Vitiligo and the New FDA-Approved Drug Opzelura

Is it the solution?

Recently, there was some discussion on social media about a new FDA-approved drug known as OPZELURA for the treatment of vitiligo. 

We would like to share some information on this subject as vitiligo is something that we will be seeing more of, so it is critical for us to be updated on this subject and options for skin therapists

First, let’s look at the conditions and their manifestations.

Vitiligo is a relatively common condition in which the skin is unable to produce pigment. 

Pigment-forming cells (melanocytes) are destroyed and the skin becomes white.  All ethnic groups and approximately 1-2% of all people are affected by this condition.

What causes it?

The cause of vitiligo was considered unknown. However, recent studies indicate that it is an autoimmune condition where the body’s immune system attacks its own tissues. In vitiligo, pigment-forming cells are targeted. Individuals who are predisposed to developing the condition include:

• Hereditary: family history is present in 10% of cases.
• Injury to the skin
• Emotional factors
• Stress can trigger or aggravate the condition.

With the aftermath of COVID, we are also seeing a rise in autoimmune conditions with the prospect of vitiligo also manifesting at a growing rate.

What does it look like?

Vitiligo appears as white areas with sharp edges on the skin usually without any preceding inflammation occurring in the affected skin.  It is like the opposite of pigmentation where the skin becomes darker in patches, but with vitiligo, the skin loses pigment altogether and becomes very pale as if bleached.

Vitiligo can develop in areas of skin injury such as a cut or burn (including sunburn or an abrasion). The condition may be seen under the arms, in the groin, or between the buttocks where one skin surface rubs against another.

White hairs can occur on the scalp, eyelashes, eyebrows and beard. Eye involvement can also occur.

White areas of skin commonly start to appear in a person’s 20s and 30s, but for some people, these may first appear in childhood or later in adult life. The condition can get worse over time but the rate at which this happens varies from person to person.

Psychologically vitiligo can be devastating. Cosmetic disfigurement may cause major emotional trauma, and in certain cultures, people affected by vitiligo may be kept out of normal community activities.

What other problems can occur with this condition?

People affected with vitiligo may also develop other autoimmune diseases. Abnormalities in thyroid function are the most common ­­– the thyroid may be either overactive (Graves’ disease) or underactive (Hashimoto’s thyroiditis).  Other autoimmune diseases associated with vitiligo include diabetes mellitus and pernicious anaemia.

How is it diagnosed?

The diagnosis of vitiligo is based on clinical examination.  Blood investigations are performed to exclude the presence of thyroid disease, diabetes and pernicious anaemia.  Because if these possibilities if you have a client who is exhibiting vitiligo, it is advisable to encourage them to visit their doctor for an investigation of other health area concerns that may have been triggered.

Can it spread?

Vitiligo can remain localized and stable indefinitely, or it may progress slowly or rapidly. There is no way to predict this. Definitive factors that precipitate the progression of the disease are speculative-emotional distress, physical illness, severe sunburn and pregnancy are often implicated. Depigmented areas may sometimes spontaneously repigment.

How is it treated?

The treatment of vitiligo is frequently prolonged, and progress can be slow.  Complete re-pigmentation is not always achieved.

Psychological support plays an integral part in the treatment of people with vitiligo and some people may benefit from counselling.

Fair-skinned individuals may decide not to be treated at all as the contrast between the white areas and the natural skin colour may not be as obvious.

According to the Australian College of Dermatology treatment options include:

Cosmetic camouflage: Camouflage makeup applied to the white area is designed to be waterproof as well as blend well with the surrounding skin without appearing like makeup. 

While this may be a temporary measure, it can create immediate results and can be highly psychologically beneficial for the individual, as they can regain their self-esteem knowing that their condition is not easily detectable by others.  The camouflage option is a must, especially for people with small areas of vitiligo.

Topical treatments: Applying treatments that reduce the inflammation or destroy the pigment cells and/or encourage neighbouring cells to produce more pigment. Many of these are medical only as they are drug related.

These include:

• Topical cortisone creams or ointments

• Light therapy with narrow band UVB phototherapy

• Applying photosensitising psoralen drugs made up as creams to the white areas followed by careful sunlight exposure or UVA phototherapy

• Tacrolimus

• Pimecrolimus

• Calcipotriol.
  
  Active repigmentation: Active repigmentation involves the transfer of a person’s own pigment-forming cells (melanocytes) from pigmented skin into areas of skin affected by vitiligo.

Surgical treatments work best in small areas of pigment in people whose vitiligo is stable and not getting worse.

Depigmentation: In some people with widespread vitiligo, treatment with monobenzyl ether of hydroquinone is cosmetically more desirable as remaining pigment cells are destroyed and a more even appearance is created.

OPZELURA

Let’s look at Opzelura (Ruxolitinib) – it is a prescription cream for the topical treatment of nonsegmental vitiligo in patients aged 12 and older. Nonsegmental vitiligo is the most common type of vitiligo – where depigmented patches appear on both sides of the body, it is therefore designed for this specific type of vitiligo.

The latest studies on the use of ruxolitinib cream reflect a new understanding of vitiligo. It works by tamping down an overactive immune response.

