Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Randomized Controlled Trial
. 2023 Jan;37(1):137-146.
doi: 10.1111/jdv.18571. Epub 2022 Sep 21.

Rapid pruritus reduction with ruxolitinib cream treatment in patients with atopic dermatitis

Andrew Blauvelt  1 , Leon Kircik  2 , Kim A Papp  3 , Eric L Simpson  4 , Jonathan I Silverberg  5 , Brian S Kim  2 , Shawn G Kwatra  6 , Michael E Kuligowski  7 , May E Venturanza  7 , Shaoceng Wei  7 , Jacek C Szepietowski  8
Affiliations
Randomized Controlled Trial

Rapid pruritus reduction with ruxolitinib cream treatment in patients with atopic dermatitis

Andrew Blauvelt et al. J Eur Acad Dermatol Venereol. 2023 Jan.

Abstract

Background: Ruxolitinib cream is a topical formulation of ruxolitinib, a Janus kinase (JAK) 1/JAK2 inhibitor.

Objectives: To report timing and magnitude of effect of ruxolitinib cream on itch in patients with atopic dermatitis (AD), a highly pruritic inflammatory skin disease.

Methods: Two phase 3 trials (TRuE-AD1 [NCT03745638]/TRuE-AD2 [NCT03745651]) enrolled patients aged ≥12 years with AD for ≥2 years, Investigator's Global Assessment score of 2 or 3, and 3%-20% affected body surface area. Patients (total N = 1249; median age, 32 years) were randomised (2:2:1) to twice daily 0.75% ruxolitinib cream, 1.5% ruxolitinib cream or vehicle cream for 8 weeks of double-blinded treatment. Worst itch was measured using the numerical rating scale (NRS).

Results: Significantly more patients who applied ruxolitinib cream (either strength) achieved a ≥2-point itch reduction (NRS2) within approximately 12 h versus vehicle (0.75%/1.5% ruxolitinib cream, 16.3%/13.1%; vehicle, 6.9%; both P < 0.05), with further improvements through Week 8 (58.3%/65.1% vs 29.4%; both P < 0.0001). A ≥4-point itch reduction (NRS4) was achieved by significantly more patients who applied 0.75%/1.5% ruxolitinib cream versus vehicle by Day 2 (8.9%/11.2% vs 2.1%; P < 0.005); higher rates were observed at Week 8 (41.5%/51.5% vs 15.8%; P < 0.0001). Median time for the 0.75%/1.5% ruxolitinib cream groups to achieve NRS4 from baseline was 15.0/13.0 days; this endpoint was not reached by the vehicle group.

Conclusions: Ruxolitinib cream demonstrated rapid improvement in itch in patients with mild to moderate AD that was sustained for 8 weeks. Significantly more patients applying ruxolitinib cream achieved itch NRS2 within approximately 12 h and itch NRS4 by Day 2 versus vehicle.

PubMed Disclaimer

Conflict of interest statement

AB has served as a scientific advisor and/or clinical study investigator for AbbVie, Abcentra, Aligos, Almirall, Amgen, Arcutis, Arena, Aslan, Athenex, Boehringer Ingelheim, Bristol Myers Squibb, Dermavant, EcoR1, Eli Lilly and Company, Evommune, Forte, Galderma, Incyte Corporation, Janssen, Landos, LEO Pharma, Novartis, Pfizer, Rapt, Regeneron, Sanofi Genzyme, Sun Pharma, UCB Pharma, and Vibliome. LK has served as an investigator, consultant, or speaker for AbbVie, Amgen, Anaptys, Arcutis, Dermavant, Eli Lilly, Glenmark, Incyte Corporation, Kamedis, LEO Pharma, L'Oreal, Menlo Therapeutics, Novartis, Ortho Dermatologics, Pfizer, Regeneron, Sanofi, Sun Pharma, and Taro. KP has received honoraria or clinical research grants 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, Gilead, GlaxoSmithKline, Incyte Corporation, InflaRx, Janssen, Kyowa Hakko Kirin, LEO Pharma, 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. ELS is an investigator for AbbVie, Eli Lilly, Galderma, Kyowa Hakko Kirin, LEO Pharma, Merck, Pfizer, and Regeneron and is a consultant with honorarium for AbbVie, Eli Lilly, Forte Bio, Galderma, Incyte Corporation, LEO Pharma, Menlo Therapeutics, Novartis, Pfizer, Regeneron, Sanofi Genzyme, and Valeant. JIS received honoraria for advisory board, speaker, and consultant services from AbbVie, Asana, Bluefin, Boehringer Ingelheim, Celgene, Dermavant, Dermira, Eli Lilly, Galderma, GlaxoSmithKline, Glenmark, Incyte Corporation, Kiniksa, LEO Pharma, Menlo, Novartis, Pfizer, Realm, Regeneron, and Sanofi and research grants for investigator services from GlaxoSmithKline and Galderma. BSK has served as a consultant to AbbVie, Almirall, Amagma, Cara Therapeutics, Daewoong, Incyte Corporation, OM Pharma, and Pfizer; has served on advisory boards for AstraZeneca, Boehringer Ingelheim, Cara Therapeutics, Celgene Corporation, Regeneron Pharmaceuticals, Sanofi Genzyme, and Trevi Therapeutics; is a shareholder in Locus Biosciences; and has a pending patent for JAK inhibitors in chronic itch. SGK has served as an advisory board member or consultant for AbbVie, Galderma, Incyte Corporation, Kiniksa Pharmaceuticals, Regeneron Pharmaceuticals, and Pfizer Inc and has received grant funding from Pfizer Inc, Galderma, and Kiniksa Pharmaceuticals. MEK and MEV were employees and shareholders of Incyte Corporation at the time of this study. SW is an employee and shareholder of Incyte Corporation. JCS has served as an advisor for AbbVie, LEO Pharma, Menlo Therapeutics, Novartis, Pierre Fabre, and Trevi; has received speaker honoraria from AbbVie, Eli Lilly, Janssen‐Cilag, LEO Pharma, Novartis, Sanofi‐Genzyme, Sun Pharma; and has received clinical trial funding from AbbVie, Almirall, Amgen, Galapagos, Holm, Incyte Corporation, InflaRX, Janssen‐Cilag, Menlo Therapeutics, Merck, Novartis, Pfizer, Regeneron, Trevi, and UCB.

