Effects of ruxolitinib cream on pruritus and quality of life in atopic dermatitis: Results from a phase 2, randomized, dose-ranging, vehicle- and active-controlled study - 18/03/20
, Kang Sun, PhD b, Kim Papp, MD, PhD c, May Venturanza, MD b, Adnan Nasir, MD, PhD d, Michael E. Kuligowski, MD, PhD, MBA bAbstract |
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.
Le texte complet de cet article est disponible en PDF.Graphical abstract |
Key words : atopic dermatitis, burden of disease, itch, JAK inhibitor, Janus kinase, pruritus, quality of life, ruxolitinib, Skindex-16
Abbreviations used : AD, CRI, JAK, MCID, NRS, QoL, RUX
Plan
| Funding sources: Supported by Incyte Corporation. |
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| Disclosure: Dr Kim has served as a consultant to AbbVie, Cara Therapeutics, Concert Pharmaceuticals, Incyte Corporation, Menlo Therapeutics, and Pfizer; has served on advisory boards for Cara Therapeutics, Celgene Corporation, Kiniksa Pharmaceuticals, Menlo Therapeutics, Regeneron Pharmaceuticals, Sanofi, and Theravance Biopharma; is a shareholder in Locus Biosciences and Nuogen Pharma; has a pending patent with Nuogen Pharma for JAK inhibitors in chronic itch; and is founder and chief scientific officer of Nuogen Pharma. Dr Papp has received honoraria or clinical research grant as a consultant, speaker, scientific officer, advisory board member, and/or steering committee member for AbbVie, Akros, Amgen, Anacor, Arcutis, Astellas, Bausch Health/Valeant, Baxalta, Boehringer Ingelheim, Bristol-Myers Squibb, Can Fite, Celgene, Coherus, Dermira, Dow Pharmaceuticals, Eli Lilly, Galderma, Genentech, Gilead, GlaxoSmithKline, InflaRx, Janssen, Kyowa Hakko Kirin, Leo, Medimmune, Meiji Seika Pharma, Merck (MSD), Merck Serono, Mitsubishi Pharma, Moberg Pharma, Novartis, Pfizer, PRCL Research, Regeneron, Roche, Sanofi-Aventis/Genzyme, Sun Pharmaceuticals, Takeda, and UCB. Dr Nasir has served as an investigator for Kiniksa, Escalier Biosciences, Ironwood, Galderma, Affibody, Pfizer, Allergan, Lilly, AbbVie, Dermira, Leo Pharma, Asana, Incyte, Foamix, Cutanea, Biorasi, Sienna, Valeant, Menlo, Bristol-Myers Squibb, Trevi, Aclaris, Gage, and Brickell. Drs Sun, Venturanza, and Kuligowski are employees and shareholders of Incyte Corporation. |
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| Presented at the American Academy of Dermatology meeting, Washington, DC, March 1-5, 2019, and the Revolutionizing Atopic Dermatitis meeting, Chicago, IL, April 6-7, 2019. |
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| IRB approval status: Reviewed and approved by each site's institutional review board. |
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| Reprints not available from the authors. |
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