Ruxolitinib Cream FDA Approved for Atopic Dermatitis


The FDA approved the topical JAK1/JAK2 inhibitor ruxolitinib for the treatment of mild to moderate atopic dermatitis in September 2021.

Ruxolitinib cream 1.5% (Opzelura; Incyte) is a first-in-class topical JAK inhibitor for short term and noncontinuous chronic treatment of mild to moderate atopic dermatitis (AD), which targets the key cytokines believed to contribute to itch and inflammation and offers a newer option for patients whose AD is uncontrolled.

In a non-continuing medical education presentation that was sponsored by Incyte and presented at the Winter Clinical Dermatology Conference this week in Kauai, Hawaii, Alexandra K. Golant, MD, who is medical director of the Dermatology Faculty Practice at the Icahn School of Medicine at Mount Sinai, explained ruxolitinib cream’s role in treating AD. This was a particularly timely talk since the FDA recently approved this product for AD.1

She presented findings from Incyte’s TRuE-AD clinical trial program, which evaluated the topical in over 1,200 patients, ages 12 years and older, who had been diagnosed with AD for at least 2 years and were also candidates for topical therapy. The NDA filing also included safety and efficacy data from a supplemental 44-week, open-label, long-term extension study of both TRuE-AD1 (NCT03745638) and TRuE-AD2 (NCT03745651).

As previously reported by Dermatology Times®, results of TRuE-AD1 showed 50% of the ruxolitinib cream 0.75% group and 53.8% of the ruxolitinib cream 1.5% group achieved the primary end point compared to 15.1% vehicle. Moreover, 56% of the ruxolitinib cream 0.75% group and 62.1% of the ruxolitinib cream 1.5% group achieved the secondary end point of 75% improvement or more in Eczema Area and Severity Index (EASI) score compared to baseline vs 24.6% vehicle.

In TRuE-AD2, 39% of patients treated with ruxolitinib cream 0.75% and 51.3% treated with 1.5% met the primary end point compared to 7.6% of the vehicle group. Also, more than 51% of patients in the 0.75% group and 61.8% of patients in the 1.5% group achieved 75% improvement or more in the EASI score from baseline, vs 14.4% vehicle, according to a press release announcing the study’s results.2

Once the approval was announced, in the release, officials with Incyte advised physicians to educate themselves about important safety information regarding ruxolitinib, including a recently issued boxed warning from the FDA for serious infections, mortality, malignancy, major adverse cardiovascular events, and thrombosis, seen with JAK inhibitors for inflammatory conditions.

Fielding a question from an audience member about discussing these warnings with patients, Golant advised the dermatologists in attendance to “be upfront about it,” and advise the patients: “you are going to see a boxed warning when you get this from the pharmacy, and this largely comes from not an AD population,” she said. “I do try to talk to them about the indication I’m prescribing it for, on a limited body surface area in a little period of time.” She said she also discusses the risks of their use as topicals rather than systemic.

This article was originally published on Dermatology Times.


  1. Golant AK. Atopic dermatitis: the burden of disease and a novel topical pathway. Presented at: 2022 Winter Clinical Dermatology Conference; January 14 to 19, 2022; Kauai, Hawaii.
  2. Incyte announces acceptance and priority review of nda for ruxolitinib cream for atopic dermatitis. Incyte. Press release. Published February 19, 2021. Accessed March 12, 2021.
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