People with vitiligo often need to use many medicines every day to help regain pigment in their skin and reduce other side effects. Some people may use light therapy, pills, or surgery to help reverse the symptoms. Other treatments, like lotions and creams, can be applied directly to the affected areas, known as topical medicines. The goal is to block your overactive immune system.
Janus kinase (JAK) inhibitors are newer medicines that block a specific piece of your overactive immune system to regain pigment and control symptoms. Opzelura is the first and only JAK inhibitor for regaining pigment in the most common type of vitiligo, non-segmental vitiligo.
How Does Opzelura Work?
Vitiligo is a long-term (chronic) condition where you lose color (pigment) in your skin. This is due to an overactive immune system. The immune system attacks your skin color cells (melanocytes), making your skin look white or pink in patchy areas. Some people have more patches of color loss or will have color loss on specific sides of the body. This can happen anywhere on the body and can cause:
- Sensitivity to light and a higher skin cancer risk
- Color change in your hair (early graying) or in your retina
- Hearing loss
- Mental health problems, like low self-esteem, depression, anxiety, or social isolation
- Itching or sensitivity in the patches that lost color
- Change to the way you sweat
Opzelura is a JAK inhibitor cream that is used for regaining skin color (repigmentation). JAK inhibitors block the overactive signals in the JAK-STAT pathway of your immune system. This can help increase the number of melanocytes and reduce skin color loss. JAK inhibitors are commonly used for moderate to severe atopic dermatitis for people who have not had a response to other topical treatments. They can also help people who have not had a response to other oral or injected immune-suppressing medicines or cannot take them.
How Should I Use This Medicine?
Opzelura is a cream that is applied as a thin layer, twice a day, on the areas of skin color loss.
Talk with your pharmacist or other health care provider if you have questions about how and where to use Opzelura. It is important to wash your hands after applying the cream, unless you are putting on a spot on your hands. Do not cover the affected area with a bandage or other wrap, unless your health care provider tells you to. If you are using other topical medicines or moisturizers, talk to your health care provider about what to continue and how to use them along with Opzelura.
How Was It Studied for Vitiligo?
Two studies were done to see if Opzelura was safe and effective for the treatment of vitiligo, compared with a placebo. Placebo-controlled studies help researchers see differences in benefit or harm of a medicine when compared with no treatment. People in both studies had small areas of non-segmental vitiligo, including the face and other areas of the body. The severity of the vitiligo on the total body and face was measured by the Vitiligo Area Scoring Index (VASI, see table below).
| Scale | Score Range | Meaning |
Facial Vitiligo Area Scoring Index (F-VASI) | 0 – 5 | 0 = No depigmentation 5 = Depigmentation of the entire face |
Total Vitiligo Area Scoring Index (T-VASI) | 0 – 100 | 0 = No depigmentation 50 = Depigmentation of 50% of the body 100 = Depigmentation of the entire body |
People in the studies had to be at least 12 years old. The average age was 40 years, with about 10% of the people being younger than 18. A little over half of the people were female, with most people being White (about 80%). The average length of their disease was 13 years, with one-third of people diagnosed as a child. Most people in the studies had stable vitiligo.
People in both studies had to have an F-VASI score of 0.5 or higher and a T-VASI score of 3 or higher. The average VASI scores and percentage of the body affected are shown in the table below:
| T-VASI = 6.5 | Total % Body = 7.26% |
| F-VASI = 1.0 | Total % Face = 1.09% |
Efficacy in both studies were based on 75% or 90% decreases in the F-VASI scores from the original measurements at the beginning of the study. A decrease in these scores means that the depigmentation is less, and skin color is returning in those areas. After 24 weeks of treatment, people could continue to use Opzelura for 28 more weeks.
What Benefits Were Seen in the Studies?
After 24 weeks of treatment, people using Opzelura were more likely to have decreases in VASI scores, meaning more visible repigmentation in the face and total body areas.
