Vitiligo: What to know about this chronic autoimmune skin condition
(BPT) - By Brandpoint
Sponsored by Incyte Corporation
You might have heard of vitiligo, a chronic autoimmune skin condition characterized by depigmentation (loss of color) of skin that affects approximately 2-3 million people in the United States1, with more than 1.5 million people diagnosed2. But you might not know what causes this condition, the significant impact it has on those affected, or how it is managed.
In fact, there are a number of misconceptions about vitiligo, and Dr. David Rosmarin, a dermatologist and Vice Chair of Research and Education, Department of Dermatology at Tufts Medical Center, helps debunk some of the most common myths associated with the condition.
Setting the Record Straight for Common Vitiligo Misconceptions
Misconception #1: Vitiligo is merely a cosmetic condition
“Vitiligo is an autoimmune condition in which the immune system attacks and destroys pigment-producing cells, resulting in skin depigmentation in the form of white patches on the face and body3,” says Dr. Rosmarin. “People with vitiligo are also more likely to have other medical conditions, or comorbidities. For example, over 15% of people with vitiligo are also living with another autoimmune disorder, such as thyroid disease, rheumatoid arthritis, lupus or Type 1 diabetes4.”
Misconception #2: Vitiligo only affects darker skin
“Vitiligo affects individuals of all races, cultures, ages and genders,” explains Dr. Rosmarin. “The condition occurs with similar frequency in all ethnic groups5.”
Misconception #3: There is only one way to manage vitiligo
“Everyone’s experience with and approach to managing vitiligo is unique,” notes Dr. Rosmarin. “Some people with vitiligo feel confident and embrace their skin. But others want to seek treatment, and I encourage those people to talk to their dermatologist about their management goals and determine the treatment course that is right for them.”
Misconception #4: There is nothing doctors can do for people with vitiligo seeking repigmentation
Dermatologists approach vitiligo treatment in a variety of ways and treatments plans should be individualized to the patient's condition and unique experience.
“For certain people 12 years of age and older with nonsegmental vitiligo who are interested in treatment, a new topical option, Opzelura, has been approved by the U.S. Food and Drug Administration (FDA),” says Dr. Rosmarin. “This is particularly exciting for the vitiligo community, as there were previously no FDA-approved treatment options available for vitiligo repigmentation.”
New FDA-Approved Treatment for Vitiligo
Recently, Opzelura™ (ruxolitinib) cream was approved by the FDA for the topical treatment of nonsegmental vitiligo in adult and pediatric patients 12 years of age and older. Opzelura is a nonsteroidal cream that is applied twice daily to the skin. It is the first and only FDA-approved treatment for vitiligo repigmentation. Opzelura has a boxed warning with information about risks for serious side effects.
Results from two Phase 3 clinical trials showed that patients treated with Opzelura experienced significant improvements in facial and total body repigmentation, as shown by VASI scores, at Week 24 compared to vehicle (a cream that did not contain the active drug), with continued improvements in response rates with longer duration of treatment at Week 52.
At Week 24, nearly 1 in 3 patients treated with Opzelura achieved a 75% improvement from baseline in the facial Vitiligo Area Scoring Index (F-VASI75), compared to approximately 8% and 13% of patients treated with vehicle. At Week 52, approximately half of Opzelura-treated patients achieved a 75% improvement in facial repigmentation. People with vitiligo may need to be treated with Opzelura for more than 24 weeks to see a satisfactory response6.
The most common side effects of Opzelura in people treated for nonsegmental vitiligo include: acne at the application site, itching at the application site, common cold (nasopharyngitis), headache, urinary tract infection, redness at the application site, and fever7. Opzelura may cause serious side effects including serious infections, increased risk of death from all causes, cancer and immune system problems, increased risk of major cardiovascular events, and blood clots.
“People with vitiligo should feel empowered to talk to a dermatologist if they want to take action,” says Dr. Rosmarin. “Having that open dialogue with a health care provider can help people with vitiligo find an individualized treatment approach that’s right for them.”
