Brian S Kim1, Kang Sun2, Kim Papp3, May Venturanza2, Adnan Nasir4, Michael E Kuligowski2. 1. Center for the Study of Itch and Sensory Disorders, Washington University School of Medicine, St Louis, Missouri. Electronic address: briankim@wustl.edu. 2. Incyte Corporation, Wilmington, Delaware. 3. K. Papp Clinical Research and Probity Medical Research, Waterloo, Ontario, Canada. 4. Wake Research Associates LLC, Raleigh, North Carolina.
Abstract
BACKGROUND:Atopic dermatitis (AD), a chronic, highly pruritic skin disorder, impairs quality of life (QoL). Janus kinase inhibitors suppress inflammatory and pruritus-associated cytokine signaling in AD. OBJECTIVE: To report the effects of ruxolitinib (RUX) cream on itch and QoL in AD. METHODS: A total of 307 adult patients with an Investigator's Global Assessment (score of 2 or 3) and 3% to 20% affected body surface area were randomly assigned for 8 weeks to receive double-blind treatment with RUX (1.5% twice daily, 1.5% once daily, 0.5% once daily, or 0.15% once daily), vehicle twice daily, or triamcinolone cream (0.1% twice daily for 4 weeks then vehicle for 4 weeks). Itch was measured by using the numerical rating scale, and patient QoL was assessed with Skindex-16. RESULTS: Improvements in itch numerical rating scale and Skindex-16 were observed with RUX cream. Overall, 42.5% of patients who applied 1.5% RUX twice daily experienced minimal clinically important difference in itch within 36 hours of treatment (vehicle, 13.6%; P < .01); near-maximal improvement was observed by week 4. Itch reduction was associated with improved QoL burden (Pearson correlation, 0.67; P < .001). Significant improvements in Skindex-16 overall scores were noted at week 2. LIMITATIONS: Facial AD lesions were not treated. CONCLUSION:RUX cream provides a clinically meaningful reduction in itch and QoL burden.
RCT Entities:
BACKGROUND: Atopic dermatitis (AD), a chronic, highly pruritic skin disorder, impairs quality of life (QoL). Janus kinase inhibitors suppress inflammatory and pruritus-associated cytokine signaling in AD. OBJECTIVE: To report the effects of ruxolitinib (RUX) cream on itch and QoL in AD. METHODS: A total of 307 adult patients with an Investigator's Global Assessment (score of 2 or 3) and 3% to 20% affected body surface area were randomly assigned for 8 weeks to receive double-blind treatment with RUX (1.5% twice daily, 1.5% once daily, 0.5% once daily, or 0.15% once daily), vehicle twice daily, or triamcinolone cream (0.1% twice daily for 4 weeks then vehicle for 4 weeks). Itch was measured by using the numerical rating scale, and patient QoL was assessed with Skindex-16. RESULTS: Improvements in itch numerical rating scale and Skindex-16 were observed with RUX cream. Overall, 42.5% of patients who applied 1.5% RUX twice daily experienced minimal clinically important difference in itch within 36 hours of treatment (vehicle, 13.6%; P < .01); near-maximal improvement was observed by week 4. Itch reduction was associated with improved QoL burden (Pearson correlation, 0.67; P < .001). Significant improvements in Skindex-16 overall scores were noted at week 2. LIMITATIONS: Facial AD lesions were not treated. CONCLUSION:RUX cream provides a clinically meaningful reduction in itch and QoL burden.
Authors: Fang Wang; Anna M Trier; Fengxian Li; Seonyoung Kim; Zhen Chen; Jiani N Chai; Madison R Mack; Stephanie A Morrison; Jennifer D Hamilton; Jinok Baek; Ting-Lin B Yang; Aaron M Ver Heul; Amy Z Xu; Zili Xie; Xintong Dong; Masato Kubo; Hongzhen Hu; Chyi-Song Hsieh; Xinzhong Dong; Qin Liu; David J Margolis; Marius Ardeleanu; Mark J Miller; Brian S Kim Journal: Cell Date: 2021-01-14 Impact factor: 66.850