Ruxolitinib Cream Provides Substantial, Sustained Itch Relief in AD Patients

Ruxolitinib cream is efficacious in providing rapid, substantial, and sustained improvements in itch in adults with atopic dermatitis and chronic itch, according to a poster presented at the Revolutionizing Atopic Dermatitis (RAD) conference in Washington, DC.¹ Itch reduction was detected in as few as 15 minutes following topical application.

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Researchers sought to determine the short-term clinical benefits of the drug in adult patients with atopic dermatitis, specifically with regard to pruritus and disease severity. They cited 2 prior trials (TRuE-AD1 and TruE-AD2), both of which were phase 3 trials involving adolescent and adult patients with atopic dermatitis. The trials demonstrated significant improvement in itch in patients treated with 1.5% ruxolitinib cream as opposed to a vehicle treatment.

The single-site study involved adult patients ages 18 to 65 years who met the following criteria:

• 1% to 20% affected body surface area (excluding some parts of the body, such as folds, genitals, palms, scalp, or soles)
• Atopic dermatitis for greater than 6 months
• Chronic itch related to atopic dermatitis for equal to or greater than 3 months
• Investigator’s Global Assessment (IGA) score equal to or greater than 2
• Peak pruritus numerical rating scale (PP-NRS) score equal to or greater than 4

Prospective participants were excluded from participation if they had an unstable course of disease, had used antibiotics within 2 weeks of the start of the run-in period, or other skin conditions that could potentially interfere with study results, to name a few.

Participants were asked to record their PP-NRS scores on a daily basis through day –1 and day 2 through day 29 using an electronic diary. Researchers instructed participants to apply a topical 1.5% ruxolitinib cream on a twice-daily basis at roughly 12 hours apart. Patients had been instructed to apply the cream to all lesions identified as atopic dermatitis at baseline and to any new lesions.

Throughout the duration of the study, researchers evaluated several disease-specific factors, including transepidermal water loss (TEWL) on days 1 and 29 and modified PP-NRS (mPP-NRS) on day 1 at 15 minutes, 30 minutes, 1 hour, 2 hours, 4 hours, and 6 hours post drug application. Researchers also collected IGA data on days 1, 8, 15, and 29.

Researchers had found that the average change in baseline in PP-NRS on day 2 was -3.4. Through day 29, the average PP-NRS change from baseline continued to increase, ultimately to –5.7. Skin treated with ruxolitinib cream experienced a substantial decrease in TEWL from baseline.

With respect to safety endpoints, researchers noted that 15 of 49 participants, or 30.6%, experienced treatment-emergent adverse events. However, none of these were serious in nature, and none led to participants exiting the study. The most common of these were COVID-19, back pain, headache, nasopharyngitis, and upper respiratory tract infection.

“Participants with AD [atopic dermatitis] applying 1.5% ruxolitinib cream in this study experienced rapid, substantial improvement in itch, which was sustained and further improved through 28 days of treatment,” study authors wrote. “Itch reduction was observed as early as 15 minutes after firstruxolitinib cream application, and peak reduction was observed at 4 hours after first application. These results are consistent with the established data on ruxolitinib cream as an effective, well-tolerated topical treatment for AD.”

Reference

1. Bissonnette R, Ren H, Nawaz H, Halden P, Saint-Cyr Proulx E. Rapid, substantial, and sustained reduction of itch in adults with atopic dermatitis applying ruxolitinib cream. Poster presented at the 2023 Revolutionizing Atopic Dermatitis Conference; April 29-May 1, 2023; Washington, DC. https://djbpnesxepydt.cloudfront.net/radv/April2023/April-2023-Posters/396_Poster_Ruxolitinib_SCRATCH-AD_Bissonnette-et-al_1682462290487.pdf