Incyte announced positive topline results from the TRuE-AD clinical trial program (TRuE-AD1 and TRuE-AD2) of ruxolitinib cream for the treatment of atopic dermatitis in patients aged 12 years and older.

TRuE-AD1 and TRuE-AD2 are phase 3, double-blind, randomized, vehicle-controlled studies that evaluated the efficacy and safety of ruxolitinib cream, a Janus kinase (JAK) inhibitor, in 1250 patients aged ≥12 years with atopic dermatitis. Patients were randomized 2:2:1 to receive ruxolitinib cream (0.75% or 1.5%) twice daily or vehicle cream (non-medicated) for 8 weeks. 

The primary end point for both trials was the proportion of patients achieving an Investigator’s Global Assessment Treatment Success (IGA-TS), defined as a score of 0 (clear) or 1 (almost clear). Key secondary end points included the proportion of patients with ≥75% improvement from baseline in the Eczema Area and Severity Index (EASI75) score and a ≥4-point improvement in Itch Numerical Rating Scale (NRS4) score at week 8.

Findings from TRuE-AD1 showed that 50% of patients treated with ruxolitinib cream 0.75% and 53.8% of patients treated with ruxolitinib cream 1.5% achieved IGA-TS compared with 15.1% treated with vehicle control (P <.0001 for both). Additionally, 56% of patients treated with ruxolitinib cream 0.75% and 62.1% of patients treated with ruxolitinib cream 1.5% achieved EASI75 compared with 24.6% treated with vehicle control (P <.0001 for both).

In TRuE-AD2, the primary end point was achieved by 39% of patients treated with ruxolitinib cream 0.75% and 51.3% of patients treated with ruxolitinib cream 1.5% compared with 7.6% treated with vehicle control (P <.0001 for both). Moreover, 51.5% of patients treated with ruxolitinib cream 0.75% and 61.8% of patients treated with ruxolitinib cream 1.5% achieved EASI75 compared with 14.4% treated with vehicle control (P <.0001 for both).

Both studies demonstrated a statistically significant difference in itch reduction as measured by the NRS4 for ruxolitinib cream (0.75% and 1.5%) compared with vehicle control. Full data from both studies will be submitted for publication and presentation at an upcoming scientific meeting.

The safety profile of ruxolitinib cream was consistent with previous studies. The Company plans to offer a 44-week long-term safety extension period to patients who have successfully completed the 8-week study.

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“The successful outcomes of both the TRuE-AD1 and TRuE-AD2 studies confirm the potential of ruxolitinib cream as an important, nonsteroidal treatment option for the millions of patients suffering from AD,” said Jim Lee, MD, Group Vice President, Inflammation & AutoImmunity, Incyte. “We look forward to working with regulators as we seek approval of ruxolitinib cream as the first topical formulation of a JAK inhibitor for patients with AD.”

Ruxolitinib is currently available in an oral tablet formulation for the treatment of myelofibrosis (MF), polycythemia vera, and steroid-refractory acute graft-versus-host disease.

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For more information visit incyte.com.

This article originally appeared on MPR