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Drug Trials Snapshots: VTAMA

HOW TO USE THIS SNAPSHOT
The information provided in Snapshots highlights who participated in the key clinical trials that supported the original FDA approval of this drug, and whether there were differences among sex, race, age, and ethnic groups. The “MORE INFO” bar shows more detailed, technical content for each section. The Snapshot is intended as one tool for consumers to use when discussing the risks and benefits of the drugs.

LIMITATIONS OF THIS SNAPSHOT
Do not rely on Snapshots to make decisions regarding medical care. Always speak to your healthcare provider about the benefits and risks of a drug.

Some of the information in this Snapshot is for presentation purposes and does not represent the approved conditions of use of this drug. Refer to the VTAMA Prescribing Information for all of the approved conditions of use of this drug (e.g., indication(s), population(s), dosing regimen(s), safety information).

Snapshots are limited to the information available at the time of the original approval of the drug and do not provide information on who participated in clinical trials that supported later approvals for additional uses of the drug (if applicable).

VTAMA (tapinarof)
(vee-TAM-uh)
Dermavant Sciences Inc.
Approval date: May 23, 2022


DRUG TRIALS SNAPSHOT SUMMARY:

What is the drug for?

VTAMA is a small molecule aryl hydrocarbon receptor (AhR) modulating agent that is indicated for the topical treatment of plaque psoriasis in patients 18 years of age and older.

How is this drug used?

VTAMA is a topical cream that is applied to affected areas once daily.

Who participated in the clinical trials?

The FDA approved VTAMA based on evidence (efficacy and safety) from two clinical trials of 1,025 patients with plaque psoriasis. The trials were conducted at 97 sites in the United States and Canada.

How were the trials designed?

The efficacy and safety of VTAMA were evaluated in two clinical trials (DMVT-505-3001 and DMVT-505-3002) of adult patients with stable plaque psoriasis. Both trials were multicenter, randomized, double-blind, vehicle-controlled trials. In both trials, patients applied the drug once daily to affected areas for 12 weeks. The benefit of VTAMA to vehicle was assessed after 12 weeks of treatment using the Physician’s Global Assessment (PGA) score that measures the severity of disease on a scale from 0 to 4 for both trials.

Because plaque psoriasis is a chronic disease, long-term data is necessary to assess the safety and efficacy. After completing the initial 12-week daily phase, patients could voluntarily continue in an open-label, long-term extension study (DMVT-505-3003) for up to an additional 40 weeks.


DEMOGRAPHICS SNAPSHOT

Figure 1. Baseline Demographics by Sex

Pie chart summarizing how many male and female patients were in the clinical trial. In total, 589 (57%) male patients and 436 (43%) female patients participated in the clinical trial.

Source: Adapted from FDA Review

Figure 2. Baseline Demographics by Race

Pie chart summarizing how many White, Black or African American, Asian, and other patients were in the clinical trial. In total, 870 (85%) White patients, 47 (4%) Black or African American patients, 71 (7%) Asian patients, and 37 (4%) Other patients participated in the clinical trial.

Adapted from FDA Review

Figure 3. Baseline Demographics by Age

Pie chart summarizing how many patients by age were in the clinical trial. In total, 886 (86%) patients younger than 65 years of age and 139 (14%) patients 65 years of age and older participated in the clinical trial.

Source: Adapted from FDA Review

Figure 4. Baseline Demographics by Ethnicity

 

Pie chart summarizing how many Hispanic, Not Hispanic, and other patients were in the clinical trial. In total, 153 (14.9%) Hispanic or Latino patients, 867 (84.6%) Not Hispanic or Latino patients, and 5 (0.5%) Other patients participated in the clinical trial.


Source: Adapted from FDA Review

What are the benefits of this drug?

In two trials, more patients with plaque psoriasis achieved clear or almost clear skin after 12 weeks of treatment with VTAMA in comparison to those who were treated with placebo. In Trial DMVT-505-3001, 35% of patients treated with VTAMA achieved clear or almost clear skin compared to 6% of patients treated with placebo. In Trial DMVT-505-3002, 40% of patients treated with VTAMA achieved clear or almost clear skin compared to 6% of patients treated with placebo.

Were there any differences in how well the drug worked in clinical trials among sex, race, and age?

  • Sex: VTAMA worked similarly in males and females.
  • Race: The number of patients of races other than White was limited; therefore, differences in response among races could not be determined.
  • Age: The number of patients older than 65 years of age was limited; therefore, differences in response between patients younger and older than 65 years of age could not be determined.

What are the possible side effects?

The most common side effects of VTAMA include inflamed hair pores (folliculitis); the common cold, sore throat, and sinus infection (nasopharyngitis); local skin irritation (contact dermatitis); headache; itchiness (pruritus); and influenza.

Were there any differences in side effects among sex, race and age?

  • Sex: Folliculitis and pruritus were more likely to occur in males compared to females. Nasopharyngitis, contact dermatitis, and headache were slightly more common in females.
  • Race: Asians were more likely to develop folliculitis and pruritus than Whites or Blacks. However, the majority of patients were White; therefore, no definitive conclusions across races can be drawn.
  • Age: Subjects aged 66 and older were more likely to experience contact dermatitis and pruritus than younger subjects.

GLOSSARY

CLINICAL TRIAL: Voluntary research studies conducted in people and designed to answer specific questions about the safety or effectiveness of drugs, vaccines, other therapies, or new ways of using existing treatments.
COMPARATOR: A previously available treatment or placebo used in clinical trials that is compared to the actual drug being tested.
EFFICACY: How well the drug achieves the desired response when it is taken as described in a controlled clinical setting, such as during a clinical trial.
PLACEBO: An inactive substance or “sugar pill” that looks the same as, and is given the same way as, an active drug or treatment being tested. The effects of the active drug or treatment are compared to the effects of the placebo.
SUBGROUP: A subset of the population studied in a clinical trial. Demographic subsets include sex, race, and age groups.

PRESCRIBING INFORMATION

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