Ruxolitinib cream is both safe and effective as a potential treatment for adolescents and adults with atopic dermatitis, according to study results presented at the American Academy of Dermatology’s Virtual Meeting Experience (AAD VMX) 2021, held online from April 23 to April 25, 2021.
Using pooled data from 2 phase 3 studies (TRuE-AD1 and TRuE-AD2; ClinicalTrials.gov identifiers NCT03745638 and NCT03745651), researchers sought to evaluate the efficacy of ruxolitinib cream based on baseline characteristics in both adult and adolescent patients with atopic dermatitis.
Both studies had identical designs. Patients were randomly assigned 2:2:1 to 1 of 2 ruxolitinib cream regimens: 0.75% twice daily or 1.5% twice daily, or vehicle cream twice daily for 8 weeks of double-blind treatment. Participants assigned to the ruxolitinib groups continued treatment for an additional 44 weeks, and participants who received the vehicle cream were reassigned 1:1 to a treatment regimen.
Eligible participants were at least 12 years old with a diagnosis of atopic dermatitis for 2 years or longer. Participants had an Investigator’s Global Assessment (IGA) score of 2 or 3, and 3% to 20% affected body surface area.
Researchers evaluated treatment efficacy via baseline IGA score, Eczema Area Severity Index (EASI) score (≤7 or >7), itch numerical rating scale (NRS) score (<4 or ≥4), and body surface area (<10% or ≥10%). Week 8 efficacy endpoints included the proportion of patients who achieved IGA treatment success (IGA-TS score of 0 or 1 with a ≥2-grade improvement), of 50% or greater, 75% of greater, and 90% or greater improvement in EASI score vs baseline, and a 4-point or greater improvement in itch NRS score from baseline.
The total cohort included 1249 adolescent and adult patients (median age, 32 years), and distribution of demographics and clinical characteristics were similar across treatment groups at baseline.
Investigators found that at week 8, patients had greater clinical response rates using both strengths of ruxolitinib cream than the vehicle groups — regardless of clinical subgroup characteristics when assessed by any measurement scale. Response rates for ruxolitinib cream 1.5% across all efficacy endpoints were “generally greater” at week 8 for patients with a baseline IGA score of 3, an EASI score greater than 7, itch NRS score of 4 or higher, or BSA 10% or greater.
Safety outcomes demonstrated that ruxolitinib cream was well tolerated and had a similar adverse event profile as the vehicle. No serious adverse events were reported in the treatment groups.
“Ruxolitinib cream demonstrated superior efficacy vs vehicle in all analyzed endpoints,” the researchers concluded. “Ruxolitinib…has the potential to be an effective treatment for [atopic dermatitis] irrespective of patients’ pretreatment characteristics, with higher responses observed in patients with more severe disease.”
Disclosure: Several study authors declared affiliations with the pharmaceutical industry. Please see the original reference for a full list of authors’ disclosures.
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Papp K, Szepietowski JC, Kircik L, et al. Efficacy of ruxolitinib cream for the treatment of atopic dermatitis by baseline clinical characteristics: pooled subgroup analysis from two randomized phase 3 studies. Presented at: AAD VMX 2001; April 23-25, 2021. Abstract/Poster 27716.