Ruxolitinib Cream Rapidly Reduced Itch for Atopic Dermatitis in Phase 3 Study

Recent study results demonstrated a noticeable reduction in itch just 12 hours after application of ruxolitinib.

Ruxolitinib cream 1.5% (Opzerula; Incyte) rapidly reduced itch in atopic dermatitis patients in 2 phase 3 trials. The study data showed ruxolitinib cream achieved improvements among adults and adolescents who had been diagnosed with atopic dermatitis (AD) for at least 2 years.1

The TRuE AD 1 and 2 trials were identical, phase 3, randomized, parallel, double-blind, vehicle-controlled studies where the cream was applied twice a day for 8 weeks to participants 12 years and older who had AD for at least 2 years and involved 3% to 20% of body surface area. Patients were randomized 2:2:1 to twice-daily 0.75% ruxolitinib cream, 1.5% ruxolitinib cream, or vehicle cream for 8 continuous weeks. The study enrolled 631 participants in TRuE AD 1 and 618 people participatedin TRuE AD 2.

Results show that in both studies, significantly more participants treated with ruxolitinib cream reached Investigator’s Global Assessment (IGA) Success at week 8 compared to the control group of vehicle-treated participants (0.75%) ruxolitinib cream (50.0%/39.0%) and 1.5% ruxolitinib cream (53.8%/51.3%) vsvehicle (15.1%/7.6%; P < .0001). A notable reduction in itch of –0.4 and –0.5 points wasidentified within 12 hours of the first application of both ruxolitinib cream treatment arms compared to the control group of vehicle-treated participants, who had a change of –0.1 points. Both treatment groups saw at least a 2-point itch reduction, measured by the Itch Numeric Rating Scale (NRS)2, as compared with 29.4% of the vehicle-treated group, according to a company press release announcing the data.

Ruxolitinib, a JAK1/JAK2 inhibitor, was approved by the US Food and Drug Administration in September 2021 for the treatment of mild to moderate atopic dermatitis. Around 16.5 million adults and 9.6 million children under the age 18 in the United States have AD. There is no cure for the skin disease and many patients have trouble controlling the symptoms. Not all medical, or non-medical treatments used to manage the disease are effective, and some can cause harmful side effects.2

 

References:

1. Papp K, Szepietowski JC, Kircik L, et al. Efficacy and safety of ruxolitinib cream for the treatment of atopic dermatitis: Results from 2 phase 3, randomized, double-blind studies. J Am Acad Dermatol. 2021 Oct;85(4):863-872. doi:10.1016/j.jaad.2021.04.

2.What is atopic dermatitis and how can I tell if I have it? National Eczema Association. Accessed September 26, 2022. https://nationaleczema.org