Opzelura Eczema Cream Gets FDA Approval


Despite many treatment options for atopic dermatitis, the most common form of eczema, many people continue to struggle with symptoms such as inflammation, bumps, rashes, and dry, itchy, and patches of skin. scaly.

These patients have a new option: On September 21, the United States Food and Drug Administration (FDA) approved Opzelura (ruxolitinib), a cream for the treatment of mild to moderate atopic dermatitis in patients aged 12 and older. more who cannot use other topical treatments. or not getting enough symptom relief from other therapies.

Opzelura belongs to a class of medicines called JAK (Janus kinase) inhibitors. It is the first JAK inhibitor – oral or topical – to be approved by the FDA for eczema.

Because Opzelura works differently from other treatments for atopic dermatitis, it may help some people who have not had success with other therapies, doctors say.

“A lot of people don’t respond well to current treatments or lose response to treatment over time, and as a result tend to skip therapy,” says Amy Spizuoco, DO, associate clinical instructor of dermatology at medical school. Icahn of Mount Sinai in New York City. “This highlights the need for new treatment options.”

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How does Opzelura work?

A clinical trial used as the basis for FDA approval found that 53.8% of adolescents and adults with atopic dermatitis who used Opzelura had fair skin after eight weeks, compared with 15.1% of those who used opzelura. non-drug 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 near-fair skin after eight weeks of treatment with Opzelura, compared to 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 to around 15-16% of those taking placebo.

Common side effects that occurred in over 1% of trial participants included diarrhea, bronchitis, ear infections, tonsillitis, and the common cold.

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, assistant professor of dermatology at the University of Pennsylvania Perelman School of Medicine in Philadelphia Cream. Other topical eczema treatments can have side effects such as burns and skin irritation, says Dr. Fuxench.

These side effects can be particularly troubling when patients experience flare-ups of eczema on sensitive parts of their body such as the face, armpits, genitals, or groin. “In such cases, Opzelura may be a reasonable option,” says Fuxench.

How do JAK inhibitors work?

According to the National Eczema Society, researchers believe 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 shutting down certain overactive pathways within cells, JAK inhibitors limit cytokines that can trigger certain symptoms of eczema.

The FDA has previously approved oral JAK inhibitors to treat 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 drugs with the most dangerous potential side effects, based on the risk of serious infections, cancer, events such as 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, dermatologist and clinical associate professor at the University of Sydney in Australia.

“There have been significant concerns regarding oral Janus kinase inhibitors, which led to the black box warning placed on topical Opzelura,” he explains.

Topical JAK inhibitors are expected to have a lower risk of serious side effects because, unlike pills that send drugs throughout the body, creams and ointments only apply treatment to a targeted area of ​​the skin, explains Thomas Bieber, MD, PhD, professor and chair of dermatology and allergy at University Hospital Bonn, Germany.

Still, the black box warning may make some doctors and patients reluctant to try Opzelura. “There will be some caution first as this drug is the first of its kind, and further studies may be needed to better assess its efficacy, safety and tolerability with long-term use,” says Fuxench of the ‘University of Pennsylvania.

RELATED: New safety warnings on JAK inhibitors, used to treat arthritis and other inflammatory conditions

More JAK eczema inhibitors are on the horizon

Cibinqo (abrocitinib), an oral JAK inhibitor from drug maker Pfizer, received marketing approval from drug regulatory authorities in the UK 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 concerns seen with another JAK inhibitor, Xeljanz (tofacitinib), the company said.

JAK Olumiant’s oral inhibitor (baricitinib) is approved for atopic dermatitis in Europe and Japan and for rheumatoid arthritis in the United States, drugmaker Eli Lilly reported in April 2021.

JAK Rinvoq oral inhibitor (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 gain more information on the “benefit-risk profile,” drugmaker AbbVie said.

“Topical JAK inhibitors offer the possibility of managing milder disease without the same potential side effects of oral therapies,” explains Dr. Smith.

But when topical therapy doesn’t achieve desired results on its own, he adds, some patients may benefit from a combination of topical and oral treatments.

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