Ruxolitinib Cream Improves Patient-Reported Outcomes in Atopic Dermatitis

Eric L. Simpson, MD, MCR (OHSU)

Investigative janus kinase (JAK) inhibitor cream therapy ruxolitinib was associated with significant improvement in a series of patient-reported outcomes for the treatment of atopic dermatitis in pooled phase 3 analyses.

In new data presented at the American Academy of Dermatology (AAD) Virtual Meeting Experience this weekend, a multinational team of investigators reported adult and adolescent patients with atopic dermatitis bettered in marks including skin pain numerical rating scale (SPNR) scores and Patient Global Impression of Change (PGIC) when treated with ruxolitinib cream.

Led by Eric L. Simpson, MD, MCR, of Oregon Health & Science University, the investigators observed pooled atopic dermatitis outcomes among ruxolitinib-treated patients in the phase 3 TRuE-AD1 and TRuE-AD2 clinical trials.

Patients included in the pair of studies were aged ≥12 years old, with atopic dermatitis for ≥2. They were additionally required to have an Investigator’s Global Assessment (IGA) score of 2-3, and 3% to 20% of Eczema Area Severity Index (EASI).

“In 2 phase 3 AD studies of identical design, ruxolitinib cream demonstrated anti-inflammatory activity with rapid and sustained antipruritic action vs vehicle and was well tolerated,” investigators wrote.

Simpson and colleagues looked to describe the efficacy of the investigative ruxoloitinib cream on specific patient-reported outcomes in atopic dermatitis care from the 2 trials.

Their assessment included 1249 total patients, 118 of whom were 12-15 years old. Median patient age was 32 years old. Both trials randomized patients 2:2:1 to either 0.75% or 1.5% ruxolitibinib cream, or vehicle cream, each treatment administered twice daily for 8 weeks. The trials were double-blinded.

Investigators observed that ruxolitinib was linked to significant mean patient change from baseline in Patient-Oriented Eczema Measure (POEM) at week 8: -10.5 for 0.75% ruxolitinib; -11.0 for 1.5% ruxolitinib; -4.2 for vehicle (P <.0001).

Dermatology Life Quality Index (DLQI) scores were also significantly improved in both ruxolitinib treatment arms versus placebo: -7.2; -7.1; -3.1, respectively (P <.0001). Children’s DLQI scores similarly improved from baseline to week 8: -5.3; -6.0; -2.3, respectively (P <.01).

SPNR scores were significantly improved in patients within 12 hours of their first application of ruxolitinib (P <.05), and were furthered reduced by week 8: -2.5; -2.6; -1.3, respectively, versus baseline (P <.0001).

Another 80.0% and 84.9% of patients on respective ruxolitinib doses reported much or very much improvement in PGIC scores at week 8, versus 41.3% of patients on vehicle (P <.0001).

The combined trial data showed a good tolerance of ruxolitinib cream among treated patients, with a similar adverse event profile to vehicle. Investigators additionally observed no serious adverse events related to ruxolitinib.

Simpson and colleagues concluded that multiple patient-reported outcomes, at significant rates, were improved in adolescents and adults with atopic dermatitis when treated with investigative ruxolitinib cream.

“Application of ruxolitinib cream resulted in more “clear skin,” less skin pain, and less quality-of-life impairment compared with vehicle,” they wrote.

The study, “Patient-Reported Outcomes of Ruxolitinib Cream for the Treatment of Atopic Dermatitis: Pooled Results From Two Phase 3 Studies,” was presented at AAD VMX.