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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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PRESTON:
REAL OPZELURA PATIENT

Preston, real opzelura patient Preston, real opzelura patient
24- & 52-WEEK DATA
104-WEEK DAТА

IN TRuE-V1 AND TRuE-V2

Consistent use, continual results1-5

75% FACIAL REPIGMENTATION (F-VASI75) AT 24 AND 52 WEEKS

THE EARLIEST PRIMARY ENDPOINT IN NSV1

F-vasi75 results at 24 weeks

Primary endpoint measured F-VASI75 at Week 24 across two studies (TRuE-V1 and TRuE-V2): 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), respectively.1-3*†

View patient photos

75% FACIAL REPIGMENTATION THROUGH 52 WEEKS1,3

Line graph of facial repigmentation over 52 weeks
Line graph of facial repigmentation over 52 weeks

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

In the vehicle-to-OPZELURA group, 28% of patients reached F-VASI75 at 52 weeks.1,3

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 F-VASI75 scores for OPZELURA from the TRuE-V1 and TRuE-V2 clinical trials from Week 0 to Week 52. About a third of the patients who applied OPZELURA achieved F-VASI75 at 24 weeks: ≈30% for OPZELURA and ≈10% for vehicle (Week 0 to Week 24). 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).3

View study design

*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)].3

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

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. As assessed, the face did not include surface area of the lips, scalp, or ears.6

During the double-blind period (up to Week 24), multiple imputation was applied to account for missing values.7

During the open-label extension (after Week 24), responses were reported as observed.7

SEE F-VASI90 RESULTS

IN TRuE-V1 AND TRuE-V2

Consistent use, continual results1-5

90% FACIAL REPIGMENTATION (F-VASI90) AT 24 AND 52 WEEKS

SECONDARY ENDPOINTS

F-vasi90 results at 24 weeks
F-vasi90 results at 52 weeks

Key secondary endpoint measured 
F-VASI90 across two studies (TRuE-V1 and TRuE-V2): 15.5% for OPZELURA vs. 
2.2% for vehicle (P < 0.01) and 15.4% for OPZELURA vs. 1.9% for vehicle (P < 0.05) at Week 24.1-3

View patient photos

90% FACIAL REPIGMENTATION THROUGH 52 WEEKS1,3

Graph of 90% facial repigmentation over 52 weeks
Graph of 90% facial repigmentation over 52 weeks

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: 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 F-VASI90 scores for OPZELURA and vehicle from the TRuE-V1 and TRuE-V2 clinical trials from Week 0 to Week 52. About a sixth of the patients who applied OPZELURA achieved F-VASI90 at 24 weeks: ≈16% for OPZELURA and ≈2% for vehicle (Week 0 to Week 24). At Week 52, ≈31% of patients for OPZELURA and ≈14% of patients for vehicle-to-OPZELURA (Week 24 to Week 52) achieved F-VASI90.3

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.7

During the open-label extension (after Week 24), responses were reported as observed.7

F-VASI as assessed did not include surface area of the lips, scalp, or ears.6

See F-VASI50 Results

IN TRuE-V1 AND TRuE-V2

Consistent use, continual results1-5

50% FACIAL REPIGMENTATION (F-VASI50) AT 24 AND 52 WEEKS

SECONDARY ENDPOINTS

F-vasi50 results at 24 weeks
F-vasi50 results at 52 weeks

Key secondary endpoint measured 
F-VASI50 across two studies (TRuE-V1 and TRuE-V2): 51.5% for OPZELURA vs. 17.2% for vehicle and 51.4% for OPZELURA vs. 23.4% for vehicle (P < 0.0001) at 
Week 24.2,3

View patient photos

50% FACIAL REPIGMENTATION THROUGH 52 WEEKS2,3

Graph of 50% facial repigmentation over 52 weeks
Graph of 50% facial repigmentation over 52 weeks

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: 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 F-VASI50 scores for OPZELURA and vehicle from the TRuE-V1 and TRuE-V2 clinical trials from Week 0 to Week 52. About half of the patients who applied OPZELURA achieved F-VASI50 at 24 weeks: ≈52% for OPZELURA and ≈19% for vehicle (Week 0 to Week 24). At Week 52, ≈75% of patients for OPZELURA and ≈53% of patients for vehicle-to-OPZELURA (Week 24 to Week 52) achieved F-VASI50.3

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.7

During the open-label extension (after Week 24), responses were reported as observed.7

F-VASI as assessed did not include surface area of the lips, scalp, or ears.6

A 104-WEEK POST-HOC
ANALYSIS MEASURING
ONGOING IMPROVEMENT 5

 

In a post-hoc exploratory analysis, a subset of patients from TRuE-V1, 
TRuE-V2, and TRuE-V LTE on OPZELURA from Day 1 were assessed through 104 weeks. Patients randomized to vehicle 
in TRuE-V1, TRuE-V2, or TRuE-V LTE 
were excluded.5

F-VASI75 RESPONSE THROUGH 104 WEEKS5

F-vasi75 response rates over 104 weeks

F-VASI75 RESPONSE THROUGH 104 WEEKS5

F-vasi75 response rates over 104 weeks

Adapted from Estebaranz et al. EADV Congress. 2024.

