Asivatrep cream reduces itching, appearance of atopic dermatitis
Treatment with asivatrep provided significant and sustained relief of atopic dermatitis symptoms, including pruritus, in both adolescents and adults, according to data published in The Journal of Allergy and Clinical Immunology.
Chun Wook Park, MD, PhD, professor in the department of dermatology at Kangnum Sacred Heart Hospital, Hallym University College of Medicine in Seoul, South Korea, and colleagues wrote that although there are FDA-approved topical therapies for atopic dermatitis, more effective and safe options are needed for long-term management.
“Atopic dermatitis (AD) is a chronic inflammatory pruritic skin disease that flares periodically and has a high prevalence of approximately 25% in children and 10% in adults, although it depends on the countries surveyed,” Park and colleagues wrote. “Both genetic and environmental factors have been implicated as risk factors for the progression of AD.”
Park and colleagues designed a phase 3, randomized, double-blind study that included 240 patients aged 12 to 70 years with mild to moderate AD to evaluate the efficacy of 1% asivatrep cream (PAC-14028, AmorePacific), a novel TRPV1 antagonist.
Researchers randomly assigned patients 2:1 to twice daily treatment with asivatrep cream (n = 159; mean age, 26 years; 43.8% female) or a vehicle cream (n = 81; mean age, 25.3 years; 47.4% female). Most patients in the treatment (88.7%) and vehicle groups (84%) completed the study.
Results were assessed at baseline and at weeks 1, 3, 6 and 8. Achieving a clear (score of 0) to almost clear (score of 1) Investigator Global Assessment (IGA) score at week 8 served as the study’s primary outcome. Secondary endpoints included patients who achieved an IGA score of clear or almost clear with a 2-point improvement from baseline to week 8, and changes in scores for Eczema Area and Severity Index (EASI), pruritis VAS and sleep disturbance.
At week 8, a greater proportion of the treatment group achieved a clear to almost clear IGA score compared with the vehicle group (36% vs. 12.8%; P < .001). Additionally, a greater proportion of patients in the treatment group had had an IGA score of 0 or 1 and an improvement of at least 2 points from baseline compared with the vehicle group (20.3% vs. 7.7%; P = .01).
The treatment group experienced a mean 44.3% reduction in the EASI score compared with 21.4% for the vehicle group at week 8 (P < .001), and significantly more patients treated with asivatrep saw 50% (50.3% vs. 28.2%; P = .001), 75% (23.5% vs. 11.5%; P = .03) and 90% (9.8% vs. 2.6%; P = .046) EASI improvements compared with the vehicle group.
Patient-reported itch was lower in the treatment group compared with the vehicle group at week 1, which was maintained until week 8 (P = .018). Similarly, patients in the treatment group reported a greater reduction in sleep disturbance caused by itching at weeks 3, 6 and 8 compared with those in the vehicle group.
At week 8, patients in the treatment group reported greater reductions of mean pruritis VAS scores compared with the vehicle group (2.3 ± 2.4 vs. 1.5 ± 2.4; P = .018).
Asivatrep cream was well-tolerated and not associated with any clinically significant application site reactions.
The researchers noted that although the incidence of treatment-related adverse events was higher in the treatment group (14.7% vs 6.3%), treated patients reported that events were generally mild in severity. Also, all events recovered or stabilized during the treatment period, and most were unrelated to asivatrep.
Park and colleagues also addressed a few limitations, including the short treatment and follow-up period, the lack of children aged 11 years or younger, and the sample size limited to Korean patients.