Efficacy and Safety of Ruxolitinib Cream by Anatomic Region in Children Aged 2 to 11 Years With Atopic Dermatitis: Results From TRuE-AD3

Main Article Content

Dareen Siri
Amy Paller
April Armstrong
Linda Stein Gold
Howard Kallender
Daniel Sturm
Haobo Ren
Lawrence Eichenfield

Keywords

Ruxolitinib Cream, Atopic Dermatitis, Anatomic Region, Children

Abstract

Atopic dermatitis (AD) is a chronic, pruritic inflammatory skin disease. Ruxolitinib (Janus kinase [JAK]1/JAK2 inhibitor) cream has demonstrated efficacy and safety in patients aged ≥2 years with AD. In adolescents (aged ≥12 y) and adults with AD, application of ruxolitinib cream resulted in significant improvements across all anatomic regions vs vehicle. The objective of this analysis was to evaluate the efficacy and safety of ruxolitinib cream by anatomic region in the randomized, double-blind, phase 3 TRuE-AD3 study (NCT04921969). Children aged 2–11 years with AD for ≥3 months and an Investigator’s Global Assessment score of 2/3 were randomized 2:2:1 to apply 0.75% or 1.5% ruxolitinib cream twice daily (BID) or vehicle BID for 8 weeks. Efficacy was evaluated using the Eczema Area and Severity Index (EASI) subscores for head/neck, trunk, upper limbs, and lower limbs. Of 330 patients in TRuE-AD3, the mean (SD) age was 6.5 (2.9) years, and 179 patients (54.2%) were female; the mean (SD) EASI score was 8.6 (5.4). Improvements in EASI score were demonstrated with 0.75% and 1.5% ruxolitinib cream vs vehicle at first observation (Week 2), with statistically significant differences (at 0.05 alpha level and all P values below are nominal) at Week 8 in the head and neck (−0.63 [P=0.0108] and −0.70 [P=0.0011] vs −0.41), trunk (−0.98 [P=0.0310] and −1.18 [P=0.0003] vs −0.70), upper limbs (−1.81 [P<0.0001] and −2.06 [P<0.0001] vs −1.18), and lower limbs (−2.91 [P<0.0001] and −3.23 [P<0.0001] vs −1.43). Improvements in induration/papulation/edema, erythema, excoriation, and lichenification were observed for both strengths of ruxolitinib cream vs vehicle in all regions at Week 2, with statistical significance (at 0.05 alpha level) in nearly all AD signs and regions at Week 8. Ruxolitinib cream was well tolerated in both treatment groups (n=264), with 4.5% of patients experiencing application site reactions, which was similar to the frequency of application site reactions (4.3%) among patients with head/neck involvement (n=161) . In conclusion, ruxolitinib cream demonstrated significant improvements in AD vs vehicle in children with AD across anatomic regions, including on the head/neck, and was well tolerated. (Funding, Incyte Corporation)

References

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

2. Maarouf M, et al. Pediatr Dermatol. 2018;35(6):748-753.

3. Silverberg JI, et al. J Am Acad Dermatol. 2023;89(3):519-528.

4. Lio PA, et al. J Drugs Dermatol. 2020;19(10):943-948.

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

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

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

8. Eichenfield LF, et al. A phase 3 study of ruxolitinib cream in children aged 2–<12 years with atopic dermatitis (TRuE-AD3): 8-week
analysis. Presented at: 32nd European Academy of Dermatology and Venereology (EADV) Congress; October 11-14, 2023; Berlin, Germany.

9. Bissonnette R, et al. Ruxolitinib cream 1.5% twice daily for the treatment of extensive atopic dermatitis in children aged 2–11 years: 52-
week results from a maximum-use trial. Presented at: Revolutionizing Atopic Dermatitis Conference; June 8-10, 2024; Chicago, IL, USA.

10. Bissonnette R, et al. Am J Clin Dermatol. 2022;23(3):355-364.

11. Simpson EL, et al. J Dermatolog Treat. 2024;35(1):2310633.

12. Hanifin JM, et al. Exp Dermatol. 2001;10(1):11-18.

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