Fully 82.8% of adult patients using VTAMA achieved an Intertriginous Physician Global Assessment Score of clear or almost clear from baseline at Week 12.
VTAMA (tapinarof) Cream, 1% performed well in intertriginous plaque psoriasis(iPsO), according tonew Phase 4 data presented at the 43rdAnnual Fall Clinical Dermatology Conference in Las Vegas.
This Phase 4 study expands the body of data for VTAMA cream in adult plaque psoriasis. In the two 12-week Phase 3 pivotal studies (PSOARING 1 and 2; n=1025), VTAMA cream had previously demonstrated a Physician Global Assessment (PGA) success rate*of 36% and 40% for adult patients with plaque psoriasis vs. 6% and 6% for patients on vehicle, respectively.
DMVT-505-4001 was a Phase 4, open-label multi-center study that evaluated the efficacy and safety of VTAMA cream, 1% in adults with iPsO. The trial enrolled 34 participants with mild, moderate, and severe iPsO (iPGA score ≥2) aged 18 years or older at 7 sites across the U.S. Patients received VTAMA cream once daily for 12 weeks with a follow up one week after study completion. Safety and tolerability were assessed based on adverse events and local tolerability scores using the investigator-assessed Local Tolerability Scale (LTS) of intertriginous areas.
The primary endpoint of the study was the proportion of patients who achieved an iPGA score of 0 (clear) or 1 (almost clear) and ≥2-grade improvement from baseline at Week 12. The secondary endpoint of the study was the time to achieve an iPGA score of 0 or 1 and ≥2-grade improvement from baseline. Key exploratory endpoints of the study included: change in itch as assessed by change in Peak Pruritus-Numeric Rating Scale (PP-NRS) (intertriginous areas) score over time; achievement of ≥4-point reduction in PP-NRS (intertriginous areas) over time; and change in Dermatology Life Quality Index (DLQI) over time.
VTAMA cream demonstrated compelling efficacy for the treatment of iPsO, including in patients with genital involvement (n=3), with 82.8% of adult patients (n=29) achieving an iPGA Score of 0 (clear) or 1 (almost clear) and ≥2-grade improvement from baseline at Week 12, the primary endpoint of the study.
Moreover, VTAMA cream showed a rapid onset of efficacy with iPGA success achieved as early as Week 2 and with a median time to iPGA success of 6 weeks, the secondary endpoint of the study.
At Week 12, 65.5% of participants achieved complete disease clearance (iPGA=0), with a median time to complete disease clearance of 8 weeks. Onset of itch relief was apparent by Week 1 and increased over time with 50% of patients achieving a clinically meaningful>4-point improvement in PP-NRS at Week 4 and 75% at Week 12, by the end of the study.
Substantial and clinically meaningful improvement in quality of life, as indicated by a 4-point improvement in DLQI, was achieved by Week 2 with further improvement out to Week 12.
VTAMA cream was well tolerated with no new safety signals. The most common adverse reactions in the Phase 4 trial were consistent with the Phase 3 most common adverse reactions. In the two Phase 3 pivotal trials, the most common adverse reactions (incidence ≥ 1%) in subjects treated with VTAMA cream were folliculitis, nasopharyngitis, contact dermatitis, headache, pruritus, and influenza.
“The results of this Phase 4 study are meaningful because patients that entered this study had suffered with extensive disease, many over ten years duration. While the rates of disease clearance are impressive, the fast onset of VTAMA cream and associated itch relief are particularly noteworthy,” says study author Howard Sofen, MD, of Dermatology Research Associates in Los Angeles, CA, in a news release. “These data, combined with those of previous studies, further indicate that VTAMA cream is a safe and effective treatment for adult patients with intertriginous plaque psoriasis.”
“Intertriginous plaque psoriasis can be a challenging disease, especially with limited treatment options appropriate for long term use and which may cause potential adverse effects. The data we are sharing today brings an innovative, safe, and effective steroid-free prescription topical treatment to those suffering from, and indeed hardest hit by, this debilitating condition,” adds Todd Zavodnick, Chief Executive Officer of Dermavant. “Disease improvement is an expectation of psoriasis patients, and we are able to point to meaningful levels of complete disease clearance in highly sensitive intertriginous areas, as this study shows.”
“We are thrilled to share the positive data from our Phase 4 clinical trial of VTAMA cream for the treatment of intertriginous plaque psoriasis in adult patients,” says Philip M. Brown, MD, JD, Chief Medical Officer at Dermavant. “The results demonstrate that VTAMA cream is efficacious, safe and well tolerated for the treatment of plaque psoriasis in sensitive intertriginous areas, which are consistent with and build upon results from our PSOARING Phase 3 pivotal clinical trials. This Phase 4 trial of VTAMA cream has demonstrated the ability to not only safely address the visible lesions, but also to improve the quality of life because the plaques improved.”
