Study Finds Opzelura Used As-Needed Improves Quality of Life | AAD 2025

As-needed treatment with Opzelura (ruxolitinib) 1.5% cream was associated with long-term skin clearance and symptom control atopic dermatitis, reducing quality-of-life burdens for adolescents and adults, according to a study poster presented at the American Academy of Dermatology (AAD) Association annual meeting in Orlando, March 7, 2025, to March 11, 2025.

Researchers also discovered that the reduction in itch was the greatest contributor to quality-of-life improvement.

Developed by Incyte Corp., Opzelura was approved in September 2021 to treat mild to moderate atopic dermatitis (AD) in patients 12 and older who are not immunocompromised. It is also approved to treat nonsegmental vitiligo in patients 12 and older. Opzelura is a topical treatment that targets JAK1 and JAK2 proteins. JAK inhibitors work by targeting a central pathway in inflammation.

For the full year 2024, Opzelura generated revenue of $508 million, reflecting a 50% growth from 2023, according to a press release.

The wholesale acquisition cost of Opzelura is $2,094 per tube. Eligible patients with commercial coverage for Opzelura may pay as little as $0 per tube. Some patients whose coverage does not include the drug can pay $35 per prescription but must go to participating pharmacies.

Atopic dermatitis is a chronic skin condition that causes inflammation, itching and dryness, as well as significantly impacting a person’s quality of life. About 7.3% of adults and 15% of children in the United States have atopic dermatitis, according to the Allergy & Asthma Network.

Data from the pivotal TRuE-AD1 and TRuE-AD2 phase 3 studies demonstrated that Opzelura twice a day for eight weeks was efficacious and well-tolerated in patients.

Researchers, led by Leon Kircik, M.D., an associate clinical professor at the Icahn School of Medicine at Mount Sinai in New York, wanted to examine long-term durability of high-threshold disease control in multiple disease domains following application of 1.5% Opzelura cream in patients with atopic dermatitis who participated in the TRuE-AD1 and TRuE-AD2 studies.

For this study, 428 eligible patients who participated in TRuE-AD1 and TRuE-AD2 were included in the long-term portion of the study. They were randomly assigned to receive Opzelura.75 or 1.5% twice a day for eight weeks and then assigned randomly either to continue with this treatment regimen or to use Opzelura as needed for 44 weeks. Disease control was assessed by the proportion of patients achieving clear or almost clear skin, no itch, and no nights of disturbed sleep.

At week eight, 32.7% of patients had achieved no itch, 71.8% had achieved no disturbed sleep, and 67.1 had clear or almost clear skin. Additionally, 27.3% of patients had achieved all three responses. Of the 107 patients with no itch, no disturbed sleep or clear or almost clear skin at week 52, 93.5% had a quality of life not affected by atopic dermatitis, and the elimination of itch was the driver in the better quality of life.