- On average, 30% of people using Opzelura had over 75% improvement in F-VASI scores, compared with 8%-11% of people using a placebo.
- On average, 15% of people using Opzelura had over 90% improvement in F-VASI scores, compared to 2% of people using a placebo.
At the end of 52 weeks for both studies, the number of people who had visible pigment changes increased to 48%-52%. About 30% of people who switched from a placebo to Opzelura after 24 weeks had more pigment improvements by the end of 52 weeks. Many people continued to see improvements up to two years using Opzelura, twice daily.
Your results may differ from what was seen in clinical studies. You and your health care provider should determine if the benefits outweigh any potential risks.
When Will the Medicine Start Working?
If Opzelura is working, you should start to see repigmentation after two to three months of regular use. It could take up to six months to see meaningful changes in skin color. In some areas of the body, like the face, you may see faster changes. People sometimes notice tiny spots of pigment in the white patches (perifollicular repigmentation). It is a slow process, and continued treatment is needed to see more results.
Contact your health care provider if you don’t see improvements after three months or continue to have symptoms that bother you. Do not stop using Opzelura without talking with your health care provider. If you stop Opzelura, you may see more skin color loss.
Are There Reasons I Should Not Use This Medicine?
Opzelura should not be used when you have an active infection. Talk to your health care provider about any of the following:
How Can I Prevent and Manage Side Effects?
The most common side effects are infections in the nose or throat, a sore throat, or common cold symptoms. These can also include serious infections. The best way to prevent infections is to reduce your exposure to germs by washing your hands and avoiding people who are sick. You should stay current on vaccinations, such as getting an annual flu vaccine. Call your health care provider if you have these symptoms of infection:
- Fever or chills
- Body aches
- Coughing
- Tiredness
- Persistent headache
- Confusion
- Vision changes
- Painful rash
- Painful urination or a frequent need to pee
These are not all of the possible side effects. Talk with your health care provider if you are having symptoms that bother you. In the U.S., you can report side effects to the FDA at www.fda.gov/medwatch or by calling 800-FDA-1088 (800-332-1088). In Canada, you can report side effects to Health Canada at www.health.gc.ca/medeffect or by calling 866-234-2345.
What Types of Interactions Can Happen?
Several medicines can affect the blood levels of Opzelura. This may increase the risk of side effects. The following medicines should be avoided. Talk with your health care provider if you are using any of the following medicines or foods:
- Strong CYP3A4 inhibitors, which include ceritinib (Zykadia), clarithromycin (Biaxin), idelalisib (Zydelig), itraconazole (Sporanox, Tolsura), and ketoconazole (Nizoral)
- Medicines used for HIV (like, indinavir/ritonavir, elvitegravir/ritonavir)
- Grapefruit or grapefruit juice
This is not a complete list of medicines that may interact with Opzelura. Tell your pharmacist or other health care provider about all the prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, or other supplements you take or have recently taken. This will help them determine if there are any interactions, or if you need to change your dose.
Getting Your Medicine: What to Expect
Depending on your prescription insurance, Opzelura may be considered a specialty medicine, which is a high-cost medication that is taken for rare, complex, or chronic diseases. It may require a different process than picking up a prescription at your local pharmacy. This process helps you stay on track with your treatment. The drugmaker has a program to help support the process, or your insurance company may require a specific pharmacy.
Here are some differences that you may expect.
Insurance approval. Your insurance may require approval for using this medicine, also called a prior authorization. The insurance company reviews the prescription from your health care provider to make sure it is covered and determines the process that needs to be followed.
Pharmacy access. You may be required to use a specific pharmacy to get your medicine. Your health care provider will work with you and your insurance company on which pharmacy to use and the information that will be provided.
Copay assistance. There is a copay assistance program from the drugmaker that may allow you to pay $0 for your prescription. Whether you are eligible depends on whether you have prescription insurance and what type of insurance you have. You can find out more at https://www.opzelura.com/atopic-dermatitis/copay-savings-program or by calling 833-613-2333.