Figures

FIGURE 1
FIGURE 1
Mean daily worst itch NRS score.* BL, baseline; NRS, numerical rating scale; RUX, ruxolitinib. *Mean change in daily itch NRS score from baseline was significant on Day 1 (approximately 12 h after first application) for 0.75% and 1.5% ruxolitinib cream vs vehicle (both P < 0.02)
FIGURE 2
FIGURE 2
SCORAD itch scores through to Week 8 for (a) vehicle, (b) 0.75% RUX cream, and (c) 1.5% RUX cream based on evaluations undertaken at all study visits between baseline and Week 8 with a 7‐day recall period. RUX, ruxolitinib; SCORAD, SCORing Atopic Dermatitis
FIGURE 3
FIGURE 3
Representative clinical images (excoriations as a proxy measure of pruritus). BL, baseline; NRS, numerical rating scale; RUX, ruxolitinib
FIGURE 4
FIGURE 4
Proportion of patients achieving itch NRS2 (a) during the first week of treatment and (b) throughout the 8‐week VC period; (c) time to reach itch NRS2 in patients with baseline itch NRS ≥2 in the VC period. BL, baseline; NRS, numerical rating scale; NRS2, ≥2‐point improvement in worst itch NRS score from baseline; RUX, ruxolitinib; VC, vehicle‐controlled. *P < 0.05. **P < 0.01. ****P < 0.0001 vs vehicle. †Patients in the analysis had an itch NRS score ≥2 at baseline. Patients with missing post‐baseline values were imputed as nonresponders at Weeks 2, 4, and 8. ‡The Day 1 assessment was done at the end of the day, approximately 12 h after the first application in the morning
FIGURE 5
FIGURE 5
Proportion of patients achieving itch NRS4 (a) during the first week of treatment and (b) throughout the 8‐week VC period; (c) time to reach itch NRS4 in patients with baseline itch NRS ≥4 in the VC period. BL, baseline; NRS, numerical rating scale; NRS4, ≥4‐point improvement in worst itch NRS score from baseline; RUX, ruxolitinib; VC, vehicle‐controlled. **P < 0.01. ***P < 0.001. ****P < 0.0001. †Patients in the analysis had an itch NRS score ≥4 at baseline. Patients with missing post‐baseline values were imputed as nonresponders at Weeks 2, 4 and 8. ‡Itch assessments were done at the end of the day, approximately 12 h after the first morning application; thus, the assessment on Day 2 was done approximately 36 h after the first application in the morning on Day 1
FIGURE 6
FIGURE 6
Response rates in achieving itch NRS4 at Week 8 based on demographics and baseline clinical characteristics. BSA, body surface area; EASI, Eczema Area and Severity Index; IGA, Investigator's Global Assessment; NRS, numerical rating scale; NRS4, ≥4‐point improvement in worst itch NRS score from baseline; RUX, ruxolitinib. †Patients in the analysis had an itch NRS score ≥4 at baseline
See this image and copyright information in PMC

References

    1. Wei W, Anderson P, Gadkari A, Blackburn S, Moon R, Piercy J, et al. Extent and consequences of inadequate disease control among adults with a history of moderate to severe atopic dermatitis. J Dermatol. 2018;45:150–7. - PMC - PubMed
    1. Sayaseng KY, Vernon P. Pathophysiology and management of mild to moderate pediatric atopic dermatitis. J Pediatr Health Care. 2018;32:S2–S12. - PubMed
    1. Girolomoni G, Luger T, Nosbaum A, Gruben D, Romero W, Llamado LJ, et al. The economic and psychosocial comorbidity burden among adults with moderate‐to‐severe atopic dermatitis in Europe: analysis of a cross‐sectional survey. Dermatol Ther (Heidelb). 2021;11:117–30. - PMC - PubMed
    1. Kwatra SG, Gruben D, Fung S, DiBonaventura M. Psychosocial comorbidities and health status among adults with moderate‐to‐severe atopic dermatitis: a 2017 US National Health and Wellness Survey analysis. Adv Ther. 2021;38:1627–37. - PMC - PubMed
    1. Whang KA, Khanna R, Williams KA, Mahadevan V, Semenov Y, Kwatra SG. Health‐related QOL and economic burden of chronic pruritus. J Invest Dermatol. 2021;141:754–60. - PubMed

Publication types

Grants and funding