Regardless of Previous Medications, Baseline Characteristics, Ruxolitinib Cream Is Effective in AD

Patients with atopic dermatitis (AD) and a history of previous topical or systemic therapy did well on ruxolitinib cream, according to a poster presented at the American Academy of Dermatology’s annual meeting, held virtually 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 0.75% twice a day, ruxolitinib 1.5% twice a day, or placebo cream twice a day. Patients who were on the ruxolitinib cream continued treatment for 44 weeks while patients who were initially randomized to the placebo were rerandomized 1:1 to either of the ruxolitinib creams.

The majority (80%) of patients in the study had previously taken a topical corticosteroid (TCS). Less than one-fourth (22.1%) previously took a topical calcineurin inhibitor (TCI) and 18.9% previously took a systemic therapy. Only 10.8% had no previous treatment and 20.0% reported no previous TCS.

At 8 weeks, patients who received the ruxolitinib creams were more likely than those who received placebo to achieve Investigator’s Global Assessment treatment success (IGA-TS), a ≥ 75% improvement in Eczema Area and Severity Index (EASI-75) from baseline, and a ≥ 4-point improvement in itch numerical rating scale score from baseline (NRS4).

• IGA-TS achieved: 11.5% on placebo vs 44.7% on ruxolitinib 0.75% and 52.6% on ruxolitinib 1.5%
• EASI-75 achieved: 19.7% on placebo vs 53.8% on ruxolitinib 0.75% and 62.0% on ruxolitinib 1.5%
• Itch NRS4 achieved: 15.8% on placebo vs 0.75% on ruxolitinib 0.75% and 51.5% on ruxolitinib 1.5%

Patients who took a previous TCI, TCS, or systemic therapy had better responses than those with no previous treatment or previous TCS.

“Ruxolitinib cream demonstrated a high level of efficacy in patients with AD regardless of previous use of topical or systemic therapy,” the authors concluded.

A second poster assessed the efficacy by baseline IGA score (2 or 3), EASI score (≤ 7 or > 7), itch numerical rating score (< 4 or ≥ 4), and affected body surface area (BSA) score (<10% or ≥ 10%).² This poster included the same population from the first poster. Baseline demographics and clinical characteristics were similar across the 3 groups.

At 8 weeks:

1. 11.5% of patients on placebo, 44.7% of patients on ruxolitinib 0.75%, and 52.6% on ruxolitinib 1.5% achieved IGA-TS
2. 38.9% on placebo, 72.5% on ruxolitinib 0.75%, and 78.8% on ruxolitinib 1.5% achieved a 50% improvement in EASI
3. 19.7% on placebo, 53.8% on ruxolitinib 0.75%, and 62.0% on ruxolitinib 1.5% achieved EASI-75
4. 7.0% on placebo, 36.6% on ruxolitinib 0.75%, and 43.9% on ruxolitinib 1.5% achieved a 90% improvement in EASI
5. 15.8% on placebo, 41.5% on ruxolitinib 0.75%, and 51.5% on ruxolitinib 1.5% achieved itch NRS4

Across all end points, responses for patients on ruxolitinib 1.5% were better if they had an IGA score of 3, EASI score of > 7, itch score ≥ 4, or BSA ≥ 10% at baseline.

“Ruxolitinib cream has the potential to be an effective treatment for AD irrespective of patients’ pretreatment characteristics, with higher responses observed in patients with more severe disease,” the authors concluded.

References

1. Bauvelt A, Eichenfield LF, Kuligowski ME, et al. Efficacy of ruxolitinib cream among patients with atopic dermatitis based on previous medication history: pooled results from two phase 3 studies. Presented at: AAD VMX 2021; April 23-26, 2021. Poster 27482.

2. Papp K, Szepietowski JC, Kircik L, et al. Efficacy of ruxolitinib cream among patients with atopic dermatitis by baseline clinical characteristics: pooled subgroup analysis from two randomized phase 3 studies. Presented at: AAD VMX 2021; April 23-26, 2021. Poster 27716.