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- Results reinforce that ruxolitinib cream treatment results in a rapid, substantial and sustained reduction in itch - Results also demonstrate improvement in patient-reported perceptions of sleep quality, sleep depth and restoration associated with sleep as measured by the PROMIS® Short Form-Sleep Disturbance (8b) questionnaire - Oral presentation will be available on-demand as part of the 29th EADV Virtual Congress
WILMINGTON, Del.--(BUSINESS WIRE)-- Incyte (Nasdaq:INCY) today announced efficacy and safety results from a pooled analysis of two randomized, double-blind, vehicle-controlled Phase 3 studies – TRuE-AD1 and TRuE-AD2 – evaluating ruxolitinib cream for the treatment of patients with mild-to-moderate atopic dermatitis (AD). The presentation (FC08.08) will be available on-demand as part of the 29th European Academy of Dermatology and Venereology (EADV) Congress, held virtually from October 29-31, 2020.
Key findings from the individual TRuE-AD1 and TRuE-AD2 studies were previously reported.
The new, pooled data reinforce that treatment with ruxolitinib cream resulted in a rapid, substantial and sustained reduction in itch; and improved the extent and severity of AD as measured by the Eczema Area Severity Index (EASI) and Scoring Atopic Dermatitis (SCORAD) assessment tools.
In addition, treatment with ruxolitinib cream resulted in notable improvements in quality of life measures such as the PROMIS (Patient-Reported Outcomes Measurement Information System)1 sleep disturbance (8b)2 score. PROMIS is a set of well-accepted patient-reported outcome measurement tools that are psychometrically supported.1 In the TRuE-AD trials, the PROMIS Short Form-Sleep Disturbance (8b) questionnaire was used to assess patients’ self-reported perceptions of sleep quality, sleep depth and restoration associated with sleep.
Key results from the pooled analysis include: |
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Ruxolitinib cream 0.75% BID |
Ruxolitinib cream 1.5% BID |
Vehicle |
Primary endpoint |
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IGA-TS, responders |
n=483 |
n=481 |
n=244 |
44.7%* |
52.6%* |
11.5% |
|
Key secondary endpoints |
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EASI-75, responders |
n=483 |
n=481 |
n=244 |
53.8%* |
62.0%* |
19.7% |
|
Itch NRS (≥4-point improvement)†, responders |
n=313 |
n=307 |
n=158 |
41.5%* |
51.5%* |
15.8% |
|
PROMIS Short Form-Sleep Disturbance (8b) (≥6-point improvement)‡, responders |
n=446 |
n=449 |
n=226 |
20.9%** |
23.8%** |
14.2% |
|
Secondary endpoint |
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SCORAD, mean change from baseline |
n=483 |
n=481 |
n=244 |
-62.9%* |
-67.3%* |
-30.4% |
|
Additional efficacy analysis |
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Daily Itch NRS Score, mean change from baseline within 12 hours |
n=483 |
n=481 |
n=244 |
-0.4*** |
-0.5*** |
-0.1 |
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IGA-TS: Investigator’s Global Assessment (IGA)-Treatment Success defined as an IGA score of 0 (clear) or 1 (almost clear) with ≥2-point improvement from baseline at Week8; BID: twice daily; EASI-75: ≥75% improvement from baseline at Week 8 in the Eczema Area and Severity Index (EASI) score; NRS: Numerical Rating Scale; PROMIS: Patient-Reported Outcomes Measurement Information System; SCORAD: Scoring Atopic Dermatitis. †Patients included in the analysis had an Itch NRS score ≥4 at baseline; ‡Patients included in the analysis had a PROMIS Short Form-Sleep Disturbance (8b) score of ≥6 at baseline. *P | |||
