AAAAI: Twice-Daily Ruxolitinib Cream Improves Atopic Dermatitis Severity

Data from 3 large, randomized phase 3 studies presented at the American Academy of Allergy, Asthma, and Immunology (AAAAI)/World Allergy Organization (WAO) Joint Congress demonstrate that twice daily application of ruxolitinib cream (Opzelura; Incyte) monotherapy improved the management of atopic dermatitis (AD) in participants aged 2 years and older.¹

Atopic dermatitis is a highly pruritic chronic inflammatory skin condition | Image credit: Ladanifer | stock.adobe.com

AD is a highly pruritic chronic inflammatory skin condition. Ruxolitinib is a selective inhibitor of Janus kinase (JAK) 1 and JAK 2, enabling the suppression of cytokine signaling involved in the pathogenesis of AD. It is approved by the FDA for the short-term and non-continuous treatment of mild to moderate AD in patients who are not immunocompromised and are aged 12 years and older whose AD is not adequately controlled with other therapies.²

The studies presented at the AAAAI/WAO Joint Congress evaluated ruxolitinib cream in individuals aged 2 years and older with mild-to-moderate AD. Data presented at the meeting were from an 8-week comparative analysis of ruxolitinib cream’s efficacy and safety by age group.¹

The TRuE-AD3 study (NCT04921969) evaluated the treatment in children aged 2 to 11 (n = 330), the TRuE-AD1 study (NCT03745638) evaluated treatment in adolescents aged 12 to 17 (n = 236), and the TRuE-AD2 study (NCT03745651) evaluated its use in adults aged 18 years and older (n = 972). Participants had an Investigator’s Global Assessment (IGA) score of 2 or 3 and between 3% and 20% affected body surface area. They were randomized 2:2:1 to apply twice daily 0.75% ruxolitinib cream, 1.5% ruxolitinib cream, or vehicle cream for 8 weeks.¹

Efficacy was assessed as proportions of patients who achieved IGA treatment success, defined as a score of 0 or 1 with a 2-grade or better improvement from baseline, and 75% or 90% improvement from baseline in the Eczema Area and Severity Index (EASI-75, EASI-90) at week 8.¹

According to the study findings, at week 8, significantly more children, adolescents, and adults who applied 1.5% ruxolitinib cream versus vehicle achieved IGA treatment success (56.5% vs 10.8%, 50.6% vs 14%, and 53% vs 10.9%, respectively). Significantly more children, adolescents, and adults in the 1.5% ruxolitinib cream arm also achieved EASI-75 (67.2% vs 15.4%, 60.9% vs 34.9%, and 62.2% vs 16.4%, respectively) and EASI-90 (43.5% vs 10.8%, 39.1% vs 7%, and 44.9% vs 7%, respectively). Both strengths were well tolerated across all age groups, with few application site reactions and no safety findings suggestive of systemic JAK inhibition.¹

Ruxolitinib was originally approved by the FDA in September 2021, based on findings from TRuE-AD1 and TRuE-AD2. In the original data submitted to the FDA, significantly more patients treated with ruxolitinib cream achieved IGA treatment success at week 8, including 53.8% of participants in TRuE-AD1 and 51.3% in TRuE-AD2, compared to vehicle. Additionally, more patients treated with ruxolitinib experienced a clinically meaningful reduction in itch from baseline at week 8, as measured by a 4-point or greater reduction in the itch Numerical Rating Scale (itch NRS4).³

“Atopic dermatitis is a chronic immune-mediated disease that can be challenging to manage. Many patients do not respond well to existing treatments and have uncontrolled disease,” said Jonathan Silverberg, MD, PhD, MPH, an associate professor of dermatology and director of clinical research and contact dermatitis at the George Washington University School of Medicine and Health Sciences, in a news release following the initial FDA approval of ruxolitinib. “As a clinician, I am excited to have a nonsteroidal topical cream like [ruxolitinib].”³

REFERENCES

1. Simpson E, Eichenfield L, Papp K, et al. Efficacy and safety of ruxolitinib cream monotherapy in patients aged 2 years and older with mild-to-moderate atopic dermatitis: results from 3 large randomized phase 3 studies. Presented at: American Academy of Allergy, Asthma, and Immunology/World Allergy Organization Joint Congress 2025. San Diego, CA. March 2, 2025. Accessed February 26, 2025. https://www.jacionline.org/pb-assets/Health%20Advance/journals/ymai/AAAAI_2025_March2-1738868849127.pdf

2. Opzelura [package insert]. Incyte Corp; Updated July 2022. Accessed February 26, 2025. https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/215309s001lbl.pdf

3. Incyte announces US FDA approval of Opzelura (ruxolitinib) cream, a topical JAK inhibitor, for the treatment of atopic dermatitis (AD). News release. Incyte. September 21, 2021. Accessed February 26, 2025. https://investor.incyte.com/news-releases/news-release-details/incyte-announces-us-fda-approval-opzeluratm-ruxolitinib-cream