Opzelura may work for some, but not all, patients. To learn more, visit www.Opzelura.com.
INDICATION AND USAGE
OPZELURA is a prescription medicine used on the skin (topical) for the treatment of a type of vitiligo called nonsegmental vitiligo in adults and children 12 years of age and older.
The use of OPZELURA along with therapeutic biologics, other JAK inhibitors, or strong immunosuppressants such as azathioprine or cyclosporine is not recommended.
It is not known if OPZELURA is safe and effective in children less than 12 years of age with nonsegmental vitiligo.
IMPORTANT SAFETY INFORMATION
OPZELURA is for use on the skin only. Do not use OPZELURA in your eyes, mouth, or vagina.
OPZELURA may cause serious side effects, including:
Serious Infections: OPZELURA contains ruxolitinib. Ruxolitinib belongs to a class of medicines called Janus kinase (JAK) inhibitors. JAK inhibitors are medicines that affect your immune system. JAK inhibitors can lower the ability of your immune system to fight infections. Some people have had serious infections while taking JAK inhibitors by mouth, including tuberculosis (TB), and infections caused by bacteria, fungi, or viruses that can spread throughout the body. Some people have been hospitalized or died from these infections. Some people have had serious infections of their lungs while taking OPZELURA. Your healthcare provider should watch you closely for signs and symptoms of TB during treatment with OPZELURA.
OPZELURA should not be used in people with an active, serious infection, including localized infections. You should not start using OPZELURA if you have any kind of infection unless your healthcare provider tells you it is okay. You may be at a higher risk of developing shingles (herpes zoster) while using OPZELURA.
Increased risk of death due to any reason (all causes): Increased risk of death has happened in people 50 years of age and older who have at least 1 heart disease (cardiovascular) risk factor and are taking a medicine in the class of medicines called JAK inhibitors by mouth.
Cancer and immune system problems: OPZELURA may increase your risk of certain cancers by changing the way your immune system works. Lymphoma and other cancers have happened in people taking a medicine in the class of medicines called JAK inhibitors by mouth. People taking JAK inhibitors by mouth have a higher risk of certain cancers including lymphoma and lung cancer, especially if they are a current or past smoker. Some people have had skin cancers while using OPZELURA. Your healthcare provider will regularly check your skin during your treatment with OPZELURA. Limit the amount of time you spend in the sunlight. Wear protective clothing when you are in the sun and use a broad-spectrum sunscreen.
Increased risk of major cardiovascular events: Increased risk of major cardiovascular events such as heart attack, stroke, or death have happened in people 50 years of age and older who have at least 1 heart disease (cardiovascular) risk factor and taking a medicine in the class of medicines called JAK inhibitors by mouth, especially in current or past smokers.
Blood clots: Blood clots in the veins of your legs (deep vein thrombosis, DVT) or lungs (pulmonary embolism, PE) can happen in some people taking OPZELURA. This may be life-threatening. Blood clots in the vein of the legs (deep vein thrombosis, DVT) and lungs (pulmonary embolism, PE) have happened more often in people who are 50 years of age and older and with at least 1 heart disease (cardiovascular) risk factor taking a medicine in the class of medicines called JAK inhibitors by mouth.
Low blood cell counts: OPZELURA may cause low platelet counts (thrombocytopenia), low red blood cell counts (anemia), and low white blood cell counts (neutropenia). If needed, your healthcare provider will do a blood test to check your blood cell counts during your treatment with OPZELURA and may stop your treatment if signs or symptoms of low blood cell counts happen.
Cholesterol increases: Cholesterol increase has happened in people when ruxolitinib is taken by mouth. Tell your healthcare provider if you have high cholesterol or triglycerides.
Before starting OPZELURA, tell your healthcare provider if you:
- have an infection, are being treated for one, or have had an infection that does not go away or keeps coming back
- have diabetes, chronic lung disease, HIV, or a weak immune system
- have TB or have been in close contact with someone with TB
- have had shingles (herpes zoster)
- have or have had hepatitis B or C
- live, have lived in, or have traveled to certain parts of the country (such as the Ohio and Mississippi River valleys and the Southwest) where there is an increased chance for getting certain kinds of fungal infections. These infections may happen or become more severe if you use OPZELURA. Ask your healthcare provider if you do not know if you have lived in an area where these infections are common.
