Interim analysis suggest the JAK inhibitor may become a breakthrough treatment for chronic hand dermatitis—a condition currently without a marketed drug.
Ruxolitinib cream 1.5% was significantly efficacious in treating chronic hand dermatitis over 4 weeks, according to new findings that may indicate breakthrough potential for the topical Janus kinase (JAK) inhibitor in a patient population currently without marketed treatment options.1
In late-breaking data presented at the Revolutionizing Atopic Dermatitis (RAD) 2023 Spring Conference in Washington, DC, this weekend, investigators from the University of Rochester Medical Center’s department of dermatology reported significant improvements in skin clearance, itch relief and quality of life among patients with chronic hand disease who received ruxolitinib cream 1.5%.
The 4-week interim analysis from an ongoing 12-week study funded by Incyte could support the progression of ruxolitinib cream toward a US Food and Drug Administration (FDA) application as the potentially first drug indicated to treat chronic hand disease.
Presented by Hannah D. Smith, BA, a medical student with the University of Rochester School of Medicine, the interim analysis sought to address chronic hand disease—a uniquely presenting and burdensome condition across individual patients—with a broadly efficacious topical agent in ruxolitinib cream 1.5%.
“It’s a very heterogenous disorder with multiple etiologies and morphologies such as irritant contact dermatitis, allergic contact dermatitis, atopic dermatitis, hyperkeratotic hand eczema, dyshidrotic hand eczema, and so on,” Smith said. “The lifetime prevalence of chronic hand eczema is 14.5%, and the prevalence is about 3-4 times higher in patients with atopic dermatitis.”
What’s more, approximately three-fourths of patients with the condition suffer from low measures of quality of life (QoL), Smith noted; current strategies for treatment are less successful and dissatisfactory for patients and clinicians alike.
The proof-of-concept, open-label assessment included 14 patients from the Rochester department with moderate to severe recalcitrant chronic hand dermatitis per Investigators Global Assessment (IGA) scores ≥2. Smith and colleagues assessed ruxolitnib cream 1.5% efficacy per IGA, Hand Eczema Severity Index (HESCI), Numerical Rating Scale (NRS) and Dermatology Life Quality Index (DLQI) improvement.
Patients underwent treatment and screening following a washout period, receiving twice-daily ruxolitinib cream 1.5%.
At 4 weeks, the treatment was associated with significant clinical improvements. All patients achieved HESCI-50; two thirds (64%) achieved HESCI-75 (P <.001).
Another 79% of patients achieved a ≥2-point reduction in baseline IGA. A similar rate (71%) achieved a ≥2-point improvement in 24-hour itch score per NRS; another 57% had a ≥4-point improvement (P <.001). Every treated patient reported an improvement in DLQI from baseline to 4 weeks (P <.01).
Investigators additionally observed no treatment-related adverse events, nor any need for rescue medication among patients receiving ruxolitinib cream 1.5%.
Smith and colleagues concluded from their interim analysis that ruxolitinib cream 1.5% may provide efficacious and tolerable benefit for moderate to severe chronic hand dermatitis—as well as significant benefit to QoL—as assessments continue.
“The trial is ongoing to evaluate these outcomes at 12 weeks, and we have our last pariticpant finishing treatment at the end of May,” Smith said. “This is the first study evaluating the efficacy of ruxolitinib cream on chronic hand dermatitis—as far as we know—and reveals a breakthrough therapeutic for a challenging disease.”