ITCH RESULTS

RAPID AND CLINICALLY MEANINGFUL ITCH RELIEF^1-3

Patient experiencing redness and itching on the neck

≥4-POINT IMPROVEMENT IN ITCH (ITCH NRS4^*) AT WEEK 8^1-3

>50% of patients achieved a clinically meaningful improvement in itch* at Week 8^1-3

Adapted from Papp K et al. doi:10.17632/ffx6nd5zyb.1. Licensed under CC BY 4.0

ITCH NRS4 AT WEEK 8: CHART DESCRIPTION

The line graph above shows the proportion of Itch NRS4 responders for OPZELURA and vehicle from the TRuE-AD1 and TRuE-AD2 clinical trials from Week 0 to Week 8. At Week 8, 52.2% of patients taking OPZELURA achieved a 4-point improvement in itch vs. 15.4% for vehicle in TRuE-AD1. In TRuE-AD2, 50.7% of patients taking OPZELURA achieved a 4-point improvement in itch vs. 16.3% for vehicle. There were 37% more responders vs. vehicle.^1-3

RAPID IMPACT ON ITCH

>30% of patients achieved Itch NRS4* at Week 2 (33.5% vs. 5.1% and 32.2% vs. 5.0%)^2,3

POST-HOC, EXPLORATORY ANALYSIS

Difference in Itch NRS4 was observed as early as Day 2 (NRS ≥ 4; 11.6% vs. 2.9% and 10.8% vs. 1.3%)^4,5

*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.^1,2

BID, twice daily; NRS, numerical rating scale.

CHANGE IN ITCH NRS^‡ THROUGH WEEK 8²

ADDITIONAL EXPLORATORY ANALYSIS

Patient-reported change in Itch NRS score observed as early as day 1 and through day 56²

Results were not adjusted for multiple comparisons.

Adapted with permission from Papp K et al. J Am Acad Dermatol. doi:10.1016/j.jaad.2021.04.085

CHANGE IN ITCH NRS THROUGH WEEK 8: CHART DESCRIPTION CHANGE IN ITCH NRS THROUGH DAY 56: CHART DESCRIPTION

The line graph above shows the mean reduction in Itch NRS from the TRuE-AD1 and TRuE-AD2 clinical trials from Day 0 to Day 56. In TRuE-AD1 and TRuE-AD2, respectively, patients taking OPZELURA experienced a 3.53% and 3.17% reduction in itch by Day 56 vs. 1.51% and 1.33% for those taking the vehicle.

^‡For Itch NRS assessment, patients completed an electronic diary each evening, reporting their worst level of itch during each 24-hour period from 0 (no itch) to 10 (worst imaginable itch).

BID, twice daily; NRS, numerical rating scale.

Additional Exploratory Analysis

PATIENTS ACHIEVING ITCH NRS 0/1* IN THE FIRST 7 DAYS⁶

DAILY PROPORTION OF PATIENTS ACHIEVING ITCH NRS 0/1* IN THE FIRST 7 DAYS–POOLED ANALYSIS⁶

DAILY PROPORTION OF PATIENTS ACHIEVING ITCH NRS 0/1* IN THE FIRST 7 DAYS: CHART DESCRIPTION

The line graph above shows the proportion of clinical trial participants who achieved Itch NRS 0/1 in the first 7 days of treatment. 36.0% of patients taking OPZELURA showed Itch NRS 0/1 at Day 7 vs. 9.2% for vehicle.

*Patients in the analysis had an Itch NRS score >1 at baseline.

BL, baseline; NRS, numerical rating scale.

Patient experiencing redness and itching on the cheek

In a pooled analysis the proportion of patients who showed Itch NRS 0/1* at Day 7 was 36.0% (and 9.2% vehicle)⁶

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

*Patients in the analysis had an Itch NRS score >1 at baseline.

NRS, numerical rating scale.

VIEW SKIN CLEARANCE DATA

VIEW PATIENT SELECTION

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

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.

RAPID AND CLINICALLY MEANINGFUL ITCH RELIEF^1-3

RAPID IMPACT ON ITCH