- Ruxolitinib cream resulted in a rapid and robust clinical response, with significantly more patients achieving Investigator’s Global Assessment (IGA) Treatment Success (IGA-TS; primary endpoint), defined as an IGA score of 0 (clear) or 1 (almost clear), and EASI75 (key secondary endpoint), defined as the proportion of patients who achieved a ≥ 75% improvement in the Eczema Area and Severity Index Score
- Treatment with ruxolitinib cream also resulted in a rapid, substantial and sustained reduction in itch, a key quality of life measure for patients with atopic dermatitis
- Data support the planned submission of a New Drug Application (NDA) to the
“Data that will be presented today 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
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
These data will be presented as part of the Revolutionizing Atopic Dermatitis Virtual Symposium during the Late Breaking Abstracts session on
About Atopic Dermatitis
Atopic dermatitis (AD) is a common chronic disease characterized by inflammation of the skin. At least 11 million people in
The TRuE-AD clinical trial program consists of two randomized, double-blind, dose-ranging, vehicle-controlled Phase 3 studies, TRuE-AD1 (NCT03745638) and TRuE-AD2 (NCT03745651), 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.
The primary endpoint of the TRuE-AD studies was the proportion of participants achieving an Investigator’s Global Assessment Treatment Success (IGA-TS), defined as an IGA score of 0 (clear) or 1 (almost clear) with at least a 2-point improvement from baseline at Week 8. Key secondary endpoints include: the proportion of patients achieving at least a 75% improvement from baseline in the Eczema Area and Severity Index (EASI75) score – another measurement of the extent and severity of AD, and the proportion of participants with at least a four-point improvement in the itch numerical rating scale (NRS4). The studies have also been tracking the frequency, duration and severity of adverse events associated with the use of ruxolitinib cream.
About Ruxolitinib Cream
Ruxolitinib cream is a proprietary formulation of Incyte’s selective JAK1/JAK2 inhibitor ruxolitinib that has been designed for topical application. Ruxolitinib cream is currently in Phase 3 development for the treatment of patients with mild-to-moderate atopic dermatitis (TRuE-AD) and for the treatment of adolescents and adults with vitiligo (TRuE-V).
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Except for the historical information set forth herein, the matters set forth in this press release, including statements regarding the presentation of data from the Company’s ongoing clinical development program for ruxolitinib cream, whether and when the Company will file an NDA for ruxolitinib cream, and whether ruxolitinib cream will be approved for use in the
These forward-looking statements are based on the Company’s current expectations and subject to risks and uncertainties that may cause actual results to differ materially, including unanticipated developments in and risks related to: unanticipated delays; further research and development and the results of clinical trials possibly being unsuccessful or insufficient to meet applicable regulatory standards or warrant continued development; the ability to enroll sufficient numbers of subjects in clinical trials; determinations made by the FDA; the Company’s dependence on its relationships with its collaboration partners; the efficacy or safety of the Company’s products and the products of the Company’s collaboration partners; the acceptance of the Company’s products and the products of the Company’s collaboration partners in the marketplace; market competition; sales, marketing, manufacturing and distribution requirements; greater than expected expenses; expenses relating to litigation or strategic activities; and other risks detailed from time to time in the Company’s reports filed with the
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