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Improvements in facial 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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75% improvement in facial vitiligo repigmentation (F-VASI75) was achieved by ~1 in 2 patients who used Opzelura® for 52 weeks (secondary endpoint)2

In the TRuE-V1 study, the primary endpoint, F-VASI75 response at Week 24 was achieved by significantly more patients on Opzelura® (66/221) than on the vehicle (8/109) (P<0.001). Scores on the F-VASI range from 0 to 3, with higher scores indicating a greater area of facial depigmentation.

After 52 weeks, 1 in 2 patients (91/173) achieved a 75% improvement in facial vitiligo repigmentation with Opzelura®.

F-VASI75 results in TRuE-V2 were similar to TRuE-V1.2

F-VASI75 responses in TRuE-V12

F-VASI75 responses in TRuE-V1

Adapted from Rosmarin et al. 2022.

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Opzelura® treatment vs vehicle, patients achieving F-VASI75 (%) at Week 24, and 52. After 24 weeks patients on the vehicle were switched to Opzelura®. F-VASI, Facial Vitiligo Area Scoring Index.

F-VASI75 results: supporting context

A significant improvement in F-VASI75 was observed at Week 24 with Opzelura® (29.8%; 66/221) vs the vehicle cream (7.4%; 8/109) in TRuE-V1, achieving the study’s primary endpoint (P<0.001).2

A numerical increase in the proportion of patients who achieved F-VASI75 at Week 52 was also observed with Opzelura® (52.6%; 91/173) vs the vehicle cream to Opzelura® crossover arm (26.8%; 22/82) in TRuE-V1.2

Results were similar in TRuE-V2. F-VASI75 was 30.9% (69/222) with Opzelura® vs 11.4% (12/109) with the vehicle cream at Week 24 (P<0.001); and 48.0% (85/177) with Opzelura® vs 29.6% (24/81) in the crossover arm at Week 52.2

Individual examples of Opzelura® facial repigmentation results over time: up to 52 weeks3

F-VASI75 example one - Baseline F-VASI75 example one - Week 12 F-VASI75 example one - Week 24
F-VASI75 example two - Baseline F-VASI75 example two - Week 12 F-VASI75 example two - Week 24
F-VASI75 example three - Baseline F-VASI75 example three - Week 24 F-VASI75 example three - Week 52
F-VASI75 example four - Baseline F-VASI75 example four - Week 24 F-VASI75 example four - Week 52

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 of vitiligo on the face achieved can vary individually over the course of treatment.

More than 1 in 4 patients demonstrated 50% facial vitiligo repigmentation (F-VASI50, secondary endpoint) at 12 weeks with Opzelura®2

After 12 weeks, more than 1 in 4 patients demonstrated a rapid initial response of 50% facial repigmentation with Opzelura® (N=221) in the TRuE-V1 study.2

After 24 weeks, ~1 in 2 patients (113/221) achieved 50% or more facial vitiligo repigmentation with Opzelura® in TRuE-V1 (P<0.001).2

In TRuE-V1 at Week 52, ~3 in 4 patients (n=173) achieved a 50% or more improvement in facial vitiligo repigmentation (F-VASI50) compared to baseline with Opzelura®.2

F-VASI50 results in TRuE-V2 were similar to TRuE-V1.2

F-VASI50 responses in TruE-V12

F-VASI50 responses in TRuE

Adapted from Rosmarin et al. 2022.

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Opzelura® treatment vs vehicle, F-VASI50 repigmentation rate (%) at Week 12, 24 and 52. After 24 weeks patients on the vehicle were switched to Opzelura®.

F-VASI50 results: supporting context

An increase in the proportion of patients who achieved F-VASI50 at Week 12 was observed with Opzelura® (26.0%; N=221) vs vehicle cream (11.0%; N=109) in TRuE-V1.2

A significant (P<0.001) improvement in F-VASI50 was observed at Week 24 with Opzelura® (51.2%; 113/221) vs vehicle cream (16.9%; 18/109) in TRuE-V1. 2

The proportion of patients who achieved F-VASI50 at Week 52 was 75.1% with Opzelura® (n=173) vs 56.1% for vehicle cream to Opzelura® crossover (n=82) in TRuE-V1.2

The results were similar in TRuE-V2. F-VASI50 was 32.2% with Opzelura® (N=222) vs 16.7% with vehicle (N=109) at Week 12; 51.4% with Opzelura® (114/222) vs 20.9% with vehicle (23/109) at Week 24 (P<0.001); 74.0% with Opzelura® (n=177) vs 49.4% in the crossover arm (n=81) at Week 52.2

Individual examples of Opzelura® facial repigmentation results over time: up to 24 weeks3

F-VASI50 example one - Baseline F-VASI50 example one - Week 12 F-VASI50 example one - Week 24
F-VASI50 example two - Baseline F-VASI50 example two - Week 12 F-VASI50 example two - Week 24

The above images show different treatment courses with Opzelura® from the TruE-V approval studies over a period of up to 24 weeks. The degree of repigmentation of vitiligo on the face achieved can vary individually over the course of treatment.

