Association Between Early Clinical Responses and Long-Term Outcomes With Ruxolitinib Cream Treatment in Mild to Moderate Atopic Dermatitis

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Vimal H. Prajapati
Bob Geng
Andrew Blauvelt
Lawrence F. Eichenfield
Parbeer Grewal
Leon Kircik
Peter Lio
Charles Lynde
Eric L. Simpson
Haobo Ren
Daniel Sturm
Grace Wong
Chih-ho Hong


Atopic dermatitis, Janus kinase inhibitor, Ruxolitinib cream


In the TRuE-AD1/2 studies, patients aged ≥12 years with atopic dermatitis (Investigator’s Global Assessment [IGA] 2/3; 3%–20% affected body surface area) were randomized (2:2:1) to twice-daily 0.75%/1.5% ruxolitinib cream or vehicle for an 8-week, double-blind period followed by a 44-week long-term safety (LTS) period of as-needed ruxolitinib cream. This analysis examines associations between Week 8 responder status to 1.5% ruxolitinib cream with LTS outcomes. At Week 8, 57.0% (244/428) of LTS-evaluable patients applying 1.5% ruxolitinib cream achieved IGA–Treatment Success (IGA-TS; IGA 0/1 with ≥2-grade improvement from baseline); 66.6% (285/428) achieved ≥75% improvement in Eczema Area and Severity Index from baseline (EASI-75); 45.8% (196/428) achieved Itch numerical rating scale 0/1 (NRS 0/1). For patients with ≥2 visits (every 4 weeks) during LTS, mean percentages of visits with clear/almost clear skin were 83.2% vs 59.7%, 82.2% vs 54.9%, and 77.3% vs 70.1% for Week 8 IGA-TS, EASI-75, and Itch NRS 0/1 responders vs nonresponders, respectively. Mean percentages of visits with clear/almost clear skin were similar regardless of time to achieve IGA-TS (83.4%/77.4%/81.9% for those achieving at Week 2/4/8), EASI-75 (80.7%/78.8%/81.6%), and Itch NRS 0/1 (75.8%/70.7%/72.8%). During LTS, mean (SD) cumulative treatment-free days due to complete clearance were 149.2 (86.43) vs 104.0 (89.10), 146.4 (88.43) vs 95.9 (83.55), and 142.6 (87.58) vs 124.4 (91.47) for Week 8 IGA-TS, EASI-75, and Itch NRS 0/1 responders vs nonresponders, respectively. Percentage of treatment-free days between study visits (between Weeks 8 and 12 vs Weeks 48 and 52) among Week 8 responders and nonresponders increased from 44.1% to 50.2% and from 16.3% to 42.3% for IGA-TS; from 41.2% to 49.9% and from 14.9% to 40.6% for EASI-75; from 39.8% to 49.4% and from 29.9% to 46.0% for itch NRS 0/1. In summary, efficacy responses achieved with 8-week ruxolitinib cream treatment are associated with higher disease control in LTS; however, nonresponders approach similar disease control with continued treatment. As-needed ruxolitinib cream monotherapy demonstrated substantial long-term disease control regardless of time to first response achievement.


1. Langan SM, et al. Lancet. 2020;396(10247):345-360.

2. Quintás-Cardama A, et al. Blood. 2010;115(15):3109-3117.

3. Opzelura™ (ruxolitinib cream). Full Prescribing Information, Incyte Corporation, Wilmington, DE, 2023.

4. Papp K, et al. J Am Acad Dermatol. 2021;85(4):863-872.

5. Blauvelt A, et al. Ruxolitinib Cream Demonstrates Maintenance of Disease and Symptom Control With As-Needed Use in Adults and Adolescents With Atopic Dermatitis: Pooled Analysis From the Long-Term Safety Periods of Two Phase 3 Studies. Presented at: American Academy of Dermatology Annual Meeting; March 17-21, 2023; New Orleans, LA, USA.

6. Geng B, et al. Ruxolitinib Cream Demonstrates Durable Long-Term Disease Control With As-Needed Use in Patients With Atopic Dermatitis. Presented at: American College of Allergy, Asthma & Immunology Annual Scientific Meeting; November 11, 2023; Anaheim, CA, USA.

7. Papp K, et al. J Am Acad Dermatol. 2023;88(5):1008-1016.

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