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%Start  Eczema Cream Opzelura Gets FDA Approval Everyday Health MenuNewslettersSearch Eczema <h1>FDA Approves a First-of-Its-Kind Eczema Cream Opzelura Ruxolitinib </h1> The medication, which belongs to a class of drugs called JAK inhibitors, may help people with mild or moderate atopic dermatitis who aren’t getting enough symptom relief from other treatments. By Lisa RapaportMedically Reviewed by Ross Radusky, MDReviewed: October 18, 2021Medically ReviewedIn clinical trials, about half of teens and adults using Opzelura had clear skin after eight weeks.Marti Sans/StocksyDespite numerous treatment options for atopic dermatitis, the most common form of eczema, many people continue to struggle with symptoms like inflammation, bumps, rashes, and dry, itchy, and scaly patches of skin.
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%Start  Eczema Cream Opzelura Gets FDA Approval Everyday Health MenuNewslettersSearch Eczema

FDA Approves a First-of-Its-Kind Eczema Cream Opzelura Ruxolitinib

The medication, which belongs to a class of drugs called JAK inhibitors, may help people with mild or moderate atopic dermatitis who aren’t getting enough symptom relief from other treatments. By Lisa RapaportMedically Reviewed by Ross Radusky, MDReviewed: October 18, 2021Medically ReviewedIn clinical trials, about half of teens and adults using Opzelura had clear skin after eight weeks.Marti Sans/StocksyDespite numerous treatment options for atopic dermatitis, the most common form of eczema, many people continue to struggle with symptoms like inflammation, bumps, rashes, and dry, itchy, and scaly patches of skin.
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Mason Rodriguez 2 minutes ago
These patients have a new option: On September 21, the U.S. Food and Drug Administration (FDA) appr...
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Lucas Martinez 1 minutes ago
It is the first JAK inhibitor — either oral or topical — to be FDA-approved for eczema. Because ...
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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.
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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.
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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.
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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.
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Common side effects that occurred in more than 1 percent of trial participants included diarrhea, br...
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“This underscores the need for new treatment options.” RELATED: Eczema Treatment: Topical Medication, Light Therapy, Natural Remedies, and More  <h2>How Well Does Opzelura Work </h2> 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.
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“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.
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Common side effects that occurred in more than 1 percent of trial participants included diarrhea, br...
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Other topical eczema treatments can have side effects such as burning and skin irritation, Dr. Fuxen...
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Common side effects that occurred in more than 1 percent of trial participants included diarrhea, bronchitis, ear infections, tonsillitis, and common colds. <h2>Opzelura vs Other Eczema Creams and Ointments</h2> 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.
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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.
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Other topical eczema treatments can have side effects such as burning and skin irritation, Dr. Fuxen...
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These side effects may be particularly troubling when patients have eczema flares on sensitive parts...
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Other topical eczema treatments can have side effects such as burning and skin irritation, Dr. Fuxench says.
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Other topical eczema treatments can have side effects such as burning and skin irritation, Dr. Fuxench says.
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These side effects may be particularly troubling when patients have eczema flares on sensitive parts...
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By closing off certain overactive pathways within cells, JAK inhibitors limit the cytokines that may...
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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. <h2>How Do JAK Inhibitors Work </h2> 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.
Mia Anderson Member
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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.
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By closing off certain overactive pathways within cells, JAK inhibitors limit the cytokines that may...
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Why Does Opzelura Have a Black Box Warning

Along with its approval of Opzelura, the FDA ...
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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.
Victoria Lopez Member
access_time 40 minutes ago
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.
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Why Does Opzelura Have a Black Box Warning

Along with its approval of Opzelura, the FDA ...
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<h2>Why Does Opzelura Have a Black Box Warning </h2> 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.
Brandon Kumar Member
access_time 27 minutes ago

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.
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“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.
Harper Kim Member
access_time 40 minutes ago
“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.
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Still, the black box warning may make some doctors and patients reluctant to try Opzelura. “There ...
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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.
Sophia Chen Member
access_time 55 minutes ago
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.
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The oral JAK inhibitor Rinvoq (upadacitinib) is approved for atopic dermatitis in Europe and rheumat...
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RELATED: New Safety Warnings on JAK Inhibitors, Used to Treat Arthritis and Other Inflammatory Conditions <h2>More JAK Inhibitors for Eczema Are on the Horizon</h2> 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.
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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.
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The oral JAK inhibitor Rinvoq (upadacitinib) is approved for atopic dermatitis in Europe and rheumat...
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Smith says. But when a topical therapy isn’t getting desired results on its own, he adds, some pat...
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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.
Grace Liu Member
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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.
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Smith says. But when a topical therapy isn’t getting desired results on its own, he adds, some pat...
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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.
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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.
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 Eczema Cream Opzelura Gets FDA Approval Everyday Health MenuNewslettersSearch Eczema

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