- think you have an infection or have symptoms of an infection such as: fever, sweating, or chills, muscle aches, cough or shortness of breath, blood in your phlegm, weight loss, warm, red, or painful skin or sores on your body, diarrhea or stomach pain, burning when you urinate or urinating more often than usual, feeling very tired.
- have ever had any type of cancer, or are a current or past smoker
- have had a heart attack, other heart problems, or a stroke
- have had blood clots in the veins of your legs or lungs in the past
- have high cholesterol or triglycerides
- have or have had low white or red blood cell counts
- are pregnant or plan to become pregnant. It is not known if OPZELURA will harm your unborn baby. There is a pregnancy exposure registry for individuals who use OPZELURA during pregnancy. The purpose of this registry is to collect information about the health of you and your baby. If you become exposed to OPZELURA during pregnancy, you and your healthcare provider should report exposure to Incyte Corporation at 1-855-463-3463.
- are breastfeeding or plan to breastfeed. It is not known if OPZELURA passes into your breast milk. Do not breastfeed during treatment with OPZELURA and for about 4 weeks after the last dose.
After starting OPZELURA:
- Call your healthcare provider right away if you have any symptoms of an infection. OPZELURA can make you more likely to get infections or make worse any infections that you have.
- Get emergency help right away if you have any symptoms of a heart attack or stroke while using OPZELURA, including:
- discomfort in the center of your chest that lasts for more than a few minutes, or that goes away and comes back
- severe tightness, pain, pressure, or heaviness in your chest, throat, neck, or jaw
- pain or discomfort in your arms, back, neck, jaw, or stomach
- shortness of breath with or without chest discomfort
- breaking out in a cold sweat
- nausea or vomiting
- feeling lightheaded
- weakness in one part or on one side of your body
- slurred speech
- Tell your healthcare provider right away if you have any signs and symptoms of blood clots during treatment with OPZELURA, including: swelling, pain, or tenderness in one or both legs, sudden, unexplained chest or upper back pain, or shortness of breath or difficulty breathing.
- Tell your healthcare provider right away if you develop or have worsening of any symptoms of low blood cell counts, such as: unusual bleeding, bruising, tiredness, shortness of breath, or fever.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
The most common side effects of OPZELURA in people treated for nonsegmental vitiligo include: acne at the application site, itching at the application site, common cold (nasopharyngitis), headache, urinary tract infection, redness at the application site, and fever.
These are not all of the possible side effects of OPZELURA. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects to Incyte Corporation at 1-855-463-3463.
© 2022, Incyte Corporation. MAT-OPZ-00521 07/22
1 Gandhi K, et al. Prevalence of vitiligo among adults in the United States. JAMA Dermatol. 2022;158(1):43-50.
2 Bergqvist C, Ezzedine K. Vitiligo: A Review. Dermatology 2020;236:571-592.
3 Rodrigues M, Ezzedine K, Hamzavi I, et al. New discoveries in the pathogenesis and classification of vitiligo. J Am Acad Dermatol. 2017;77:113.
4 Hadi A, Wang JF, Uppal P, et al. Comorbid diseases of vitiligo: a 10-year cross-sectional retrospective study of an urban US population. J Am Acad Dermatol. 2019;82(3):628633.
5 Cleveland Clinic. Vitiligo: https://my.clevelandclinic.org/health/diseases/12419-vitiligo. Accessed July 14, 2022.
6 Rosmarin D, Pandya AG, Grimes P, et al. Efficacy and safety of ruxolitinib cream for the treatment of vitiligo: 24-week results from 2 randomized, double-blind phase 3 studies. Presented at the 30th EADV Congress, September 29 - October 2, 2022.
7 Opzelura Prescribing Information. Wilmington, DE. Incyte Corporation.