseline

Patient 15: Vitiligo score and Opzelura® results

Patient 16: Vitiligo score and Opzelura® results - Baseline
Baseline
Lower extremities VASI score: 2
Patient 16: Vitiligo score and Opzelura® results - Week 24
Week 24
Lower extremities VASI score: 0.2
90% lower extremities repigmentation from baseline
Patient 16: Vitiligo score and Opzelura® results - Week 52
Week 52
Lower extremities VASI score: 0.2
90% lower extremities repigmentation from baseline

Patient 16: Vitiligo score and Opzelura® results

Patient 18: Vitiligo score and Opzelura® results - Baseline
Baseline
Upper extremities VASI score: 1.62
Patient 18: Vitiligo score and Opzelura® results - Week 24
Week 24
Upper extremities VASI score: 0.3
81.5% upper extremities repigmentation from baseline
Patient 18: Vitiligo score and Opzelura® results - Week 52
Week 52
Upper extremities VASI score: 0.1
93.8% upper extremities repigmentation from baseline

Patient 18: Vitiligo score and Opzelura® results

Patient 20: Vitiligo score and Opzelura® results - Baseline
Baseline
T-VASI score: 8.73
Hand VASI score: 2
Patient 20: Vitiligo score and Opzelura® results - Week 24
Week 24
T-VASI score: 6.15
Hand VASI score: 1.5
25% hand repigmentation from baseline
Patient 20: Vitiligo score and Opzelura® results - Week 52
Week 52
T-VASI score: 3.45
Hand VASI score: 1
50% hand repigmentation from baseline

Patient 20: Vitiligo score and Opzelura® results

The above images show different treatment courses with Opzelura® from the TruE-V approval studies over a period of up to one year. The degree of repigmentation achieved can vary individually over the course of treatment.

Abbreviations

T-VASI, Total Vitiligo Area Scoring Index; T-VASI50, ≥50% reduction from baseline in Total Vitiligo Area Scoring Index; TRuE-V, topical ruxolitinib evaluation in vitiligo study; VASI, Vitiligo Area Scoring Index.

References

  1. Opzelura® (ruxolitinib cream) Summary of Product Characteristics. Incyte Biosciences UK Ltd. November 2023.
  2. Rosmarin D, et al. N Engl J Med. 2022;387(16):1445–1455.
  3. Rosmarin D, et al. Lancet. 2020;396(10244):110–120.
  4. van Geel N, et al. J Invest Dermatol. 2016;136(5):978–984.
  5. DermNet. Vitiligo: Causes, Types, and Treatment. Dermnetnz.org. Published 2022. Available at: https://dermnetnz.org/topics/vitiligo (Accessed March 2024).
  6. Hamzavi I, et al. Arch Dermatol. 2004;140(6):677–683.
  7. Incyte Biosciences International Sarl. Data on File.

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REPUBLIC OF IRELAND
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