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OPZELURA is indicated for the topical short-term and non-continuous chronic treatment of mild to moderate atopic dermatitis in non-immunocompromised adult and pediatric patients 12 years of age and older whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable.

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.

PATIENT PHOTOS

SEE HOW OPZELURA MAY BE ABLE TO HELP YOUR PATIENTS

CONSIDER OPZELURA FOR ALL YOUR APPROPRIATE PATIENTS WITH ITCHY, MILD TO MODERATE AD1

A patient for whom OPZELURA may be appropriate1:

  • Has itchy, mild to moderate atopic dermatitis
  • Is 12 years of age or older
  • Has an affected BSA of up to 20%
  • Has tried topical corticosteroid (TCS) and/or topical calcineurin inhibitor (TCI), unless the use of such alternatives is not advisable
  • Will not be using OPZELURA in combination with:
  • Therapeutic biologics
  • Other JAK inhibitors
  • Potent immunosuppressants

In particular, OPZELURA may be an appropriate choice for patients for whom other topicals haven’t worked, but who do not want to move onto an injectable or systemic treatment.1

Routine bloodwork when using OPZELURA is not required. However, blood tests may be called for to evaluate potential side effects or for patients with a history of hematologic malignancies.1

BSA, body surface area; JAK, Janus kinase.

 

CLINICAL TRIAL PHOTOS

SEE THE OPZELURA DIFFERENCE

PATIENT 1 - KNEE2

BASELINE 
(IGA* = 3, NRS = 3.57, BSA = 3%)

A photo of a patient's knee showing atopic dermatitis before treatment with OPZELURA that has an IGA of 3
A close-up photo of a patient's knee showing atopic dermatitis before treatment with OPZELURA that has an IGA of 3

WEEK 2 
(IGA = 1, NRS = 0.43, BSA = 2%)

A photo of a patient's knee showing atopic dermatitis after 2 weeks of treatment with OPZELURA and a resulting IGA score of 1
A close-up photo of a patient's knee showing atopic dermatitis after 2 weeks of treatment with OPZELURA and a resulting IGA score of 1

WEEK 8 
(IGA = 0, NRS = 0, BSA = 0%)

A photo of a patient's knee showing atopic dermatitis after 8 weeks of treatment with OPZELURA and a resulting IGA score of 0
A close-up photo of a patient's knee showing atopic dermatitis after 8 weeks of treatment with OPZELURA and a resulting IGA score of 0

Actual clinical trial participant. Individual results may vary.

PATIENT 2 - NECK2

BASELINE
(IGA* = 3, NRS = 8.57, BSA = 5.5%)

A photo of a patient's neck showing atopic dermatitis before treatment with OPZELURA that has an IGA of 3
A close-up photo of a patient's neck showing atopic dermatitis before treatment with OPZELURA that has an IGA of 3

WEEK 2 
(IGA = 2, NRS = 1.75, BSA = 4.5%)

A photo of a patient's neck showing atopic dermatitis after 2 weeks of treatment with OPZELURA and a resulting IGA score of 2
A close-up photo of a patient's neck showing atopic dermatitis after 2 weeks of treatment with OPZELURA and a resulting IGA score of 2

WEEK 8 
(IGA = 1, NRS = N/A, BSA = 0.1%)

A photo of a patient's neck showing atopic dermatitis after 8 weeks of treatment with OPZELURA and a resulting IGA score of 1
A close-up photo of a patient's neck showing atopic dermatitis after 8 weeks of treatment with OPZELURA and a resulting IGA score of 1

Actual clinical trial participant. Individual results may vary.

PATIENT 3 - BACK OF KNEE2

BASELINE
(IGA* = 3, NRS = 3.86, BSA = 7%)

A photo of the back of a patient's knee showing atopic dermatitis before treatment with OPZELURA that has an IGA of 3
A close-up photo of the back of a patient's knee showing atopic dermatitis before treatment with OPZELURA that has an IGA of 3

WEEK 2 
(IGA = 2, NRS = 0, BSA = 3%)

A photo of the back of a patient's knee showing atopic dermatitis after 2 weeks of treatment with OPZELURA and a resulting IGA score of 2
A close-up photo of the back of a patient's knee showing atopic dermatitis after 2 weeks of treatment with OPZELURA and a resulting IGA score of 2

WEEK 8 
(IGA = 1, NRS = 0, BSA = 1%)

A photo of the back of a patient's knee showing atopic dermatitis after 8 weeks of treatment with OPZELURA and a resulting IGA score of 1
A close-up photo of the back of a patient's knee showing atopic dermatitis after 8 weeks of treatment with OPZELURA and a resulting IGA score of 1

Actual clinical trial participant. Individual results may vary.

PATIENT 4 - CALF2

BASELINE
(IGA* = 3, NRS = 5.86, BSA = 3.5%)

A photo of a patient's calf showing atopic dermatitis before treatment with OPZELURA that has an IGA of 3
A close-up photo of a patient's calf showing atopic dermatitis before treatment with OPZELURA that has an IGA of 3

WEEK 2 
(IGA = 2, NRS = 1.57, BSA = 1.75%)

A photo of a patient's calf showing atopic dermatitis after 2 weeks of treatment with OPZELURA and a resulting IGA score of 4
A close-up photo of a patient's calf showing atopic dermatitis after 2 weeks of treatment with OPZELURA and a resulting IGA score of 4

WEEK 8 
(IGA = 0, NRS = 0, BSA = 0%)

A photo of a patient's calf showing atopic dermatitis after 8 weeks of treatment with OPZELURA and a resulting IGA score of 0
A close-up photo of a patient's calf showing atopic dermatitis after 8 weeks of treatment with OPZELURA and a resulting IGA score of 0

Actual clinical trial participant. Individual results may vary.

