Incyte Announces Positive Data from Phase 2b Trial of Ruxolitinib Cream in Patients with Atopic Dermatitis
- Study met primary and key secondary endpoints, demonstrating significant improvement from baseline in EASI score and reduced itch compared to vehicle
- Results presented at EADV support planned initiation of global, pivotal Phase 3 program
“The positive results of this Phase 2 study demonstrate the potential of
ruxolitinib cream to offer a novel, effective non-steroidal topical
therapy to the millions of patients suffering from AD,” said
Key study results included:
- Significantly improved EASI score in the ruxolitinib cream 1.5% BID arm versus vehicle at Week 4 (71.6 percent vs. 15.5 percent improvement; P<0.001), the primary endpoint, and improvement (meeting the criteria for non-inferiority) in EASI score versus the active control, triamcinolone 0.1% cream (a mid-potency topical corticosteroid), at Week 4 (71.6 percent vs. 59.8 percent improvement), a secondary endpoint.
- Significantly improved EASI scores in the ruxolitinib cream 1.5% BID arm versus vehicle at Weeks 2 and 8 (52.7 percent vs. 4.8 percent and 78.5 percent vs. 26.9 percent, respectively; P<0.001).
- Significantly greater changes in EASI score in the once daily (QD) ruxolitinib cream 1.5% and 0.5% arms versus vehicle at Week 4 (1.5% QD [67.0 percent vs. 15.5 percent improvement], 0.5% QD [52.2 percent vs. 15.5 percent improvement]; P<0.001).
- Significantly more Investigator’s Global Assessment (IGA) responders – a measure of disease severity – in the ruxolitinib cream 1.5% BID arm versus vehicle at Week 4 (38.0 percent vs. 7.7 percent; P<0.001), and greater IGA response rates across other ruxolitinib arms versus vehicle.
- Rapid and sustained reductions in itch numerical rating scale (NRS) score observed as early as within two days from the initiation of therapy (ruxolitinib cream 1.5% cream BID vs. vehicle, ‒1.8 vs. ‒0.2; P<0.0001), and a more pronounced reduction in itch with ruxolitinib cream 1.5% BID and QD than with triamcinolone cream 0.1% BID.
Ruxolitinib cream was well-tolerated at all dosage strengths and was not associated with clinically-significant application site reactions. All treatment-related adverse events were Grade 1 or Grade 2 in severity.
Ruxolitinib cream is the first JAK1/JAK2 inhibitor to exhibit positive results as a topical monotherapy in the AD patient population. Over-activity of the JAK signaling pathway has been shown to drive inflammation involved in the pathogenesis of AD. These data support the planned initiation of a global, pivotal Phase 3 program, for which preparations are already underway.
"There is no cure for AD, and it continues to be a major therapeutic
challenge for patients, primary care providers and specialists. Though
topical corticosteroids have been a mainstay in treatment of AD for
decades, their utility has been limited due to significant side effects
associated with long-term use,” said principal investigator of the
About Atopic Dermatitis
Atopic dermatitis (AD) is a common chronic disease characterized by
inflammation of the skin. Approximately 11 million people in
About the Study
The safety and efficacy of ruxolitinib cream in adults with atopic
dermatitis (AD) were evaluated in an
Patients with AD on 3 to 20 percent of their body surface area, with an IGA score of 2 to 3, were equally randomized across six treatment-arms, including: twice daily (BID) ruxolitinib 1.5% cream; once daily (QD) ruxolitinib 0.15%, 0.5% or 1.5% cream; vehicle (non-medicated cream); and active control (triamcinolone 0.1% cream [TAC], a mid-potency topical corticosteroid). All patients received eight weeks of blinded study treatment; the TAC arm received four weeks of TAC followed by four weeks of vehicle; and there was an additional four weeks of open-label ruxolitinib 1.5% cream BID.
The primary efficacy endpoint was mean percentage change from baseline in Eczema Area and Severity Index (EASI score) – a measurement of the extent and severity of AD – at Week 4 in the ruxolitinib 1.5% BID arm versus vehicle. Key secondary endpoints included percent change from baseline in EASI score at Week 4 in the other ruxolitinib cream arms versus vehicle BID and versus triamcinolone 0.1% cream; the proportion of patients achieving an IGA score of 0 (clear) to 1 (almost clear) with at least a 2-point improvement from baseline; the proportion of patients achieving at least a 75 percent improvement from baseline in EASI (EASI75); itch numerical rating scale (NRS); and safety through 12 weeks of dosing.
For more information about the study, please visit https://clinicaltrials.gov/ct2/show/NCT03011892.
Except for the historical information set forth herein, the matters set
forth in this release contain predictions, estimates and other
forward-looking statements, including statements regarding the potential
of ruxolitinib cream to meaningfully improve the outcomes of patients
with atopic dermatitis and plans to initiate a pivotal study. These
forward-looking statements are based on Incyte’s current expectations
and subject to risks and uncertainties that may cause actual results to
differ materially, including scheduling and related issues with respect
to study initiation, unanticipated developments in and risks related to
the efficacy or safety of ruxolitinib cream for the treatment of atopic
dermatitis, the results of additional data and additional analyses of
data from this study, actions taken by regulatory authorities, and other
risks detailed from time to time in Incyte’s reports filed with the