Asivatrep, a nonsteroidal TRPV1 antagonist, was effective and well tolerated for patients with atopic dermatitis (AD) enrolled in an 8-week, phase 3 double-blind controlled study, according to study data published in the Journal of Allergy and Clinical Immunology.
Investigators recruited patients aged 12 to 70 years with physician-diagnosed AD from 6 hospitals in the Republic of Korea. They included patients with AD affecting 5% to 30% of their body surface area, an Investigator’s Global Assessment (IGA) score of 2 (mild) or 3 (moderate), and those who had applied an emollient at a stable dose at least once daily for at least 7 days before joining the study. Investigators randomly assigned patients 2:1 to receive 1.0% asivatrep or a vehicle cream twice daily for 8 weeks, and conducted clinical and safety assessments at weeks 1, 3, 6 and 8. The primary endpoint was the percentage of patients with an IGA score of 0 or 1 at week 8, and a key secondary endpoint was the percentage of patients with an IGA score of 0 or 1 and a 2-point or greater improvement from baseline at week 8.
In total, 240 patients were included in the study–159 patients in the 1.0% asivatrep group and 81 patients in the vehicle-treated group; 231 patients (153 treated with asivatrep, 78 assigned vehicle) were included in the full analysis due to study discontinuation. The mean age in both groups was about 25 years, and 47% and 44% were women in the vehicle and asivatrep groups, respectively.
The IGA score in the asivatrep group was significantly lower than that of the vehicle-treated group at week 8. The percentage of patients with an IGA score of 0 or 1 was 36% in the asivatrep group vs 12.8% in the vehicle-treated group (P <.001). A greater percentage of patients with an IGA score of 0 or 1 in the asivatrep group had an improvement of at least 2 points from their baseline IGA score (20.3%) compared to the vehicle-treated group (7.7%; P =.01).
The percentage of patients in the asivatrep group with an IGA score of 0 or 1 continued to decrease significantly at week 3, 6 and 8 post-treatment, compared with the vehicle-treated group.
Asivatrep was well tolerated and not associated with clinically significant application-site reactions. The incidence of adverse events was 14.7% in the asivatrep group and 6.3% in the vehicle-treated group; however, this difference was not statistically significant (P =.06), and no adverse events led to discontinuation. Patients did not report any serious adverse reactions, and investigators did not find clinically relevant changes in laboratory parameters, vital signs, electrocardiography results, or physical exams.
The study was limited by the short treatment period, the lack of pediatric patients for analysis, and not evaluating asivatrep with the Dermatology Life Quality Index.
Compared to standard treatment with topical corticosteroid, “asivatrep cream, with its minimal adverse events, can provide a new alternative treatment for adolescents and adults, although long-term safety data have not yet been reported,” the study authors wrote.
Disclosure: Several study author(s) declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of authors’ disclosures.
Park CW, Kim BJ, Lee YW, Won C, Park CO, Chun BY, et al. Asivatrep, a TRPV1 antagonist, for the topical treatment of atopic dermatitis: Phase 3, randomized, vehicle-controlled study (CAPTAIN-AD). Journal of Allergy and Clinical Immunology. Published online October 1, 2021. doi:10.1016/j.jaci.2021.09.024