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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.

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Nonsegmental Vitiligo

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BODY REPIGMENTATION RESULTS

SHOWN TO REPIGMENT THE BODY1

A person showing symptoms of nonsegmental vitiligo A person showing symptoms of nonsegmental vitiligo
24- & 52-WEEK DATA
2-YEAR DATA

50% BODY REPIGMENTATION OVER TIME

50% BODY REPIGMENTATION

Approximately 1 in 4 patients at 24 weeks
Approximately 1 in 2 patients at 52 weeks

T-VASI50 at 24 weeks was achieved by 20.6% and 26.1% for OPZELURA (vs. 4.9% and 11.3% with vehicle; P < 0.01) in TRuE-V1 and TRuE-V2, respectively2*

VIEW T-VASI50 PHOTOS

T-VASI50 RESULTS THROUGH WEEK 52 (TRuE-V1 AND TRuE-V2 COMBINED)1

T-VASI50 52-week data
T-VASI50 52-week data

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.3

Limitations of an open-label extension: 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 since patients who are unable to tolerate or do not respond to the drug often drop out. No conclusions of efficacy or safety should be made based on the extension study results.

The line graph above shows the pooled T-VASI50 scores for OPZELURA and vehicle from the TRuE-V1 and TRuE-V2 clinical trials from Week 0 to Week 52. About a quarter of the patients who applied OPZELURA achieved T-VASI50 at 24 weeks: ≈24% for OPZELURA and ≈7% for vehicle (Week 0 to Week 24). At Week 52, ≈51% of patients for OPZELURA and ≈27% of patients for vehicle-to-OPZELURA (Week 24 to Week 52) achieved T-VASI50.1

View study design

T-VASI, total body vitiligo area scoring index.

*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)].1

During the double-blind period (up to Week 24), multiple imputation was applied to account for missing values.4

During the open-label extension (after Week 24), responses were reported as observed.4

 

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

BODY REPIGMENTATION RESULTS AT 2 YEARS5

MANY PATIENTS CONTINUED 
TO SEE IMPROVEMENT IN 
BODY REPIGMENTATION 
THROUGH 2 YEARS5

 

The proportion of patients who achieved T-VASI50 increased with twice-daily OPZELURA treatment through 104 weeks5

†Mean affected T-BSA 7.47%.

T-VASI50 (WEEKS 52 TO 104)5

T-VASI50 104-week data

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.

The line graph above shows T-VASI50 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 T-VASI50 increased from ≈42% at Week 52 to ≈64% at Week 104. Among patients who switched from vehicle to OPZELURA at Week 24, the proportion of patients who achieved T-VASI50 increased from ≈17% at Week 52 to ≈55% at Week 104.5

Repigmentation across the body

Total body vitiligo area scoring index (T-VASI) measures the extent of depigmentation across the body. This scale can help for dosing measurements.6

view patient photos

T-VASI is broken down into the following 6 areas6:

1. Head and neck 2. Upper extremities 3. Trunk 4. Hands 5. Lower extremities 6. Feet
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: progress takes time!

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 Registry

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 or visiting www.opzelura.pregnancy.incyte.com.

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. Data on File. Incyte Corporation. 2. 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. 3. OPZELURA Prescribing Information. Wilmington, DE: Incyte Corporation. 4. 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. 5. 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. 6. 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