A couple of weeks ago, biopharmaceutical company Incyte announced its new FDA-approved topical cream called Opzelura (ruxolitinib) for the short-term and noncontinuous treatment of mild-to-moderate atopic dermatitis in non-immunocompromised patients age 12 and older whose disease is not adequately controlled with topical prescription therapies, or when those therapies are not advisable.
According to the National Eczema Association, atopic dermatitis (AD) is the most the most common type of eczema, affecting more than 9.6 million children and about 16.5 million adults in the United States. “It’s a common chronic skin condition characterized by skin inflammation and itch,” says New York dermatologist Dr. Amy Spizuoco. “Atopic dermatitis can be difficult to manage, but it is treatable. Unfortunately, many people do not respond well to current treatments or lose treatment response over time, and as a result, they tend to cycle through therapies, underscoring the need for new treatment options.”
That’s where Opzelura comes in: “It’s the first and only topical JAK inhibitor approved in the United States, and research shows JAK signaling is important in immune function,” says Dr. Spizuoco. According to Incyte, data reveals that the dysregulation of the JAK-STAT pathway contributes to key features of atopic dermatitis, such as itch, inflammation and skin barrier dysfunction that can be painful and frustrating.
However, some dermatologists are hesitant about the new drug, as the FDA labeled it with a black box warning—the same one used on oral JAK drugs—about serious infection, death, cancer, heart-related issues, and blood clots. “As a JAK inhibitor, I am aware of safety warnings for Opzelura, and I will carefully review risk factors with my patients to evaluate if this is appropriate therapy,” says Dr. Spizuoco. “Overall, this approval represents an important advancement for patients and their healthcare providers. We are fortunate to have a new treatment available, and I’m excited to have Opzelura as an option for some of my adolescent and adult patients with the disease.”
Now, Incyte is also announcing promising results from the Phase 3 TRuE-V clinical trial program evaluating the cream’s effects on adolescent and adult patients with nonsegmental vitiligo, a chronic autoimmune disease involving the depigmentation of skin that results from the loss of pigment-producing cells known as melanocytes.
Findings revealed that twice-daily treatment with 1.5% ruxolitinib cream resulted in facial repigmentation after 52 weeks: 50 percent of patients achieved greater than 75-percent improvement; 75 percent of patients achieved greater than 50-percent improvement; and 30 percent of patients achieved more than 90-percent improvement. A significant proportion of patients also achieved more than 50-percent improvement on their body as well. For both areas of the body, no serious treatment-related adverse events were reported, according to the company.
“These positive results reinforce the potential for ruxolitinib cream as a meaningful treatment option for people suffering from vitiligo, and we look forward to working with regulators to bring the first approved medical treatment that directly addresses repigmentation to patients in the U.S. and Europe,” says Jim Lee, MD, PhD and group vice president of Inflammation & Autoimmunity for Incyte. The company plans to submit the drug for FDA-approval for the treatment of vitiligo by the end of this year. Stay tuned to NewBeauty for updates!