Efficacy and Safety of Ruxolitinib Cream for the Treatment of Atopic Dermatitis: Results From Two Phase 3, Randomized, Double-Blind Studies

Kim Papp, Jacek C Szepietowski, Leon Kircik, Darryl Toth, Lawrence F Eichenfield, Donald Y M Leung, Seth B Forman, May E Venturanza, Kang Sun, Michael E Kuligowski, Eric L Simpson
Journal of the American Academy of Dermatology 2021 May 3

BACKGROUND: Ruxolitinib (RUX) cream demonstrated potent anti-inflammatory and antipruritic efficacy in a phase 2 study in adults with atopic dermatitis (AD).

OBJECTIVE: To evaluate 8-week efficacy and safety in two phase 3 studies of RUX cream in patients with AD METHODS: TRuE-AD1 (NCT03745638) and TRuE-AD2 (NCT03745651) enrolled patients aged ≥12 years with AD for ≥2 years, an IGA score of 2/3, and 3% to 20% affected body surface area. Patients were randomized 2:2:1 to twice-daily 0.75% RUX cream, 1.5% RUX cream, or vehicle cream for 8 continuous weeks. The primary endpoint was IGA treatment success (IGA-TS) at Week 8 (IGA score of 0/1 and ≥2-grade improvement from baseline).

RESULTS: In TRuE-AD1/TRuE-AD2, 631/618 patients were randomized (631/577 analyzed for efficacy). Significantly more patients achieved IGA-TS with 0.75% RUX cream (50.0%/39.0%) and 1.5% RUX cream (53.8%/51.3%) versus vehicle (15.1%/7.6%; P<0.0001) at Week 8. Significant itch reductions versus vehicle were reported within 12 hours of first application of 1.5% RUX (P<0.05). Application site reactions were infrequent (<1%) and lower with RUX versus vehicle; none were clinically significant.

LIMITATIONS: Longer-term safety data are not yet available.

CONCLUSIONS: RUX cream showed anti-inflammatory and prompt antipruritic effects with superior efficacy versus vehicle and was well tolerated.

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