Skip to content

Opzelura® (ruxolitinib) cream - the first and only approved therapy for the treatment of non-segmental vitiligo1,2

Opzelura® is indicated for the treatment of non-segmental vitiligo with facial involvement in adults and adolescents from 12 years of age 1

Opzelura® – redefining the future

123
Quotation mark

Can I talk to my doctor about the first approved treatment option for vitiligo? Quotation mark

Now you can.*1

Opzelura® topical cream is the first treatment to receive an approved indication for use in non-segmental vitiligo with facial involvement in adults and adolescents aged 12 years and older.1,2

Currently available to private patients in the UK, Incyte is working to ensure that eligible patients will be able to access Opzelura® on the NHS.

If you have private patients who are eligible to receive Opzelura®, you can get in touch via the link below. If you are a GP and have a patient with suspected vitiligo, please refer them to a secondary care specialist or a GP with Extended Role (GPwER).

Get in touch

Vitiligo’s effect is not just skin deep

Group of patients

Often dismissed as a cosmetic, insignificant disease, in reality vitiligo patients experience a considerable psychological burden, which often impacts their mental health.5-8 Additionally, vitiligo is associated with various autoimmune comorbidities.9-11

There is currently an unmet need for treatment options for patients with vitiligo. Until Opzelura® was approved, no licensed treatments were available to aid repigmentation of the skin.5

Opzelura® – the first approved treatment for non-segmental vitiligo1,2

Opzelura®, which contains the active substance ruxolitinib, is the first approved topical JAK 1/2 inhibitor for vitiligo and has been approved for use in Europe and the UK.1,2

Opzelura® works by inhibiting JAK-STAT signalling to address the three vitiligo treatment goals:4

Infographic showing how Opzelura can help people with vitiligo to halt depigmentation

Halt depigmentation

Infographic showing how Opzelura can help people with vitiligo to induce repigmentation

Induce repigmentation

Infographic showing how Opzelura can help people with vitiligo to prevent relapse.

Prevent relapse

  • Halting depigmentation – by selectively binding to JAK1 and JAK2
  • Inducing repigmentation – melanocytes migrate from hair follicles and lesion edges
  • Preventing relapses – selective JAK1 binding inhibiting signal transmission by IL-15

Opzelura® is the only approved treatment to aid quality repigmentation of non-segmental vitiligo.2

Significant repigmentation seen with Opzelura® in pivotal trials3

Opzelura® efficacy was examined in two randomised studies, TRuE-V1 and TRuE-V2, with results showing significant repigmentation over a long period of time.3

Facial repigmentation

repigmentation results 52 weeks

The TRuE-V1 study achieved the primary endpoint and showed significant improvement in F-VASI75 with Opzelura® vs a vehicle cream after 24 weeks [29.8% (66/221) vs 7.4% (8/109); P<0.001].3

After 52 weeks, around 30% of patients (n=173) achieved ≥90% facial repigmentation (F-VASI) with Opzelura® and one in two patients (91/173) achieved a 75% improvement in facial pigmentation.3

Body repigmentation

After 52 weeks around 50% of patients achieved ≥50% overall body repigmentation (T-VASI) with Opzelura® (92/173).3

Opzelura body repigmentation results from baseline to week 52.
Images shown are TRuE-V1 and TRuE-V2 study participants. Individual results including level of repigmentation and time to outcome, may vary. See Prescribing Information and additional safety information.

Opzelura® cream is convenient to apply1

Opzelura® cream is applied twice a day to the depigmented skin areas up to a maximum of 10% of the body surface area (BSA).1

Opzelura® is a non-greasy formula and can be applied to sensitive areas of the skin† – making Opzelura® application convenient for your patients.1

Opzelura® was generally well tolerated in clinical trials3

In the TRuE-V1 and TRuE-V2 studies, Opzelura® showed a favourable safety profile with the most common side effect being acne at application site.1

During the studies, no serious adverse events were considered to be related to Opzelura®.3

Your patients, vitiligo and Opzelura®

It is important to have conversations with your vitiligo patients to discuss current available vitiligo treatments, and the psychosocial impact that vitiligo may be having on their lives.

Effective vitiligo management often extends beyond medication alone. Prioritising shared decision-making and meaningful patient conversations is essential; this personalised approach ensures that treatment goals align with the vitiligo patients' preferences, lifestyles, and expectations.13

Stay informed about Opzelura® and vitiligo

Visit our Stay informed page if you would like to receive email communications from Incyte containing information and education relevant to your clinical practice.

Incyte
dermatology

Opzelura® is manufactured by Incyte, a biopharmaceutical company on a mission to find answers for patients by following the science. Incyte is committed to discovering and developing innovative dermatology treatments to bring solutions to patients in need.

Opzelura® is contraindicated during pregnancy and breastfeeding.

*Patient quotes are fictional.

†Opzelura® is not for ophthalmic, oral, or intravaginal use. In cases of accidental exposure to the eyes or mucous membranes, the cream should be thoroughly wiped off and/or rinsed with water.

Abbreviations

BSA, body surface area; F-VASI, Facial Vitiligo Area Scoring Index; T-VASI, Total Vitiligo Area Scoring Index.

References

  1. Opzelura® (ruxolitinib cream) Summary of Product Characteristics. Incyte Biosciences UK Ltd. November 2023.
  2. Hospital Pharmacy Europe. Ruxolitinib cream gains MHRA approval for non-segmental vitiligo. Available at: https://hospitalpharmacyeurope.com/clinical-zones/dermatology/ruxolitinib-cream-gains-mhra-approval-for-non-segmental-vitiligo/ (Accessed March 2024).
  3. Rosmarin D, et al. N Engl J Med. 2022;387(16):1445–1455.
  4. Passeron T. Dermatol Clin. 2017;35(2):163–170.
  5. Bergqvist C, et al. J Dermatol. 2021;48(3):252–270.
  6. Krüger C, et al. Acta Derm Venereol. 2015;95(5):553–558.
  7. Bibeau K, et al. Presented at: Maui Derm for Dermatologists, 24 January 2022, Maui, HI.
  8. Phan K, et al. Pigment Int. 2022;9(2):127–130.
  9. Hadi A, et al. J Am Acad Dermatol. 2020;82(3):628–633.
  10. Gill L, et al. J Am Acad Dermatol. 2016;74(2):295–302.
  11. Korde S, et al. MVP J Med Sci. 2018;5(2):125–133.
  12. Incyte Biosciences International Sarl. Data on File.
  13. Anbar T, et al. Exp Dermatol. 2014;23(4):219–223.

UNITED KINGDOM
Adverse events should be reported. Reporting forms and information can be found at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. Adverse events should also be reported to Incyte immediately by calling 03301003677 (Great Britain) 00-800-0002-7423 (United Kingdom (Northern Ireland)).

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.