The Food and Drug Administration (FDA) approved ruxolitinib (Opzelura) cream 1.5 percent on July 18, according to a statement from Incyte, the manufacturer of the drug.
Vitiligo is an autoimmune condition that causes patches of skin to lose pigment and turn milky white. Nonsegmental (or generalized) vitiligo is the most common form, where white patches appear symmetrically on both sides of the body, such as on both hands or both knees, and can be large in size.
Ruxolitinib is the first medication to restore pigment in patients with nonsegmental vitiligo. The FDA approved Incyte’s ruxolitinib cream for adults and children 12 and older.
According to Dr. Daniel Gutierrez, assistant professor of dermatology at NYU Grossman School of Medicine and dermatologist at NYU Langone Health in New York City, who was not involved with the development of the drug, “this approval is monumental.” using Opzelura, we will have a vitiligo treatment option that is FDA-approved for regaining color in patients suffering from vitiligo, says Dr. Gutierrez.
In the past, the only FDA-approved medication for vitiligo was monobenzyl ether of hydroquinone, a topical medicine that removes pigment from the skin to even out the tone.
What is vitiligo?
Approximately 1.9 to 2.8 million adults in the United States have vitiligo, with perhaps 40 percent going undiagnosed.
According to the National Institute of Arthritis and Musculoskeletal and Skin Diseases, vitiligo causes immune cells to destroy melanocytes, the cells that produce pigment. Gutierrez explains, “This makes vitiligo more visible because there is a greater contrast between the unaffected skin and the skin affected by vitiligo.”
People can develop vitiligo at any age, but most develop it before they reach their 30s.
Within one year, 50 percent of people who used ruxolitinib experienced significant repigmentation
Ruxolitinib belongs to a class of drugs known as Janus kinase (JAK) inhibitors. Unlike oral JAK inhibitors which are prescribed by doctors for diseases such as rheumatoid arthritis, ruxolitinib is the only JAK inhibitor approved for topical application in the United States.
In the fall of 2021, the FDA approved ruxolitinib for mild to moderate atopic dermatitis (eczema).
Inhibitors of JAK work by suppressing the immune system, blocking some enzymes that cause inflammation.
Ruxolitinib is applied twice daily to the affected areas, covering up to 10 percent of the body’s surface. It may take 24 weeks or longer for people with vitiligo to see satisfactory results, according to Incyte.
FDA approval was based on data from a clinical trial that compared ruxolitinib to a placebo cream in more than 600 people (age 12 and older) with nonsegmental vitiligo. Researchers used the Vitiligo Area Scoring Index (VASI), a measure of disease severity and of improvements in repigmentation on the face and body.
By week 24, approximately 30 percent of the people treated with ruxolitinib showed significant improvements (at least 75 percent) as measured by VASI, which was the study’s goal. A year later, about 50 percent of those using the medication had achieved this level of repigmentation.
“Gutierrez says that”,Opzelura users saw much greater improvements in vitiligo compared with placebo users.
The most common side effects in the trials were acne, redness, itchiness, pharynx and nasal cavity inflammation, headache, urinary tract infection, and fever.
Black Box Warning for Ruxolitinib
Based on data showing that patients taking oral JAK inhibitors faced a small increased risk of serious infections, major heart issues, clotting (thrombosis), cancer, and even death, the FDA added a black box warning to ruxolitinib.
it has been noted in the clinical trials for people using ruxolitinib as a topical cream that the concentration of the drug found in their blood was much lower than that of people taking it orally,” Gutierrez reports. The same risks were not observed in the ruxolitinib trials, but the FDA is now requiring a warning label on the box, he adds.
It is best to discuss the benefits and risks of ruxolitinib with your healthcare provider, as well as the need for baseline and ongoing monitoring.
Patients Can Use Ruxolitinib on Their Face
While dermatologists prescribe topical steroids off-label for vitiligo, there are risks associated with applying these medications to the face – the area where loss of pigment can be most noticeable, says Gutierrez.
On the face, topical steroids can result in a rash similar to acne that can persist for months, known as perioral dermatitis. Plus, they can cause atrophy or dispigmentation, so your skin color may change. Additionally, they can thin the skin, cause stretch marks, and cause the growth of small blood vessels in the area,” Gutierrez says.
Is not associated with these risks, Gutierrez notes.
FDA approval means better access to treatments for vitiligo
Due to the FDA’s approval of ruxolitinib, it will definitely improve access to the drug by proving that it is medically necessary. the fact that vitiligo just changes the color of the skin – there’s no itching or dermatitis under normal conditions – allows it to sometimes be considered a cosmetic condition, meaning no treatment is needed,” Gutierrez says. According to the Vitiligo Research Foundation, some insurers have declined to cover vitiligo treatments.
“This condition, however, can have grave effects on how a patient views themselves and how they present themselves to the outside world”. Vitiligo can cause significant psychological distress and negatively impact quality of life,” says Gutierrez.
Vitiligo disproportionately affects patients of color, He says. “This approval will help close the health disparity that exists, and hopefully more treatment options for vitiligo will be available in the future.”
Ruxolitinib Cost: How Much Does It Cost?
A 60 gram tube of Opzelura currently costs $1,950 based on wholesale acquisition cost, according to Gabriella Greig, spokesperson for Incyte. The actual cost to the consumer will vary depending on insurance coverage and how much cream is needed.
“Inncyte is committed to working with insurance providers in the U.S. to ensure that eligible patients who can benefit from its products have access to them”, says Greig. For people with commercial insurance, the company offers a copay savings card on its website.