Date: 08-Apr-2020

Incyte Presents Phase 3 Data From TRuE-AD Programme Of Ruxolitinib To Treat Atopic Dermatitis At RAD Virtual Symposium

ncyte, a global biopharmaceutical company, announced the first presentation of phase 3 data for ruxolitinib cream in atopic dermatitis at the Revolutionizing Atopic Dermatitis (RAD) Virtual Symposium. The phase 3 TRuE-AD programme, which includes the TRuE-AD1 and TRuE-AD2 studies, is evaluating ruxolitinib cream 0.75% and 1.5% twice daily (BID) for the treatment of patients with mild-to-moderate atopic dermatitis.

“Data that will be presented during the Revolutionizing Atopic Dermatitis Virtual Symposium show that ruxolitinib cream significantly reduced both the skin inflammation and itch associated with atopic dermatitis. The reduction in itch can potentially improve key disease-related and quality of life outcomes for patients living with atopic dermatitis,” said Jim Lee, M.D., Ph.D., Group vice president, Inflammation & AutoImmunity, Incyte. “We are pleased to share these important data with the dermatology community, as they support the potential of ruxolitinib cream to become an important antipruritic and anti-inflammatory treatment option for patients with atopic dermatitis, and we look forward to submitting a New Drug Application (NDA) to the US Food and Drug Administration later this year.”

The primary endpoint for the TRuE-AD1 and TRuE-AD2 studies was the proportion of patients achieving Investigator’s Global Assessment (IGA) Treatment Success (IGA-TS), defined as an IGA score of 0 (clear) or 1 (almost clear) with at least a two-point improvement from baseline, at Week 8. Key secondary endpoints included the proportion of patients who achieved a = 75% improvement in Eczema Area and Severity Index (EASI75) score at Week 8 and the proportion of patients with a = 4-point improvement in Itch Numerical Rating Scale (NRS4) score at Week 8.

As previously reported, both phase 3 studies met the primary endpoint. Significantly more patients treated with ruxolitinib cream 0.75% BID [TRuE-AD1: 50.0%; TRuE-AD2: 39.0%] and 1.5% BID [TRuE-AD1: 53.8%; TRuE-AD2: 51.3%] achieved IGA-TS compared to vehicle [non-medicated cream; TRuE-AD1: 15.1%; TRuE-AD2: 7.6%]; P < 0.0001. Additionally, a significant proportion of patients treated with ruxolitinib cream 0.75% BID [TRuE-AD1: 56.0%; TRuE-AD2: 51.5%] and 1.5% BID [TRuE-AD1: 62.1% and TRuE-AD2: 61.8%] achieved EASI75 at Week 8 compared to vehicle [TRuE-AD1: 24.6%; TRuE-AD2: 14.4%]; P < 0.0001.

Data from both studies also demonstrate that treatment with ruxolitinib cream has a rapid, substantial and sustained impact on itch, a key quality of life measure for patients living with atopic dermatitis: Significantly more patients treated with ruxolitinib cream experienced a clinically meaningful reduction in itch (NRS4) than patients given vehicle at Week 8.

In TRuE-AD1, 40.4% of patients treated with ruxolitinib cream 0.75% BID and 52.2% of patients treated with ruxolitinib cream 1.5% BID achieved NRS4, compared to 15.4% of patients given vehicle (P < 0.001 and P < 0.0001, respectively).

In TRuE-AD2, 42.7% of patients treated with ruxolitinib cream 0.75% BID and 50.7% of patients treated with ruxolitinib cream 1.5% BID achieved NRS4, compared to 16.3% of patients given vehicle (P < 0.0001).

A rapid reduction in itch was observed with ruxolitinib cream treatment. A significantly greater reduction in the itch Numerical Rating Scale (NRS) was observed within 12 hours of treatment with ruxolitinib cream 1.5% BID compared to vehicle (P < 0.05).

The overall safety profile of ruxolitinib cream in atopic dermatitis was consistent with previous study data, with no new safety signals observed. The long-term safety of ruxolitinib cream is currently being evaluated in the 44-week extension period of both studies.

“Atopic dermatitis can have a profound impact on patients and their quality of life. I see a need for more treatment options that can improve itch and other symptoms that can lead to disruption in activities of daily living,” said Kim Papp, M.D., Ph.D., founder and president of Probity Medical Research and the Coordinating Investigator for the TRuE-AD program. “I am encouraged by these data. The potential of ruxolitinib cream to become an important treatment option for patients living with atopic dermatitis is exciting.”

Atopic dermatitis (AD) is a common chronic disease characterized by inflammation of the skin. At least 11 million people in the United States have been diagnosed with and are being treated for AD. The majority of these patients have a mild or moderate form of the disease and approximately 80% are adults or adolescents. Signs and symptoms of AD include irritated and itchy skin that can cause red lesions that may ooze and crust. Patients with AD are also more susceptible to bacterial, viral and fungal infections.

The TRuE-AD clinical trial program consists of two randomized, double-blind, dose-ranging, vehicle-controlled phase 3 studies, TRuE-AD1 and TRuE-AD2, evaluating the safety and efficacy of ruxolitinib cream compared to vehicle (non-medicated cream) in patients with atopic dermatitis (AD). Both studies enrolled more than 600 patients (age = 12 years) diagnosed with AD for at least two years and who were candidates for topical therapy.

Patients with an Investigator’s Global Assessment (IGA) score of 2 to 3, and with AD on 3% to 20% of their Body Surface Area (BSA) (excluding scalp) were randomized 2:2:1 into one of three treatment arms for eight weeks, including: ruxolitinib cream 0.75% administered twice daily (BID); ruxolitinib cream 1.5% BID; and vehicle (non-medicated cream). Participants who successfully completed an assessment at Week 8 were offered participation in the 44-week long-term safety treatment extension period with ruxolitinib cream 0.75% or 1.5% BID.