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New phase 3 DELTA 1 trial data show the topical pan-JAK inhibitor doubled the rate of treatment success versus vehicle cream.
Topical pan-JAK inhibitor drug candidate delgocitinib cream provided significant improvements across a series of clinical and patient-related outcomes for chronic hand eczema, according to new phase 3 data.1
In findings presented during the late-breaking abstract sessions at the American Academy of Dermatology (AAD) 2023 Annual Meeting in New Orleans this weekend, investigators observed a doubled rate of patients achieving treatment success per Investigators Global Assessment scores (IGA-CHE) with deglocitinib versus vehicle cream at 16 weeks.
Presented by Robert Bissonnette, MD, MSc, from Innodvaderm Research in Montreal, Quebec, the findings may support the regulatory development and possible approval of the LEO Pharma agent to treat the burdensome form of eczema.
Bissonnette and colleagues sought to analyze the efficacy, safety and effect of twice-daily topical 20 mg delgocitinib on health-related quality of life versus vehicle cream in adults with chronic hand eczema. The study follows a phase 2b dose-ranging assessment that showed the agent was associated with significant efficacy and tolerability in adults with mild to moderate disease.
As Bissonnette noted, chronic hand eczema is the most common chronic inflammatory disorder that affects the hands, and is generally linked to pain-related, functional and psychological issues.
“Current treatments for chronic hand eczema, specifically topical treatments, often give rise to unsatisfactory results,” Bissonnette said.
The team randomized adults aged ≥18 years old with moderate to severe chronic hand disease 2:1 to either delgocitinib (n = 325) or cream vehicle (n = 162) for 16 weeks; patients were then enrolled in a 36-week extension trial. They sought a primary end point of IGA-CHE scores of 0 or 1 indicating clear or almost clear hand skin and a ≥2-step improvement per patient at 16 weeks.
Secondary end points included 75% or 90% Hand Eczema Severity Index scores (HECSI-75; HECSI-90) and a Dermatology Life Quality Index (DLQI) score improvement of ≥4 points.
Median patient age was 44.0 years old; 306 (63%) patients were female, and 427 (58%) were White. Median age at chronic hand eczema onset was 32 years old, and baseline IGA-CHE scores were predominately (67%) moderate in severity.
Bissonnette and colleagues reported that a significantly greater rate of patients receiving delgocitinib achieved IGA-CHE treatment success scores versus those receiving vehicle (19.7% vs 9.9%; P = .006). They observed similar rates of success in treatment arm success of HECSI-75 (49.2% vs 23.5%; P <.001) and HECSI-90 (29.5% vs 12.3%; P <.001) versus the vehicle arm.
Patient-reported quality-of-life outcomes per ≥4-point DLQI improvement was additionally significantly greater among the delgocitinib arm versus vehicle (74.4% vs 50.0%; P <.001).
Regarding safety, investigators observed no significant difference in proportion of adverse events among the 2 arms (45.2% vs 50.6%) nor serious adverse events (1.8% vs 1.9%). Relevant to JAK inhibitor marketing labels, investigators observed no major adverse cardiac events.
“Delgocitinib at 20 mg/g provided significant improvement, both in clinician-assessed outcomes like IGA-CHE and HECSI, as well as DLQI, and it was well tolerated over a period of 16 weeks,” Bissonnette concluded.