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OPZELURA is indicated for the topical treatment of nonsegmental vitiligo in adult and pediatric patients 12 years of age and older.

Limitations of Use: Use of OPZELURA in combination with therapeutic biologics, other JAK inhibitors, or potent immunosuppressants such as azathioprine or cyclosporine is not recommended.

OPZELURA healthcare professionals vitiligo homepage

Nonsegmental Vitiligo

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FACIAL REPIGMENTATION RESULTS

PROVEN TO REPIGMENT
THE FACE1

24 & 52 WEEK DATA
2 YEAR DATA

FACIAL REPIGMENTATION OVER TIME

 

Nearly 1 in 3 patients achieved at least 75% improvement in the facial vitiligo area scoring index*(F-VASI75) at 24 weeks (primary endpoint; 29.9% for OPZELURA vs. 7.5% for vehicle (P < 0.0001) and 29.9% for OPZELURA vs. 12.9% for vehicle (P < 0.01))1-3†‡

F-VASI75 RESULTS THROUGH WEEK 52 (TRuE-V1 AND TRuE-V2 COMBINED)1,2

The line graph above shows the pooled F-VASI75 scores for OPZELURA and vehicle from the TRuE-V1 and TRuE-V2 clinical trials from Week 0 to Week 52. About half the patients remaining in the study who applied OPZELURA from Day 1 achieved F-VASI75 at 52 weeks: ≈51% for OPZELURA and ≈28% for vehicle-to-OPZELURA (Week 24 to Week 52).2

View study design
View f-vasi75 photos

After the initial 24-week double-blind period, patients in both trial arms could elect to apply OPZELURA twice daily for 28 weeks in the open-label extension. Extension data are as observed.1

Limitations of an open-label extension: In an open-label extension there is a potential for enrichment of the long-term data in the remaining patient populations since patients who are unable to tolerate or do not respond to the drug often drop out.

  • Extension data are as observed
  • No conclusions of safety or efficacy should be made based on these results

*The facial vitiligo area scoring index (F-VASI) is a composite measurement of the overall area of facial vitiligo patches and degree of depigmentation within patches.4 As assessed, the face did not include surface area of the lips, scalp, or ears.2

†P-values from exact logistic regression: [response at Week 24 = treatment + stratification factors (Fitzpatrick skin type I and II vs. Fitzpatrick skin type III, IV, V, and VI, Region North America/Europe)].2

‡In TRuE-V1 and TRuE-V2, respectively.

During the double-blind period (up to Week 24), multiple imputation was applied to account for missing values.5

During the open-label extension (after Week 24), responses were reported as observed.5

SEE F-VASI90 RESULTS

FACIAL REPIGMENTATION OVER TIME

 

Complete or nearly complete repigmentation in F-VASI (F-VASI90) was achieved by ≈15% of patients at 24 weeks (15.5% vs. 2.2% (P < 0.01) and 15.4% vs. 1.9% (P < 0.05))1,3

F-VASI90 RESULTS THROUGH WEEK 52 (TRuE-V1 AND TRuE-V2 COMBINED)2

The line graph above shows the pooled F-VASI90 scores for OPZELURA and vehicle from the TRuE-V1 and TRuE-V2 clinical trials from Week 0 to Week 52. At Week 52, ≈31% of patients for OPZELURA and ≈14% of patients for vehicle-to-OPZELURA (Week 24 to Week 52) achieved F-VASI90.2

View study design
View f-vasi90 photos

After the initial 24-week double-blind period, patients in both trial arms could elect to apply OPZELURA twice daily for 28 weeks in the open-label extension. Extension data are as observed.1

Limitations of an open-label extension: In an open-label extension there is a potential for enrichment of the long-term data in the remaining patient populations since patients who are unable to tolerate or do not respond to the drug often drop out.

  • Extension data are as observed
  • No conclusions of safety or efficacy should be made based on these results

F-VASI, facial vitiligo area scoring index.

During the double-blind period (up to Week 24), multiple imputation was applied to account for missing values.5

During the open-label extension (after Week 24), responses were reported as observed.5

F-VASI as assessed did not include surface area of the lips, scalp, or ears.2

SEE F-VASI50 RESULTS

FACIAL REPIGMENTATION OVER TIME

 

Over half of the OPZELURA group achieved F-VASI50 at 24 weeks (51.5% vs. 17.2% and 51.4% vs. 23.4%; P < 0.0001)3

F-VASI50 RESULTS THROUGH WEEK 52 (TRuE-V1 AND TRuE-V2 COMBINED)2

The line graph above shows the pooled F-VASI50 scores for OPZELURA and vehicle from the TRuE-V1 and TRuE-V2 clinical trials from Week 0 to Week 52. At Week 52, ≈75% of patients for OPZELURA and ≈53% of patients for vehicle-to-OPZELURA (Week 24 to Week 52) achieved F-VASI50.2

View study design
View f-vasi50 photos

After the initial 24-week double-blind period, patients in both trial arms could elect to apply OPZELURA twice daily for 28 weeks in the open-label extension. Extension data are as observed.1

Limitations of an open-label extension: In an open-label extension there is a potential for enrichment of the long-term data in the remaining patient populations since patients who are unable to tolerate or do not respond to the drug often drop out.

