Mild to Moderate Atopic Dermatitis: Clinical Case Series

Physician Name

By completing and submitting this Form, you represent that this Form is and shall remain compliant with the Health Insurance Portability and Accountability Act of 1996 and all regulations promulgated under that Act (collectively, “HIPAA”). By submitting this Form, you represent that all of your responses are HIPAA compliant and do not contain any individually identifiable health information.

IMPORTANT NOTE:

The case studies that will be developed based on this patient case study form will explore the management of patients with mild to moderate atopic dermatitis (AD) on OPZELURA® (ruxolitinib) cream 1.5%. All cases will require high quality, consistent photo documentation of patients at treatment initiation and throughout treatment.

Case Selection Criteria
All submitted cases should reflect patients who meet the following criteria:
1. Non-immunocompromised, aged 2 years or older, diagnosed with mild to moderate AD whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable
2. Have been treated with OPZELURA as monotherapy for mild to moderate AD up to 20% BSA according to the USPI

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.

Please see additional Important Safety Information, including Boxed Warning, at the end of this form.

SECTION A. CASE HISTORY
Case Demographics

Patient's First Name

Patient's Current Age

Sex

Fitzpatrick skin type

Ethnicity

Occupation (if pediatric patient, please answer N/A)

Month/Year of AD diagnosis

Age at diagnosis of AD

Duration of disease (years)

Do you know the circumstances that led to the patient's/caregiver's referral/decision to see you?

If you selected "significant life event", please describe

If you selected "other", please describe

Medical History

Has the patient’s AD been previously treated?

If "yes", what were those treatments?

How long were they utilized?

What level of efficacy, if any, was observed using these treatments?

Does the patient present with other autoimmune/allergy conditions or other relevant comorbidities? (Select all that apply)

If "other" please provide additional context here

Are any of the patient’s daily activities affected by their AD or do any of their daily activities exacerbate their AD? (Select all that apply)

If "other" please provide additional context here

SECTION B. PATIENT PRESENTATION AT TREATMENT INITIATION
Please provide the following clinical information for the patient at treatment initiation

Initial Presentation

Prior to OPZELURA initiation, what was the patient’s affected body region(s)? (Select all that apply)

If the patient has lesions that you are choosing not to treat, what are they and why?

What is the patient’s current total affected BSA?

Is the patient currently experiencing a flare?

Please provide details on the patient's itch experience in the follow domains, if available.

a. Itch Severity: What is the patient’s current experience with itch? Please rate on a scale of 0 to 10.

b. Sleep disturbance: Over the last week, on how many nights has the patient’s sleep been disturbed because of itch?

c. Quality of life impact: What is the impact of itch on the patient's quality of life? Please rate on a scale of 0 to 10.

d. Please provide any additional detail on the patient’s itch experience.

SECTION C. TREATMENT COURSE

Please provide information about the patient’s treatment course after OPZELURA initiation. Note: All documented visits where photos were taken must match the photos that are provided

Rows	Date	Time since tx initiation (weeks)	Provide all affected regions (including total BSA)	Observed side effects	Did you observe the patient’s AD improve in the treated areas?	Has the patient experienced an improvement in their itch? Please describe.	Did you change anything about the patient’s treatment plan during this visit? (eg, different lesions targeted)	Were photos captured at this visit? (Y/N)	Additional notes
Visit # 1
Visit # 2
Visit # 3
Visit # 4
VIsit # 5
Visit # 6

Please provide a direct patient/caregiver quote regarding their experience using OPZELURA and their impressions of the results that they have seen/felt with regards to skin lesion clearance, itch relief, quality of life improvement, and/or speed of response.

Please provide any additional detail (eg, patient/caregiver impressions about treatment results, when noticeable itch improvement was first observed, and/or any new medical comorbidities).

Patient Photography

Please upload corresponding photography for each visit noted above.

Photos must be:

High resolution – (The photo is large in size and crisp and clear to the eye)
JPEG or HEIC file formats
Captured with consistent lighting
Captured with consistent framing (both position/angle of the patient’s body part and AD lesion)
Captured with consistent background

Please ensure all files are named with important identifying information including your name and the patient’s first name. Additionally, please provide timestamps (ie, week 2, 4, 6, etc.) with the photos.

Examples:

File Upload

Patient Permissions

Please upload the completed Patient Consent Form and completed HIPPA Authorization below.

These forms can be found on pages 11-13 of your contract. If you are having difficulty locating the forms, please reach out to incyteteam@scientificglobal.com for assistance.

Please ensure all files are named with important identifying information including your name and the patient’s first name.

File Upload

If this case is approved, do you agree to allow Incyte to acknowledge you by name in materials that reference the case study and display the patient's photos.

I have completed this form and attest that it accurately and truthfully reflects my treatment of the patient described.

IMPORTANT SAFETY INFORMATION (cont’d)

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.

Abbreviations: HIPAA, Health Insurance Portability and Accountability Act; tx, treatment; USPI, United States Prescribing Information.

OPZELURA is a registered trademark of Incyte.
Incyte and the Incyte logo are registered trademarks of Incyte.