Kim Papp1, Jacek C Szepietowski2, Leon Kircik3, Darryl Toth4, Lawrence F Eichenfield5, Donald Y M Leung6, Seth B Forman7, May E Venturanza8, Kang Sun8, Michael E Kuligowski8, Eric L Simpson9. 1. K. Papp Clinical Research and Probity Medical Research, Waterloo, Ontario, Canada. Electronic address: kapapp@probitymedical.com. 2. Department of Dermatology, Venereology, and Allergology, Wroclaw Medical University, Wroclaw, Poland. 3. Icahn School of Medicine at Mount Sinai, New York, New York. 4. XLR8 Medical Research and Probity Medical Research, Windsor, Ontario, Canada. 5. Departments of Dermatology and Pediatrics, University of California San Diego, San Diego, California. 6. Division of Pediatric Allergy and Clinical Immunology, Department of Pediatrics, National Jewish Health, Denver, Colorado. 7. ForCare Clinical Research, Tampa, Florida. 8. Incyte Corporation, Wilmington, Delaware. 9. Oregon Health & Science University, Portland, Oregon.
Abstract
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 2 phase 3 studies of RUX cream in patients with AD. METHODS: Topical Ruxolitinib Evaluation in Atopic Dermatitis Study 1 (NCT03745638) and Study 2 (NCT03745651) enrolled patients aged ≥12 years with AD for ≥2 years, an Investigator's Global Assessment score of 2/3, and 3%-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 Investigator's Global Assessment treatment success at week 8 (Investigator's Global Assessment score of 0/1 and ≥2-grade improvement from baseline). RESULTS: In the Topical Ruxolitinib Evaluation in Atopic Dermatitis Study 1 and 2, 631 and 618 patients were randomized (631/577 analyzed for efficacy). Significantly more patients achieved Investigator's Global Assessment treatment success 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 < .0001) at week 8. Significant itch reductions versus vehicle were reported within 12 hours of first application of 1.5% RUX (P < .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.
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 2 phase 3 studies of RUX cream in patients with AD. METHODS: Topical Ruxolitinib Evaluation in Atopic Dermatitis Study 1 (NCT03745638) and Study 2 (NCT03745651) enrolled patients aged ≥12 years with AD for ≥2 years, an Investigator's Global Assessment score of 2/3, and 3%-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 Investigator's Global Assessment treatment success at week 8 (Investigator's Global Assessment score of 0/1 and ≥2-grade improvement from baseline). RESULTS: In the Topical Ruxolitinib Evaluation in Atopic Dermatitis Study 1 and 2, 631 and 618 patients were randomized (631/577 analyzed for efficacy). Significantly more patients achieved Investigator's Global Assessment treatment success 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 < .0001) at week 8. Significant itch reductions versus vehicle were reported within 12 hours of first application of 1.5% RUX (P < .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.
Authors: El-Bdaoui Haddad; Sonya L Cyr; Kazuhiko Arima; Robert A McDonald; Noah A Levit; Frank O Nestle Journal: Dermatol Ther (Heidelb) Date: 2022-05-21