  • Extension data are as observed
  • No conclusions of safety or efficacy should be made based on these results

F-VASI, facial vitiligo area scoring index.

During the double-blind period (up to Week 24), multiple imputation was applied to account for missing values.5

During the open-label extension (after Week 24), responses were reported as observed.5

F-VASI as assessed did not include surface area of the lips, scalp, or ears.2

 

AMONG THOSE PATIENTS WHO DID NOT REACH F-VASI90 AT 52 WEEKS,

2-YEAR RESULTS WITH OPZELURA

F-VASI75 (WEEKS 52-104)

F-VASI75 (WEEKS 52-104)

MANY PATIENTS CONTINUED
TO SEE IMPROVEMENT IN
FACIAL REPIGMENTATION
THROUGH 2 YEARS6

 

The proportion of patients who achieved F-VASI75 increased with twice-daily OPZELURA treatment through 104 weeks6

The line graph above shows the pooled F-VASI75 scores for patients applying OPZELURA from Week 52 to Week 104 in the subset of patients who did not reach F-VASI90 at Week 52. Among patients who applied OPZELURA from Day 1, the proportion of patients who achieved F-VASI75 more than doubled from ≈31% at Week 52 to ≈66% at Week 104. Among patients who switched from vehicle to OPZELURA at Week 24, the proportion of patients who achieved F-VASI75 nearly tripled from ≈16% at Week 52 to ≈47% at Week 104.6

Open-label treatment-extension data were reported as observed. In an open-label extension there is a potential for enrichment of the long-term data in the remaining patient populations. No conclusions of efficacy or safety should be made based on the extension study results.

VISIBLE RESULTS

See facial and body repigmentation photos of OPZELURA clinical trial participants.

VIEW PATIENT PHOTOS
SETTING PATIENT EXPECTATIONS

View our checklist for setting 
patient expectations.

VIEW THE CHECKLIST

Important Safety Information and indication

 

INDICATION

OPZELURA is indicated for the topical treatment of nonsegmental vitiligo in adult and pediatric patients 12 years of age and older.

Limitations of Use: Use of OPZELURA in combination with therapeutic biologics, other JAK inhibitors, or potent immunosuppressants such as azathioprine or cyclosporine is not recommended.

IMPORTANT SAFETY INFORMATION

SERIOUS INFECTIONS
Patients treated with oral Janus kinase inhibitors for inflammatory conditions are at risk for developing serious infections that may lead to hospitalization or death. Reported infections include:
  • Active tuberculosis, which may present with pulmonary or extrapulmonary disease.
  • Invasive fungal infections, including cryptococcosis and pneumocystosis.
  • Bacterial, viral, including herpes zoster, and other infections due to opportunistic pathogens.
Avoid use of OPZELURA in patients with an active, serious infection, including localized infections. If a serious infection develops, interrupt OPZELURA until the infection is controlled. Carefully consider the benefits and risks of treatment prior to initiating OPZELURA in patients with chronic or recurrent infection. Closely monitor patients for the development of signs and symptoms of infection during and after treatment with OPZELURA.

Serious lower respiratory tract infections were reported in the clinical development program with topical ruxolitinib.

No cases of active tuberculosis (TB) were reported in clinical trials with OPZELURA. Cases of active TB were reported in clinical trials of oral Janus kinase inhibitors used to treat inflammatory conditions. Consider evaluating patients for latent and active TB infection prior to administration of OPZELURA. During OPZELURA use, monitor patients for the development of signs and symptoms of TB.

Viral reactivation, including cases of herpes virus reactivation (e.g., herpes zoster), were reported in clinical trials with Janus kinase inhibitors used to treat inflammatory conditions including OPZELURA. If a patient develops herpes zoster, consider interrupting OPZELURA treatment until the episode resolves.

Hepatitis B viral load (HBV-DNA titer) increases, with or without associated elevations in alanine aminotransferase and aspartate aminotransferase, have been reported in patients with chronic HBV infections taking oral ruxolitinib. OPZELURA initiation is not recommended in patients with active hepatitis B or hepatitis C.

MORTALITY

In a large, randomized, postmarketing safety study in rheumatoid arthritis (RA) patients 50 years of age and older with at least one cardiovascular risk factor comparing an oral JAK inhibitor to tumor necrosis factor (TNF) blocker treatment, a higher rate of all-cause mortality, including sudden cardiovascular death, was observed with the JAK inhibitor. Consider the benefits and risks for the individual patient prior to initiating or continuing therapy with OPZELURA.

MALIGNANCIES

Malignancies were reported in patients treated with OPZELURA. Lymphoma and other malignancies have been observed in patients receiving JAK inhibitors used to treat inflammatory conditions. In RA patients treated with an oral JAK inhibitor, a higher rate of malignancies (excluding non-melanoma skin cancer (NMSC)) was observed when compared with TNF blockers. Patients who are current or past smokers are at additional increased risk.

