Ruxolitinib Cream Successfully Treats Patients With More Severe Atopic Dermatitis

Patients with more severe atopic dermatitis (AD) may be able to treat their condition with ruxolitinib cream and delay or prevent systemic therapy, according to a poster presented at the American Academy of Dermatology Virtual Meeting Experience, held April 23-26.¹

The poster included pooled results from the TRuE-AD1 and TRuE-AD2 trials, which randomized 1249 patients 2:2:1 to ruxolitinib cream 0.75% twice a day, ruxolitinib cream 1.5% twice a day, or placebo cream twice a day.

The subgroup analysis included patients with a baseline body surface area ≥ 10% and Eczema Area and Severity Index (EASI) ≥ 16. These patients with AD are typically eligible for either topic or systemic therapies. Of the total population of 1249 in the 2 studies, 81 patients were included in this subanalysis. Thirteen patients were given placebo, 36 were given 0.75% ruxolitinib, and 32 were given 1.5% ruxolitinib.

At least half of the patients on ruxolitinib 0.75% (50.0%) and ruxolitinib 1.5% (59.4%) achieved Investigator’s Global Assessment treatment success (IGA-TS) at week 8 compared with 0% of patients on placebo.

Patients on the ruxolitinib creams were also more likely to achieve ≥ 50% improvement in EASI (EASI-50), ≥ 75% improvement in EASI (EASI-75), and ≥ 90% improvement in EASI (EASI-90):

• EASI-50: 80.6% of patients on ruxolitinib 0.75%, 78.1% of patients on ruxolitinib 1.5% vs 38.5% on placebo
• EASI-75: 75.0% of patients on ruxolitinib 0.75%, 71.9% of patients on ruxolitinib 1.5% vs 7.7% on placebo
• EASI-90: 52.8% of patients on ruxolitinib 0.75%, 46.9% of patients on ruxolitinib 1.5% vs 7.7% on placebo

At least half of the patients on the ruxolitinib creams (50.0% on 0.75% and 61.1% on 1.5%) had achieved a at least a 4-point reduction in their itch numerical rating score (NRS) compared with just 27.3% of patients on placebo.

The researchers concluded that the ruxolitinib cream appears to be highly efficacious in patients with more severe AD, which may delay or prevent the need for systemic therapies.

“Although these patients met minimal standard criteria for systemic use, baseline severity in this analysis was lower than the baseline severity in studies with systemic treatments,” they added. “Thus, the data may not be directly comparable.”

In a second poster using the same 2 pooled studies, even patients who did not achieve IGA-TS, defined as a score of 0 or 1 with a ≥ 2-grade improvement from baseline, had clinically relevant improvements when taking ruxolitinib cream.²

A total of 584 patients in the 2 overall studies did not achieve IGA-TS at week 8: 174 patients on placebo, 213 patients on 0.75% ruxolitinib, and 197 patients on 1.5% ruxolitinib. Although they had not achieved IGA-TS, they saw improvements for other end points: EAS-50, ≥ 2-point reduction in itch NRS (NRS2), ≥4-point reduction in Dermatology Life Quality Index (DLQI), ≥6-point reduction in Children’s DLQI (CDLQI), and 1-point reduction in IGA:

• EASI-50: 63.8% of patients on ruxolitinib 0.75%, 65.0% of patients on ruxolitinib 1.5% vs 38.5% on placebo
• NRS2: 42.7% of patients on ruxolitinib 0.75%, 46.2% of patients on ruxolitinib 1.5% vs 27.6% on placebo
• DLQI/CDLQI: 54.0% of patients on ruxolitinib 0.75%, 56.3% of patients on ruxolitinib 1.5% vs 37.4% on placebo
• 1-point reduction in IGA: 71.8% of patients on ruxolitinib 0.75%, 71.1% of patients on ruxolitinib 1.5% vs 43.1% on placebo

In a composite partial response, the proportion of patients who achieved a clinically meaningful response in at least 1 of the above end points were: 88.3% of patients on 0.75% ruxolitinib, 85.3% on 1.5% ruxolitinib, and 63.2% on placebo.

“Importantly, nearly 90% of all patients treated with ruxolitinib cream showed a relevant clinical benefit per reduction in disease severity assessed by IGA at Week 8,” the authors concluded.

References

1. Simpson EL, Kircik L, Bauvelt A, et al. Effects of ruxolitinib cream in patients with atopic dermatitis with baseline body surface area ≥10% and Eczema Area and Severity Index score ≥16: pooled results from two phase 3 studies. Presented at: AAD VMX 2021; April 23-26, 2021. Poster 27620.

2. Simpson EL, Kircik L, Bauvelt A, et al. Efficacy of ruxolitinib cream in patients with atopic dermatitis who demonstrated partial responses: pooled analysis from two randomized phase 3 studies. Presented at: AAD VMX 2021; April 23-26, 2021. Poster 24916.