These patients have a new option: On September 21, the U.S. Food and Drug Administration (FDA) approved Opzelura (ruxolitinib), a cream for treating mild to moderate atopic dermatitis in patients age 12 years and older who can’t use other topical treatments or don’t get enough symptom relief from other therapies. Opzelura belongs to a class of drugs called JAK (Janus kinase) inhibitors. It is the first JAK inhibitor — either oral or topical — to be FDA-approved for eczema. Because Opzelura works differently than other treatments for atopic dermatitis, it may help some people who haven’t had success with other therapies, doctors say. “Many people do not respond well to current treatments or lose treatment response over time, and as a result tend to cycle through therapies,” says Amy Spizuoco, DO, an associate clinical instructor of dermatology at the Icahn School of Medicine at Mount Sinai in New York City. “This underscores the need for new treatment options.” RELATED: Eczema Treatment: Topical Medication, Light Therapy, Natural Remedies, and More
How Well Does Opzelura Work?
A clinical trial used as the basis for FDA approval found that 53.8 percent of the teens and adults with atopic dermatitis who used Opzelura had clear skin after eight weeks, compared with 15.1 percent of those who used a nonmedicated placebo cream, according to results announced by Incyte, the company that makes the drug. A second trial found that 51.3 percent of participants had nearly clear skin after eight weeks of treatment with Opzelura, compared with 7.6 percent of those on placebo. In addition, these clinical trials found that itching was reduced in more than half of patients using Opzelura, compared with about 15 to 16 percent of those on placebo. Common side effects that occurred in more than 1 percent of trial participants included diarrhea, bronchitis, ear infections, tonsillitis, and common colds.
Opzelura vs. Other Eczema Creams and Ointments
With topical corticosteroids, a common approach to treating eczema, side effects can include thinning of the skin, stretch marks, discoloration, and bruising, says Zelma Chiesa Fuxench, MD, an assistant professor of dermatology at the University of Pennsylvania Perelman School of Medicine in Philadelphia. Other topical eczema treatments can have side effects such as burning and skin irritation, Dr. Fuxench says. These side effects may be particularly troubling when patients have eczema flares on sensitive parts of their body such as the face, underarms, genitals, or groin. “In such cases, Opzelura may be a reasonable option,” Fuxench says.
How Do JAK Inhibitors Work?
According to the National Eczema Society, researchers believe that eczema may be caused in part by an increase in cytokines — immune system messengers in the blood and skin that are linked to inflammation. By closing off certain overactive pathways within cells, JAK inhibitors limit the cytokines that may trigger certain eczema symptoms. The FDA has already approved oral JAK inhibitors to treat the autoimmune diseases rheumatoid arthritis, psoriatic arthritis, and ulcerative colitis.
Why Does Opzelura Have a ‘Black Box’ Warning?
Along with its approval of Opzelura, the FDA issued a so-called “black box” warning — reserved for medications with the most dangerous potential side effects, based on the risk of serious infections, cancer, events like heart attack and stroke, and death. These risks were not seen in clinical trials of Opzelura, but only in trials of oral JAK inhibitors in patients with rheumatoid arthritis, says Saxon Smith, MBChB, PhD, a dermatologist and clinical associate professor at the University of Sydney in Australia. “There have been significant concerns relating to oral Janus kinase inhibitors, leading to the black box warning placed on topical Opzelura,” he explains. Topical JAK inhibitors should have a lower risk of serious side effects because, unlike pills that send medication throughout the body, creams and ointments apply therapy only to a targeted area on the skin, says Thomas Bieber, MD, PhD, a professor and the chair of dermatology and allergy at the University Hospital of Bonn in Germany. Still, the black box warning may make some doctors and patients reluctant to try Opzelura. “There will be some measure of caution at first as this medication is a first of its kind, and more studies may be needed to better assess its efficacy, safety, and tolerability with long-term use,” says the University of Pennsylvania’s Fuxench. RELATED: New Safety Warnings on JAK Inhibitors, Used to Treat Arthritis and Other Inflammatory Conditions
More JAK Inhibitors for Eczema Are on the Horizon
Cibinqo (abrocitinib), an oral JAK inhibitor from the drugmaker Pfizer, won marketing approval from drug regulators in the United Kingdom in September 2021, according to a press release shared on Business Wire. The FDA extended its review of the drug in July 2021 in light of rheumatoid arthritis safety issues seen with another JAK inhibitor, Xeljanz (tofacitinib), the company said. The oral JAK inhibitor Olumiant (baricitinib) is approved for atopic dermatitis in Europe and Japan and for rheumatoid arthritis in the United States, the drugmaker Eli Lilly reported in April 2021. The oral JAK inhibitor Rinvoq (upadacitinib) is approved for atopic dermatitis in Europe and rheumatoid arthritis in the United States. In April 2021 the FDA extended its review of Rinvoq for atopic dermatitis to get more information on the “benefit-risk profile,” drugmaker AbbVie said. “Topical JAK inhibitors provide the opportunity to manage more mild disease without the same potential side effects from oral therapies,” Dr. Smith says. But when a topical therapy isn’t getting desired results on its own, he adds, some patients may benefit from receiving a combination of topical and oral treatments.
