Pooled Results from Incyte’s TRuE-AD1 and TRuE-AD2 Atopic Dermatitis Studies of Ruxolitinib Cream Show Clinically Meaningful Improvements in Patient-Reported Quality of Life Assessments

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:
	Ruxolitinib cream 0.75% BID	Ruxolitinib cream 1.5% BID	Vehicle
Primary endpoint
IGA-TS, responders	n=483	n=481	n=244
	44.7%*	52.6%*	11.5%
Key secondary endpoints
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