Research has confirmed that ruxolibinib is better at modulating, and rebalancing the immune system, thus allowing a uniform flow of pigment throughout the skin. 

About 30% of the 450 people who received active treatment as part of two studies saw a dramatic improvement in facial pigmentation after six months.

Up to half did after a year of treatment, indicating that the cream became more potent over time. More than 80% of people in both trials were white and only 3% to 5% were Black or Asian. 

Ruxolitinib cream seems to work best on the head and neck, with hands and feet the hardest to repigment. It’s not yet known whether someone can take ruxolitinib for a period of time and then stop, or whether vitiligo will return without constant dosing. Formulated as a cream ruxolitinib does not affect the whole body, so side effects are relatively minor, usually just some acne where the cream is used.

However, other researchers state that the use of Opzelura along with therapeutic biologics, other JAK inhibitors, or strong immunosuppressants such as azathioprine or cyclosporine is not recommended. Therefore, there are risks if combined with other drugs.

While we know that the buzz around Opzelura cream is because it is the first and only FDA-approved prescription treatment for vitiligo repigmentation, however, there is no evidence that it is presently TGA-approved for use in Australia.

PRECAUTIONARY MEASURES

Unfortunately, the risk factors in using this drug are quite extensive and precautionary measures include: 

• Infections: Opzelura should not be used in people with an active, serious infection, including localised infections as they could be at higher risk of developing shingles (herpes zoster) while using Opzelura.

• 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 medicine in the class of medicines called JAK inhibitors by mouth, especially in current or past smokers.

• Blood clots: Blood clots in leg veins (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 (anaemia), and low white blood cell counts (neutropenia).

• Cholesterol increases: Cholesterol increase has happened in people when ruxolitinib is taken orally.

• 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 smokers. Some people have had skin cancers while using Opzelura.

NUTRITION AND NATURAL STRATEGIES

VITAMINS AND MINERALS: As with every other health condition, improving nutrition deficiencies can also help the condition of vitiligo.  Here are key nutrients that have been identified that are required for patients suffering from vitiligo and the progression of this condition.

Vitamin B12 and Folic Acid. A two-year study conducted at University Hospital in Sweden found that over half of the participants in the trial experienced repigmentation when combining vitamin B12, folic acid, and sun exposure.

The spread of vitiligo stopped in 64 percent of patients. Researchers note that the areas that received direct sunlight showed the most improvement.

Adding a variety of vitamin B12-rich foods and folate-rich foods are recommended.

Vitamin B12 is essential for those with vitiligo as it may help prevent depression, a common side effect of a vitiligo diagnosis. Folate is essential for overall health and wellness as it lowers the risk of heart disease, may prevent certain types of cancer and is essential for healthy pregnancies.

Zinc. Another common deficiency found in those with this condition is zinc. Zincsupports a healthy immune system, fights cancer, fights diabetes (an autoimmune condition commonly associated with vitiligo), supports proper nutrient absorption, and helps repair and heal muscles, tissues and bones.

Copper. While researchers disagree on whether copper deficiency causes vitiligo or is a result of vitiligo, adding copper-rich foods to your diet may be beneficial.

In Ayurveda practice, water is often kept in a copper vessel overnight prior to drinking. It is believed that copper stimulates the melanocytes into action, increasing melanin and repigmenting the skin.

Beta Carotene. For overall skin health, carotenoids are imperative. Beta-carotene, lutein, lycopene and zeaxanthin are found in great-tasting foods like sweet potatoes, carrots, kale and tomatoes.

Beta-carotene is associated with anticancer properties, lutein and zeaxanthin with eye health and lycopene with lower risk for prostate cancer. In addition, these powerful carotenoids may help lower inflammation, promote eye health, and protect the skin from damage, including melanoma.

Aloe Vera. Long used for skin health, aloe vera also supports a healthy immune system response. This powerful plant contains essential antioxidant vitamins needed when fighting vitiligo, including vitamins A, C, B12, and folic acid. It also contains essential minerals, including copper, calcium, chromium, zinc and others that may support repigmentation of the skin, making it a vital treatment for vitiligo.

Vitamin C. Like folic acid and vitamin B12, many vitiligo patients are also deficient in vitamin C. Vitamin C deficiency is more common than many believe and for vitiligo patients, it is essential to help slow cell damage, fight free radicals, and build the collagen necessary for healthy bones, joints, ligaments and skin. The best way to get the vitamin C you need is to eat fresh, organic fruits and vegetables.

But citrus fruits may not be the best choice for those with vitiligo as they may reduce pigmentation in some people.

Vitamin D. Many people with vitiligo are sensitive to the sun and some of the conventional treatments can cause severe sensitivity to the sun.

Because of this, incorporating plenty of vitamin D-rich foods into the diet is vital, and supplementation may be necessary. The best sources include cod liver oil; wild fish including sardines, salmon, mackerel and tuna; and raw milk, eggs and mushrooms.

Stress management. Stress, depression and anxiety are common with this condition.

Any modality that helps to lower stress levels such as massage, exercise and mindfulness practices on a regular basis can help improve mental focus and attitude and is also highly beneficial.