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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 2 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.

OPZELURA healthcare professionals atopic dermatitis homepage

Mild to Moderate Atopic Dermatitis

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skin clearance results: AGES 2-11

A CLEAR DIFFERENCE FOR PATIENTS AS YOUNG AS 2 YEARS1-3

IGA-TS
Skin Clearance at Week 52
Affected BSA at Week 52

PRIMARY ENDPOINT

CLEAR OR ALMOST CLEAR RESULTS (IGA-TS*) AT WEEK 83,4

 

MORE THAN 50% OF PATIENTS ACHIEVED CLEAR OR ALMOST CLEAR SKIN WITH ≥2-POINT IMPROVEMENT (IGA-TS) FROM BASELINE AT WEEK 81-3

VIEW TRIAL OVERVIEW

Adapted from Kallender. Mendeley Data. 2025.

*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

BID, twice daily; IGA, Investigator’s Global Assessment; IGA-TS, Investigator’s Global Assessment treatment success.

IGA-TS AT WEEK 8: CHART DESCRIPTION

The line graph above shows the proportion of IGA-TS responders for OPZELURA and vehicle from the TRuE-AD3 clinical trial from Week 0 to Week 8. At Week 8, 56.5% of patients taking OPZELURA achieved clear or almost clear results vs. 10.8% for vehicle. This demonstrates over 5x as many responders to OPZELURA than vehicle.3,4

 

LONG-TERM EXTENSION DATA

CLEAR OR ALMOST CLEAR SKIN THROUGH 52 WEEKS WITH AS-NEEDED USE OF MONOTHERAPY2

IGA* SCORES OF 0/1 THROUGH WEEK 52 (EXTENSION DATA)2

Adapted from Eichenfield et al. EADV Congress. 2024.

*IGA is assessed on a severity scale of 0 to 4.1

†Week 12-52 data excludes 1 patient in the OPZELURA group who completed the study but did not receive treatment in the LTS period (maintained IGA and BSA of 0).2

‡Vehicle group rerandomized to ruxolitinib 0.75% or OPZELURA at Week 8.2

 
  • Data were reported as observed2
  • No conclusions of safety or efficacy should be made based on these results
  • OPZELURA is for short-term and non-continuous use only1

VIEW TRIAL OVERVIEW

IGA SCORES OF 0/1 THROUGH WEEK 52: CHART DESCRIPTION

The line graph above shows the proportion of patients achieving IGA scores of 0/1 with OPZELURA at Week 52. In TRuE-AD3, 72.3% of patients on OPZELURA vs. 72.2% of patients on vehicle achieved clear or almost clear skin after switching from vehicle to OPZELURA and using as needed in the 44-week extension period.2

BID, twice daily; IGA, Investigator's Global Assessment.

BID, twice daily; IGA, Investigator's Global Assessment.

AMONG THOSE ON OPZELURA SINCE DAY 1

Patients ages 2 to 11 spent a median of 5 months off treatment

Patients spent 49% of the 44-week LTS periods between Weeks 8 and 52 off treatment due to lesion clearance.2,5

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

 

AFFECTED BSA THROUGH 1 YEAR2,5

Approximately 3 times reduction

Mean affected BSA in 
the OPZELURA group was 11.2% at baseline and 
2.9% at Week 8.5

Adapted from Eichenfield et al. EADV Congress. 2024.

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

*Week 12−52 data exclude 1 patient in the OPZELURA group who completed the study but did 
not receive treatment in the LTS period (maintained IGA and BSA of 0).2

†Vehicle group rerandomized to ruxolitinib 0.75% or OPZELURA at Week 8.2

AFFECTED BSA THROUGH 1 YEAR: GRAPHIC DESCRIPTION

The graph above shows the data for mean total affected BSA over 52 weeks. At Week 52, patients using OPZELURA had a mean total affected BSA of 1.9% vs. 1.6% for those who switched from vehicle to OPZELURA at Week 8. Please note that the number of patients in the extension part of the trial decreased over time.2

BID, twice daily; BSA, body surface area; LTS, long-term safety.

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VIEW SAFETY PROFILE
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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 2 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 (JAK) 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 JAK 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 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 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.

CYTOPENIAS

Thrombocytopenia, anemia, neutropenia, lymphopenia, and leukopenia 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. Discontinue OPZELURA if signs and/or symptoms associated with clinically significant decreases in laboratory values occur.

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, bronchitis, ear infection, eosinophil count increased, urticaria, diarrhea, folliculitis, tonsillitis, rhinorrhea, upper respiratory tract infection, COVID-19, application site reaction, pyrexia, and white blood cell decreased.

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 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 (JAK) 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 (JAK) 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. Eichenfield LF, Stein Gold LF, Simpson EL, et al. 52-week safety and disease control with ruxolitinib cream in children aged 2-11 years with atopic dermatitis: results from the phase 3 TRuE-AD3 study. Presented at the European Academy of Dermatology and Venereology Congress; September 25-28, 2024; Amsterdam, Netherlands. 3. Eichenfield LF, Stein Gold LF, Simpson EL, et al. Efficacy and safety of ruxolitinib cream in children aged 2 to 11 years with atopic dermatitis: Results from TRuE-AD3, a phase 3, randomized double-blind study. J Am Acad Dermatol. 2025;93(3):689-698. doi:10.1016/j.jaad.2025.05.1385 4. Kallender H. TRuE-AD3 supplemental data and PLS. Mendeley Data. 2025;V2. doi:10.17632/t4npyttrbf.2 5. Data on File. Incyte Corporation.