Ruxolitinib Cream Shows Promise in Treating Adolescent Atopic Dermatitis: Study

The study, published in the American Journal of Clinical Dermatology, showed that 1.5% ruxolitinib cream may result in significant anti-inflammatory and antipruritic effects within the subset of adolescent patients with atopic dermatitis. Long-term, as-needed utilization of the drug is well tolerated and maintains disease control.

Atopic Dermatitis, commonly known as eczema, is a chronic inflammatory skin condition characterized by intense itching, redness, and dryness. While it affects individuals of all ages, adolescents often experience profound psychological and social impacts due to the visible nature of the condition.

A topical formulation of ruxolitinib, a Janus kinase (JAK) 1/JAK2 inhibitor, demonstrated efficacy and safety among adolescents/adults in two phase 3 studies (TRuE-AD1/TRuE-AD2). Lawrence F. Eichenfield, Rady Children’s Hospital, San Diego, CA, USA, and colleagues aimed to describe the efficacy and safety of 1.5% ruxolitinib cream versus vehicle and long-term disease control of ruxolitinib cream among adolescents aged 12–17 years from pooled phase 3 study data.

For this purpose, the researchers included patients [≥ 12 years old with AD for ≥ 2 years, Investigator’s Global Assessment score (IGA) 2/3, and 3–20% affected body surface area (BSA) at baseline]. They were randomized in a 2:2:1 ratio to ruxolitinib cream (0.75%/1.5%) or vehicle for eight weeks of continuous use followed by a long-term safety (LTS) period of up to 52 weeks with as-needed use.

Patients who were originally applying the vehicle were randomized 1:1 to 0.75%/1.5% ruxolitinib cream. Efficacy measures in the 8th week included ≥ 75% improvement in Eczema Area and Severity Index (EASI-75), IGA treatment success (IGA-TS; i.e., score of 0/1 with ≥ 2-grade improvement from baseline), and ≥ 4-point improvement in itch numerical rating scale (NRS4).

Disease control measures during the LTS period included an IGA score of 0 (clear) or 1 (almost clear) and a percentage that affected BSA. Safety assessment was done throughout the study.

The study revealed the following findings:

· Of 1249 randomized patients, 19.6% were 12–17 years. Of these, 45 patients were randomized to vehicle and 92 patients to 1.5% ruxolitinib cream.

· A total of 75.9% of patients continued on 1.5% ruxolitinib cream in the LTS period [89.1% continued on 1.5% ruxolitinib cream; 48.9% patients on the vehicle were reassigned to 1.5% ruxolitinib cream], and 79.8% of these patients completed the LTS period.

· At week 8, substantially more patients who applied 1.5% ruxolitinib cream versus vehicle achieved IGA-TS (50.6% versus 14.0%), NRS4 (52.1% versus 17.4%), and EASI-75 (60.9% versus 34.9%).

· The mean reduction in itch NRS scores was significantly greater in patients applying 1.5% ruxolitinib cream versus vehicle from day 2 [− 0.9 versus −0.2].

· During the LTS period, mean trough steady-state ruxolitinib plasma concentrations at weeks 12/52 were 27.2/15.5 nM.

· The percentage of patients achieving an IGA score of 0 or 1 was sustained or further increased with 1.5% ruxolitinib cream; the mean affected BSA was generally low (< 3%; i.e., mild disease).

· Through 52 weeks, application site reactions occurred in 1.8% of adolescent patients applying 1.5% ruxolitinib cream at any time; no patients had severe adverse events.

· There were no serious infections, major adverse cardiovascular events, malignancies, or thromboembolic events.

The findings suggest that in adolescents with atopic dermatitis, 1.5% ruxolitinib cream demonstrated antipruritic and anti-inflammatory effects, which were comparable with those in the overall study population.

Furthermore, adolescents maintained disease control over 52 weeks with as-needed use, and ruxolitinib cream was well tolerated.

Reference:

Eichenfield, L.F., Simpson, E.L., Papp, K. et al. Efficacy, Safety, and Long-Term Disease Control of Ruxolitinib Cream Among Adolescents with Atopic Dermatitis: Pooled Results from Two Randomized Phase 3 Studies. Am J Clin Dermatol (2024). https://doi.org/10.1007/s40257-024-00855-2