Facial vitiligo repigmentation of 90% (F-VASI90, secondary endpoint) was achieved by >30% of patients after 1 year2

At 1 year, 90% or more facial vitiligo repigmentation was achieved in ~1 in 3 patients (n=173).2

In the TRuE-V1 study, F-VASI90 response at Week 24 was achieved by significantly more patients on Opzelura® (15.3%; 34/221) than on the vehicle (2.2%; 2/109) (P<0.01).2

F-VASI90 responses in TRuE-V12

F-VASI90 responses in TRuE

Adapted from Rosmarin et al. 2022.

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Opzelura® treatment vs vehicle, F-VASI90 repigmentation rate (%) at Week 24 and 52. After 24 weeks patients on the vehicle were switched to Opzelura®.

F-VASI90 results: supporting context

An increase in the proportion of patients who achieved F-VASI90 at Week 52 was observed with Opzelura® (32.9%; n=173) vs vehicle cream to Opzelura® crossover (12.2%; n=82) in TRuE-V1.2

The results were similar in TRuE-V2. F-VASI90 was 16.3% (n=222) with Opzelura® vs 1.3% (n=109) with the vehicle cream at Week 24; 27.7% (n=177) with Opzelura® vs 16.0% (n=81) in the crossover arm at Week 52.2

Individual examples of Opzelura® results over time on facial repigmentation: F-VASI903

F-VASI90 example one - Baseline F-VASI90 example one - Week 24 F-VASI90 example one - Week 52
F-VASI90 example two - Baseline F-VASI90 example two - Week 24 F-VASI90 example two - Week 52
F-VASI90 example three - Baseline F-VASI90 example three - Week 12 F-VASI90 example three - Week 24
F-VASI90 example four - Baseline F-VASI90 example four - Week 24 F-VASI90 example four - Week 52

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 of vitiligo on the face achieved can vary individually over the course of treatment.

Patients reported ‘less noticeable’ vitiligo with Opzelura® vs vehicle cream2

Significantly more patients reported ‘a lot less noticeable’ or ‘no longer noticeable’ vitiligo with Opzelura® vs vehicle at 24 weeks, based on the Vitiligo Noticeability Scale (VNS) responses in TRuE-V1. 2,4

VNS explained

The VNS is a validated measure of patient-reported outcome (PRO) measure that assesses patient-perceived treatment success by rating the noticeability of vitiligo lesions after treatment.4

Patients are asked to compare their vitiligo before and after treatment, and asked to rate noticeability as either:

  1. More noticeable
  2. As noticeable
  3. Slightly less noticeable
  4. A lot less noticeable
  5. No longer noticeable

A score of 4 or 5 is considered to be a response.

TRuE-V1 noticeability results2

TRuE V1 noticeability results

Adapted from Rosmarin et al. 2022.

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In the TRuE-V1 pivotal study, significantly more patients treated with Opzelura® achieved a VNS response (rated as “slightly less noticeable” or “no longer noticeable”) at Week 24 compared to vehicle. After 24 weeks patients on the vehicle were switched to Opzelura®.

VNS results: supporting context

Significantly more patients reported a vitiligo noticeability score (VNS) response (‘a lot less noticeable’ or ‘no longer noticeable’) with Opzelura® vs vehicle cream, 24.5% (54/221) vs 3.3% (4/109), respectively at Week 24 in TRuE-V1 (P<0.001).2 More patients also achieved a VNS response at Week 52 with Opzelura® (39.9%; n=173) vs the vehicle cream to Opzelura® crossover arm (19.5%; n=82) in TRuE-V1.2

F-PaGIC-V

Numerically more patients reported an F-PaGIC-V of ‘very much improved’ or ‘much improved’ with Opzelura® (45.1%; n=195) vs vehicle (7.8%; n=90) at 24 weeks.2

[The Facial Patient Global Impression of Change for Vitiligo (F-PaGIC-V) is a seven-point scale to describe patient-perceived change in vitiligo.]

Colour matching

Numerically more patients reported ‘good’ or better colour matching at 24 weeks with Opzelura® (76.9%; n=195) compared with vehicle (43.3%; n=90).2

[Colour matching was measured on a five-point scale: ‘Excellent’, ‘Very good’, ‘Good’, ’Poor’, and ‘Very poor’.]

Opzelura® is contraindicated during pregnancy and breastfeeding.

*Patient quotes are fictional.

Abbreviations

CI, confidence interval; F-PaGIC-V, Facial Patient Global Impression of Change for Vitiligo; F-VASI, Facial Vitiligo Scoring Index; F-VASI50, ≥50% reduction from baseline in Facial Vitiligo Area Scoring Index; F-VASI75, ≥75% reduction from baseline in Facial Vitiligo Area Scoring Index; F-VASI90, ≥90% reduction from baseline in Facial Vitiligo Area Scoring Index; PRO, patient-reported outcomes; RR, relative risk; TRuE-V, topical ruxolitinib evaluation in vitiligo study; VASI, Vitiligo Area Scoring Index; VNS, Vitiligo Noticeability Scale.

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. Incyte Biosciences International Sarl. Data on File.
  4. Batchelor JM, et al. Br J Dermatol. 2016;174(2):386–94.

UNITED KINGDOM
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REPUBLIC OF IRELAND
Adverse events should be reported. Reporting forms and information can be found at: HPRA Pharmacovigilance website: www.hpra.ie Adverse events should also be reported to Incyte by calling 00-800-0002-7423.