Consider the benefits and risks for the individual patient prior to initiating or continuing therapy with OPZELURA, particularly in patients with a known malignancy (other than successfully treated non-melanoma skin cancers), patients who develop a malignancy when on treatment, and patients who are current or past smokers.

Non-melanoma skin cancers, including basal cell and squamous cell carcinoma, have occurred in patients treated with OPZELURA. Perform periodic skin examinations during OPZELURA treatment and following treatment as appropriate. Exposure to sunlight and UV light should be limited by wearing protective clothing and using broad-spectrum sunscreen.

MAJOR ADVERSE CARDIOVASCULAR EVENTS (MACE)

In RA patients 50 years of age and older with at least one cardiovascular risk factor treated with an oral JAK inhibitor, a higher rate of major adverse cardiovascular events (MACE) (defined as cardiovascular death, myocardial infarction, and stroke), was observed when compared with TNF blockers. Patients who are current or past smokers are at additional increased risk. Discontinue OPZELURA in patients who have experienced a myocardial infarction or stroke.

Consider the benefits and risks for the individual patient prior to initiating or continuing therapy with OPZELURA, particularly in patients who are current or past smokers and patients with other cardiovascular risk factors. Patients should be informed about the symptoms of serious cardiovascular events and the steps to take if they occur. Discontinue OPZELURA in patients that have experienced a myocardial infarction or stroke.

THROMBOSIS
Thromboembolic events were observed in trials with OPZELURA. Thrombosis, including pulmonary embolism (PE), deep venous thrombosis (DVT), and arterial thrombosis have been reported in patients receiving JAK inhibitors used to treat inflammatory conditions. Many of these adverse reactions were serious and some resulted in death. In RA patients 50 years of age and older with at least one cardiovascular risk factor treated with an oral JAK inhibitor, a higher rate of thrombosis was observed when compared with TNF blockers. Avoid OPZELURA in patients at risk. If symptoms of thrombosis occur, discontinue OPZELURA and treat appropriately.
Thrombocytopenia, Anemia, and Neutropenia

Thrombocytopenia, anemia, and neutropenia were reported in the clinical trials with OPZELURA. Consider the benefits and risks for individual patients who have a known history of these events prior to initiating therapy with OPZELURA. Perform CBC monitoring as clinically indicated. If signs and/or symptoms of clinically significant thrombocytopenia, anemia, and neutropenia occur, patients should discontinue OPZELURA.

Lipid Elevations

Treatment with oral ruxolitinib has been associated with increases in lipid parameters including total cholesterol, low-density lipoprotein (LDL) cholesterol, and triglycerides.

Adverse Reactions

In nonsegmental vitiligo, the most common adverse reactions (incidence ≥1%) are application site acne (6%), application site pruritus (5%), nasopharyngitis (4%), headache (4%), urinary tract infection (2%), application site erythema (2%), and pyrexia (1%).

Pregnancy

There is a pregnancy registry that monitors pregnancy outcomes in pregnant persons exposed to OPZELURA during pregnancy. Pregnant persons exposed to OPZELURA and healthcare providers should report OPZELURA exposure by calling 1-855-463-3463.

Lactation

Advise women not to breastfeed during treatment with OPZELURA and for approximately four weeks after the last dose (approximately 5-6 elimination half-lives).

Please see Full Prescribing Information, including Boxed Warning, and Medication Guide for OPZELURA.
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Indication

OPZELURA is indicated for the topical treatment of nonsegmental vitiligo in adult and pediatric patients

Important Safety Information

Important Safety Information and indication

Serious Infections

Patients treated with oral Janus kinase inhibitors for inflammatory conditions are at risk for developing serious infections that may lead to hospitalization or death. Reported infections include:

Patients treated with oral Janus kinase inhibitors for inflammatory conditions are at risk for developing serious infections that may lead to hospitalization or death. Reported infections include:

References: 1. OPZELURA [Prescribing information]. Wilmington, DE: Incyte Corporation. 2. Data on File. Incyte Corporation. 3. Rosmarin D, Pandya AG, Grimes P, et al. Efficacy and safety of ruxolitinib cream for the treatment of vitiligo: 24-week results from 2 randomized, double-blind phase 3 studies. Presented at the 30th European Academy of Dermatology and Venereology (EADV) Congress; September 29−October 2, 2021; Virtual. 4. Rosmarin D, Pandya AG, Lebwohl M, et al. Ruxolitinib cream for treatment of vitiligo: a randomised, controlled, phase 2 trial. Lancet. 2020;396(suppl):110-120. doi:10.1016/S0140-6736(20)30609-7 5. Rosmarin D, Passeron T, Pandya AG, et al. Efficacy and safety of ruxolitinib cream monotherapy for the treatment of vitiligo: results from two 52 week phase 3 studies. Presented at the American Academy of Dermatology Annual Meeting; March 25–29, 2022; Boston, MA. 6. Rosmarin D, Sebastian M, Amster M, et al. Facial and total vitiligo area scoring index response shift during 104 weeks of ruxolitinib cream treatment for vitiligo: results from the open-label arm of the TRuE-V long-term extension phase 3 study. Presented at the American Academy of Dermatology Annual Meeting; March 17–21, 2023; New Orleans, LA.