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STUDY DESIGN

EVALUATED IN 2 RANDOMIZED, VEHICLE-CONTROLLED PHASE III STUDIES IN NONSEGMENTAL VITILIGO1,2

STUDY DESIGN1,3

OPZELURA monotherapy was evaluated in 2 randomized, vehicle-controlled phase III studies in vitiligo
OPZELURA monotherapy was evaluated in 2 randomized, vehicle-controlled phase III studies in vitiligo

BSA, body surface area.

OPZELURA was studied in 2 double-blind, randomized, vehicle-controlled trials of identical design that enrolled 674 adult and adolescent patients with nonsegmental vitiligo ≥12 years of age. Patients had depigmented areas affecting ≥0.5% facial body surface area (F-BSA), ≥3% nonfacial BSA, and total body vitiligo area (facial and nonfacial) of up to 10% BSA. Patients with complete leukotrichia within any facial lesion were excluded. Phototherapy was not permitted during the trials. In both trials, patients were randomized 2:1 to treatment with OPZELURA or vehicle cream twice daily (BID) for 24 weeks followed by a 28-week open-label extension, wherein patients originally assigned to vehicle could switch to OPZELURA.1,3

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.

OPZELURA was studied as monotherapy.1,2

WHAT IS THE VITILIGO AREA SCORING INDEX?

The vitiligo area scoring index (VASI) is a composite measurement of overall area of vitiligo patches and degree of depigmentation within patches.4

Primary Endpoint
  • F-VASI75: the proportion of participants achieving a 75% improvement in the facial vitiligo area scoring index (F-VASI75) at Week 241
Key Secondary Endpoints
  • F-VASI90: the proportion of participants achieving a 90% improvement in F-VASI at Week 241
  • F-VASI50: the proportion of participants achieving a 50% improvement in F-VASI at Week 245
  • T-VASI50: the proportion of participants achieving a 50% improvement in T-VASI at Week 245
Selected Secondary Endpoints
  • F-VASI75 at Week 52: the proportion of participants achieving a 75% improvement in F-VASI at Week 525
  • F-VASI90 at Week 52: the proportion of participants achieving a 90% improvement in F-VASI at Week 525
  • T-VASI75 at Week 52: the proportion of participants achieving a 75% improvement in T-VASI at Week 525
  • F-VASI50 at Week 52: the proportion of participants achieving a 50% improvement in F-VASI at Week 525
  • F-VASI25 at Week 24: the proportion of participants achieving a 25% improvement in F-VASI at Week 245
  • Mean % change in F-VASI at Week 245

F-VASI: Facial vitiligo area scoring index.1

T-VASI: Total body vitiligo area scoring index.1

OPZELURA WAS STUDIED IN A RANGE OF PATIENTS1,3,5

OPZELURA clinical trials enrolled men and women with a wide age range (12-79), varying durations of disease, multiple ethnicities, all Fitzpatrick skin types, and those who had tried previous vitiligo therapies.1,3,5

OPZELURA was studied in a range of patients
OPZELURA was studied in a range of patients
BASELINE DEMOGRAPHICS1,3,5

Mean age 39.6 years3

Range 12-79 years5

 

Female 53%1

Male 47%1

DISEASE STATUS*

Stable 74%3

Progressive 26%3

*Determination was based on investigator judgment

82% of subjects were White, 5% were Black, and 4% were Asian1

Included all Fitzpatrick skin types (89% were types II-IV)1

Type I 2%1

Type II 30%1

Type III 40%1

Type IV 19%1

Type V 7%1

Type VI 2%1

 

Mean affected F-BSA 1%1

Mean affected T-BSA 7.4%1

 

Mean time since diagnosis 14.8 years1

Range 0-60.5 yrs3

36.4% diagnosed in childhood3

Prior therapy for vitiligo 61%3

Image of OPZELURA cream
Image of OPZELURA cream
SEE REPIGMENTATION RESULTS

OPZELURA has been shown to help
repigmentation over time.1

SEE THE DATA
SEE TOPICAL DOSING INFO FOR
OPZELURA CREAM

Review how and where to apply OPZELURA.

VIEW DOSING INFO

IMPORTANT SAFETY INFORMATION AND INDICATION

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.

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.

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.

References: 1. OPZELURA [Prescribing information]. Wilmington, DE: Incyte Corporation; 2022. 2. 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. 3. Rosmarin D, Ezzedine K, Desai SR, et al. Efficacy and safety of ruxolitinib cream for the treatment of vitiligo: week 24 pooled analysis of the TRuE-V phase 3 studies. Presented at the American Academy of Dermatology Annual Meeting; March 25–29, 2022; Boston, MA. 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. Data on File. Incyte Corporation. 2022.