PATIENT 5 - BACK2

BASELINE 
(IGA* = 3, NRS = 7.57, BSA = 17%)

A photo of a patient's back showing atopic dermatitis before treatment with OPZELURA that has an IGA of 3
A close-up photo of a patient's back showing atopic dermatitis before treatment with OPZELURA that has an IGA of 3

WEEK 2 
(IGA = 1, NRS = 3, BSA = 4.5%)

A photo of a patient's back showing atopic dermatitis after 2 weeks of treatment with OPZELURA and a resulting IGA score of 1
A close-up photo of a patient's back showing atopic dermatitis after 2 weeks of treatment with OPZELURA and a resulting IGA score of 1

WEEK 8 
(IGA = 1, NRS = 0, BSA = 0.1%)

A photo of a patient's back showing atopic dermatitis after 8 weeks of treatment with OPZELURA and a resulting IGA score of 1
A close-up photo of a patient's back showing atopic dermatitis after 8 weeks of treatment with OPZELURA and a resulting IGA score of 1

Actual clinical trial participant. Individual results may vary.

PATIENT 6 - NECK2

BASELINE 
(IGA* = 3, NRS = 2.43, BSA = 8.2%)

A photo of a patient's neck showing atopic dermatitis before treatment with OPZELURA that has an IGA of 3
A close-up photo of a patient's neck showing atopic dermatitis before treatment with OPZELURA that has an IGA of 3

WEEK 2 
(IGA = 2, NRS = 1.43, BSA = 5.6%)

A photo of a patient's neck showing atopic dermatitis after 2 weeks of treatment with OPZELURA and a resulting IGA score of 2
A close-up photo of a patient's neck showing atopic dermatitis after 2 weeks of treatment with OPZELURA and a resulting IGA score of 2

WEEK 8 
(IGA = 1, NRS = 2.43, BSA = 2.3%)

A photo of a patient's neck showing atopic dermatitis after 8 weeks of treatment with OPZELURA and a resulting IGA score of 1
A close-up photo of a patient's neck showing atopic dermatitis after 8 weeks of treatment with OPZELURA and a resulting IGA score of 1

Actual clinical trial participant. Individual results may vary.

*Measured by IGA-TS, defined as the achievement of clear (IGA 0) or almost clear (IGA 1) skin with at least a 2-point improvement from baseline; IGA is assessed on a severity scale of 0 to 4.1

Itch NRS4 is defined as the achievement of at least a 4-point improvement in daily itch on a 0- to 10-point scale, considered a clinically meaningful response.

Patients in the analysis had an NRS score ≥4 at baseline; mean NRS score at baseline was 5.1,3

BSA, body surface area; IGA, Investigator's Global Assessment; IGA-TS, Investigator's Global Assessment treatment success; NRS, numerical rating scale.

Visualizing real-world results with Opzelura2

The following images depict actual patients treated with OPZELURA. Not clinical trial participants. Scoring was designated by the treating physician. Because the following patients are real-world patients, there may be other factors influencing their treatment results, and individual results may vary.

Actual patient treated with OPZELURA. Not a clinical trial participant.        
Scoring was designated by the treating physician. Because this is a real-world patient, there may be other factors influencing treatment results, and individual results may vary. No conclusions of safety or efficacy should be made based on these results.

Photos by Dr. Jason Smith, MD (Dermatologist - Rome, GA).

BSA, body surface area; IGA, Investigator's Global Assessment.

“TALK SOONER"

An online quantitative survey* was conducted on behalf of Incyte from March 19 to May 10, 2024 including 95 current OPZELURA users with AD.2

According to the 95 AD patients,

96% OF PATIENTS WISHED THEY KNEW ABOUT OPZELURA SOONER2

Data were self-reported and outcomes may vary. No conclusions of safety or efficacy should be made based on these results.

Limitations: This survey relied on self-reported data, was not confirmed by a medical professional, and can be affected by bias from selection, recall, response styles, and other sources. Opinions may not be representative of the general population.

 

*Participants with AD reported they: had received an AD diagnosis; had been using OPZELURA for ≥2 weeks; were current or former users of topical corticosteroids and/or non-steroidal creams.2

The survey covered condition and treatment background, AD disease state, OPZELURA experience, and overall OPZELURA satisfaction.2

AD, atopic dermatitis.

Important Safety Information and indication

 

INDICATION

OPZELURA is indicated for the topical short-term and non-continuous chronic treatment of mild to moderate atopic dermatitis in non-immunocompromised adult and pediatric patients 12 years of age and older whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable.

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 atopic dermatitis, the most common adverse reactions (≥1%) are nasopharyngitis (3%), diarrhea (1%), bronchitis (1%), ear infection (1%), eosinophil count increased (1%), urticaria (1%), folliculitis (1%), tonsillitis (1%), and rhinorrhea (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.

Indication

OPZELURA is indicated for the topical short-term and non-continuous chronic treatment of mild to moderate atopic

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. Papp K, Szepietowski JC, Kircik L, et al. Efficacy and safety of ruxolitinib cream for the treatment of atopic dermatitis: results from 2 phase 3, randomized, double-blind studies. J Am Acad Dermatol. 2021;85(4):863-872. doi:10.1016/j.jaad.2021.04.085