• Nonsegmental Vitiligo: Clinical Case Series

    PATIENT CASE STUDY FORM

  • 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 nonsegmental vitiligo (NSV) 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.     Aged 12 years or older, diagnosed with NSV
    2.     Have been treated with OPZELURA as monotherapy for NSV according to the USPI

  • 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 (JAK) inhibitors for inflammatory conditions are at risk for serious infections that may lead to hospitalization or death. These include:
    ·      Active tuberculosis, which may present with pulmonary or extrapulmonary disease.
    ·      Invasive fungal infections, including cryptococcosis and pneumocystosis.
    ·      Other bacterial or viral infections, including herpes zoster, 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

  • At diagnosis, this patient’s NSV was:*
  • At diagnosis, was a triggering event identified (eg, sunburn, chemical exposure, physical injury, significant event)?*
  • Do you know the circumstances that led to the patient's referral/decision to see you?*

  • Physical Exam and Medical History

  • Does the patient have vitiligo lesions with leukotrichia?*
  • Does this patient have a family history of vitiligo?*
  • Has the patient’s NSV been previously treated?*
  • Does the patient present with other autoimmune conditions?*

  • 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)*
  • Which of the above area(s) did you select for treatment initiation with OPZELURA? (Select all that apply)*

  • SECTION C. TREATMENT COURSE

  • Rows

  • Patient Photography

    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 vitiligo 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:

  • Image field 106
  • Image field 107
  • Image field 109
  • Image field 110
  • Upload High Resolution Photos (JPEG or HEIC file formats)
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  • 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.

  • Upload Patient Consent and HIPPA Authorization Forms (PDF File Format)
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  • 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?*

  • IMPORTANT SAFETY INFORMATION (cont’d)

    Avoid use in patients with an active, serious infection. If a serious infection develops, stop OPZELURA until the infection is controlled. Carefully consider the benefits and risks of treatment prior to use in patients with chronic or recurrent infection. Closely monitor patients for the development of signs 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; however, cases were reported in clinical trials of oral JAK inhibitors to treat inflammatory conditions. Consider evaluating patients for latent and active TB infection prior to treatment. Monitor patients for the development of signs and symptoms of TB.

    Viral reactivation, including cases of herpes virus reactivation, 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 is not recommended in patients with active hepatitis B or hepatitis C.

    POST-MARKETING SAFETY

    In a large randomized postmarketing safety study of rheumatoid arthritis (RA) patients 50 years and older with at least one cardiovascular risk factor, the following were higher with an oral JAK inhibitor than with a tumor necrosis factor (TNF) blocker:

    all-cause mortality, major adverse cardiovascular events (defined as cardiovascular death, myocardial infarction, and stroke), thrombosis, malignancies (excluding non-melanoma skin cancer [NMSC]).

    Consider the benefits and risks prior to initiating or continuing therapy with OPZELURA.
    Discontinue OPZELURA in patients who have experienced a myocardial infarction or stroke.

    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. Patients who are current or past smokers are at increased risk. Inform patients about the symptoms of serious cardiovascular events and the steps to take if they occur.

    Consider the benefits and risks prior to initiating therapy with OPZELURA, particularly in patients:

    • with a known malignancy (other than successfully treated non-melanoma skin cancers),
    • who develop a malignancy when on treatment,
    • with cardiovascular risk factors and
    • 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. Limit exposure to sunlight and UV light with protective clothing and broad-spectrum sunscreen.

     

    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. 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 patients who have a known history of these events prior to initiating therapy. Perform CBC monitoring as clinically indicated. Discontinue OPZELURA if symptoms associated with clinically significant decreases in laboratory values occur.

    POTENTIAL RISKS RELATED TO JAK INHIBITION

    Treatment with oral ruxolitinib has been associated with increases in lipid parameters including total cholesterol, low-density lipoprotein (LDL) cholesterol, and triglycerides, as well as hypoglycemia in patients with diabetes.

    ADVERSE REACTIONS

    In nonsegmental vitiligo, the most common adverse reactions (≥1%) are application site acne, application site pruritus, nasopharyngitis, headache, urinary tract infection, application site erythema, and pyrexia. 

    PREGNANCY REGISTRY

    There is a registry that monitors pregnancy outcomes in 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; NSV, nonsegmental vitiligo; tx, treatment; USPI, United States Prescribing Information.

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

    © 2026, Incyte. OPZ-1602 07/26

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