Incyte's ruxolitinib cream achieves main goal in second late-stage atopic dermatitis study

Incyte reported Wednesday that a topical cream version of its selective JAK1/JAK2 inhibitor ruxolitinib met both the primary and secondary endpoints of the Phase III TRuE-AD1 trial of adolescent and adult patients with mild-to-moderate atopic dermatitis. These latest top-line results follow data released last month demonstrating that ruxolitinib cream had also achieved the main goal of the identically-designed Phase III TRuE-AD2 study

"The successful outcomes of both…studies confirm the potential of ruxolitinib cream as an important, non-steroidal treatment option for the millions of patients suffering from atopic dermatitis," commented Jim Lee, who heads the company's inflammation and autoimmunity division. He added "we look forward to working with regulators as we seek approval of ruxolitinib cream as the first topical formulation of a JAK inhibitor" in this patient population. 

TRuE-AD1 enrolled 622 patients aged 12 years and older who were diagnosed with atopic dermatitis for at least two years. Patients with an Investigator's Global Assessment (IGA) score of 2 to 3 at baseline, and with atopic dermatitis on 3% to 20% of their body surface area, excluding the scalp, were randomised to receive one of two doses of ruxolitinib cream administered twice daily, or a non-medicated cream. As with TRuE-AD2, the primary endpoint of the TRuE-AD1 trial was an IGA Treatment Success (IGA-TS) score of 0 or 1, denoting "clear" or "almost clear" skin, with at least a two-point improvement from baseline after eight weeks. Similarly, in both trials, key secondary objectives include at least a 75% improvement from baseline on the Eczema Area and Severity Index (EASI75) and at least a four-point improvement in the itch Numerical Rating Scale (NRS). 

Incyte said that in TRuE-AD1, 50% of patients given the lower dose of ruxolitinib cream and 53.8% of those on the higher dose achieved IGA-TS, compared to 15.1% for patients in the vehicle control group. In addition, 56% and 62.1% of patients in the low- and high-dose ruxolitinib arms achieved EASI75, versus 24.6% for vehicle control. 

The company also provided more top-line data on the TRuE-AD2 findings, saying 39% and 51.3% of patients treated with low- and high-dose ruxolitinib cream, respectively, attained the primary IGA-TS endpoint, compared to 7.6% for controls. EASI75 was achieved by 51.5% of patients administered low-dose ruxolitinib cream, 61.8% of those in the high-dose arm and 14.4% of those given the non-medicated cream. Moreover, Incyte noted that a statistically-significant difference in itch reduction was observed for both dose strengths compared to vehicle control in both trials, while the overall rate of treatment emergent adverse events was comparable between all three arms. 

Incyte holds global rights for the development and commercialisation of ruxolitinib cream. Meanwhile, an oral formulation of the drug is already approved to treat myelofibrosis, polycythaemia vera and steroid-refractory acute graft-versus-host disease, with Incyte holding marketing rights in the US, where ruxolitinib is sold as Jakafi, and Novartis handling sales outside the US, where the product is known as Jakavi. 

For related analysis, see ViewPoints: Incyte’s post-ruxolitinib plans start to sharpen thanks to… ruxolitinib.

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