Data were reported as observed. No conclusions of safety or efficacy should be made based on these results.

The line graph above shows the percentage of patients achieving F-VASI75 over time with continuous OPZELURA treatment through 2 years in a post-hoc analysis. Among this subset of patients, ≈43% achieved F-VASI75 at Week 52 and ≈71% at Week 104. Patients initially randomized to vehicle were excluded.5

TIFFANIE’S JOURNEY

Results may vary.

Tiffanie was compensated for her participation.

TIFFANIE’S
REPIGMENTATION JOURNEY

Tiffanie was diagnosed with nonsegmental vitiligo at age 7. Despite years of working towards self-acceptance, the decision to pursue repigmentation was not easy. Hear how she drew on resilience instilled by her grandmother, gained confidence to start treatment with OPZELURA, and founded the I AM GREAT MOVEMENT.

TIFFANIE’S JOURNEY

Results may vary.

Tiffanie was compensated for her participation.

BEFORE & AFTERS

See facial and body repigmentation photos from OPZELURA clinical trials and real-world patients.

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 (JAK) inhibitors for inflammatory conditions are at risk for serious infections that may lead to hospitalization or death. These include:
  • Active tuberculosis, which may present with pulmonary or extrapulmonary disease.
  • Invasive fungal infections, including cryptococcosis and pneumocystosis.
  • Other bacterial or viral infections, including herpes zoster, due to opportunistic pathogens.
Avoid use in patients with an active, serious infection. If a serious infection develops, stop OPZELURA until the infection is controlled. Carefully consider the benefits and risks of treatment prior to use in patients with chronic or recurrent infection. Closely monitor patients for the development of signs 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; however, cases were reported in clinical trials of oral JAK inhibitors to treat inflammatory conditions. Consider evaluating patients for latent and active TB infection prior to treatment. Monitor patients for the development of signs and symptoms of TB.

Viral reactivation, including cases of herpes virus reactivation, were reported in clinical trials with JAK 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 is not recommended in patients with active hepatitis B or hepatitis C.

POST-MARKETING SAFETY

In a large randomized postmarketing safety study of rheumatoid arthritis (RA) patients 50 years and older with at least one cardiovascular risk factor, the following were higher with an oral JAK inhibitor than with a tumor necrosis factor (TNF) blocker:

all-cause mortality, major adverse cardiovascular events (defined as cardiovascular death, myocardial infarction, and stroke), thrombosis, malignancies (excluding non-melanoma skin cancer [NMSC]).

Consider the benefits and risks prior to initiating or continuing therapy with OPZELURA. Discontinue OPZELURA in patients who have experienced a myocardial infarction or stroke.

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. Patients who are current or past smokers are at increased risk. Inform patients about the symptoms of serious cardiovascular events and the steps to take if they occur.

Consider the benefits and risks prior to initiating therapy with OPZELURA, particularly in patients:

  • with a known malignancy (other than successfully treated non-melanoma skin cancers),
  • who develop a malignancy when on treatment,
  • with cardiovascular risk factors and
  • 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. Limit exposure to sunlight and UV light with protective clothing and broad-spectrum sunscreen.

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. Avoid OPZELURA in patients at risk. If symptoms of thrombosis occur, discontinue OPZELURA and treat appropriately.
CYTOPENIAS

Thrombocytopenia, anemia, neutropenia, lymphopenia, and leukopenia were reported in the clinical trials with OPZELURA. Consider the benefits and risks for patients who have a known history of these events prior to initiating therapy. Perform CBC monitoring as clinically indicated. Discontinue OPZELURA if symptoms associated with clinically significant decreases in laboratory values occur.

POTENTIAL RISKS RELATED TO JAK INHIBITION

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

ADVERSE REACTIONS

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

PREGNANCY REGISTRY

There is a registry that monitors pregnancy outcomes in 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.
See More  

Indication

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

Important Safety Information

Important Safety Information and indication

Serious Infections

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

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

References: 1. OPZELURA Prescribing Information. Wilmington, DE: 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. Data on File. Incyte Corporation. 4. Harris JE, Papp K, Forman SB, et al. Relapse and maintenance of clinical response in the randomized withdrawal arm of the TRuE-V long-term extension phase 3 study of ruxolitinib cream in vitiligo. Presented at the American Academy of Dermatology Annual Meeting; March 17–21, 2023; New Orleans, LA. 5. Estebaranz JL, Harris JE, Ezzedine K, et al. Efficacy and safety of ruxolitinib cream for the treatment of vitiligo through 2 years in the TRuE-V studies. Presented at the European Academy of Dermatology and Venereology (EADV) Congress; September 25–28, 2024; Amsterdam, Netherlands. 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 7. 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.