Journal of the American Academy of Dermatology · 2025
Efficacy and safety of ruxolitinib cream for the treatment of moderate to severe chronic hand eczema: Results from a 16-week, multicenter, randomized, double-blind study.
СтатьяМногоцентровое исследованиеРандомизированное исследованиеКлиническое исследование II фазыПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод в очереди
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Zirwas Matthew, Fowler Joseph F, Tsianakas Athanasios, Devani Alim R, Halden Philippa, Lai Zhihong, Kuo YuTzu, Nawaz Haq, Stein Gold Linda F
Аннотация
BACKGROUND: Chronic hand eczema (CHE) is a well-recognized inflammatory disorder.
OBJECTIVE: To evaluate the efficacy and safety of 1.5% ruxolitinib cream in adults with moderate to severe CHE.
METHODS: This phase 2 study enrolled adults with CHE from North America and Europe, an Investigator's Global Assessment-CHE score of 3/4, ≥1 prior CHE therapy, and no current or recent history (≤5 y) of atopic dermatitis. Patients were randomized 1:1 to twice-daily 1.5% ruxolitinib cream or vehicle cream for 16 weeks.
RESULTS: Among 186 randomized patients, most who applied ruxolitinib cream achieved a score of 0 (clear) or 1 (almost clear) on the Investigator's Global Assessment-CHE scale with a 2-grade improvement from baseline at Week 16 (53.2% vs 10.9% [vehicle]; P < .0001; primary endpoint). Itch improvements (≥4-point improvement in numerical rating scale) were reported on Day 2 (9.1% vs 2.4%) and reached statistical significance on Day 7 (27.4% vs 9.0%; P = .0024). Improvements in skin pain and quality of life were reported during the study. Ruxolitinib cream was well tolerated, with no new safety signals and few (3.2%) application site reactions.
LIMITATIONS: Relatively small sample size.
CONCLUSION: Ruxolitinib cream represents an effective treatment option for nonatopic CHE subtypes that are not controlled with standard therapies.
OBJECTIVE: To evaluate the efficacy and safety of 1.5% ruxolitinib cream in adults with moderate to severe CHE.
METHODS: This phase 2 study enrolled adults with CHE from North America and Europe, an Investigator's Global Assessment-CHE score of 3/4, ≥1 prior CHE therapy, and no current or recent history (≤5 y) of atopic dermatitis. Patients were randomized 1:1 to twice-daily 1.5% ruxolitinib cream or vehicle cream for 16 weeks.
RESULTS: Among 186 randomized patients, most who applied ruxolitinib cream achieved a score of 0 (clear) or 1 (almost clear) on the Investigator's Global Assessment-CHE scale with a 2-grade improvement from baseline at Week 16 (53.2% vs 10.9% [vehicle]; P < .0001; primary endpoint). Itch improvements (≥4-point improvement in numerical rating scale) were reported on Day 2 (9.1% vs 2.4%) and reached statistical significance on Day 7 (27.4% vs 9.0%; P = .0024). Improvements in skin pain and quality of life were reported during the study. Ruxolitinib cream was well tolerated, with no new safety signals and few (3.2%) application site reactions.
LIMITATIONS: Relatively small sample size.
CONCLUSION: Ruxolitinib cream represents an effective treatment option for nonatopic CHE subtypes that are not controlled with standard therapies.