Vtama Drug Information
Generic name: TAPINAROF
Aryl Hydrocarbon Receptor Agonist [EPC]
Uses of Vtama
Plaque Psoriasis VTAMA ® cream is indicated for the topical treatment of plaque psoriasis in adults.
Atopic Dermatitis
VTAMA cream is indicated for the topical treatment of atopic dermatitis in adults and pediatric patients 2 years of age and older.
Dosage & Administration of Vtama
Apply a thin layer of VTAMA cream to affected areas once daily. Wash hands after application, unless VTAMA cream is for treatment of the hands. VTAMA cream is not for oral, ophthalmic, or intravaginal use.
Side Effects of Vtama
Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Plaque Psoriasis Clinical Trials In two randomized, double-blind, multicenter, vehicle-controlled clinical trials (PSOARING 1 and PSOARING 2), 1025 adults with plaque psoriasis were treated with VTAMA cream or received vehicle cream once daily for up to 12 weeks. Subjects ranged in age from 18 to 75 years, with an overall median age of 51 years.
The majority of subjects were White (85%) and male (57%); and 85% identified as non-Hispanic or Latino. Table 1 presents adverse reactions that occurred in at least 1% of subjects treated with VTAMA cream, and for which the rate exceeded the rate for vehicle. Adverse reactions leading to treatment discontinuation in >1% of subjects who received VTAMA cream were contact dermatitis (2.9%) and folliculitis (2.8%).
Atopic Dermatitis Clinical Trials In two randomized, double-blind, multicenter, vehicle-controlled clinical trials (ADORING 1 and ADORING 2), 811 adult and pediatric subjects 2 years of age and older with atopic dermatitis were treated with VTAMA cream or received vehicle cream once daily for up to 8 weeks. Subjects ranged in age from 2 to 81 years, with an overall median age of 11 years. The adverse reactions observed in pediatric subjects 2 years of age and older were generally consistent with those observed in adults with atopic dermatitis.
The safety profile with long term use was generally consistent with the safety profile observed at Week 8.
| Adverse Reaction | VTAMA cream N=683 n (%) | Vehicle cream N=342 n (%) |
|---|---|---|
| Folliculitis Folliculitis includes application site folliculitis and folliculitis | 140 (20) | 3 (1) |
| Nasopharyngitis Nasopharyngitis includes nasopharyngitis, nasal congestion, pharyngitis, respiratory tract infection (RTI) viral, rhinorrhea, sinus congestion, upper RTI, and viral upper RTI | 73 (11) | 31 (9) |
| Contact dermatitis Contact dermatitis includes dermatitis, contact dermatitis, hand dermatitis, and rash | 45 (7) | 2 (1) |
| Headache Headache includes headache, migraine, and tension headache | 26 (4) | 5 (1) |
| Pruritus Pruritus includes application site pruritus, pruritus, generalized pruritus, and genital pruritus | 20 (3) | 2 (1) |
| Influenza Influenza includes influenza and influenza-like illness | 14 (2) | 2 (1) |
| Adverse Reaction | VTAMA cream N=541 n (%) | Vehicle cream N=270 n (%) |
|---|---|---|
| Upper respiratory tract infection Upper respiratory tract infection includes upper respiratory tract infection, nasopharyngitis, nasal congestion, sinusitis, pharyngitis streptococcal, cough, oropharyngeal pain, pharyngitis, acute sinusitis, streptococcal infection, streptococcus test positive, viral upper respiratory tract infection, viral infection, rhinorrhea, sinus congestion | 66 (12) | 15 (6) |
| Folliculitis Folliculitis includes folliculitis, application site folliculitis, keratosis pilaris, follicular eczema | 51 (9) | 3 (1) |
| Lower respiratory tract infection Lower respiratory tract infection includes lower respiratory tract infection, COVID-19, influenza, bronchitis, pneumonia | 25 (5) | 6 (2) |
| Headache | 23 (4) | 3 (1) |
| Asthma Asthma includes asthma, wheezing | 12 (2) | 1 (0) |
| Vomiting | 10 (2) | 2 (1) |
| Ear infection Ear infection includes ear infection, otitis media, otitis externa, otitis media acute | 10 (2) | 1 (0) |
| Pain in extremity Pain in extremity includes pain in extremity, arthralgia | 9 (2) | 1 (0) |
| Abdominal pain Abdominal pain includes abdominal pain and abdominal pain upper | 6 (1) | 0 (0) |
Pregnancy Safety for Vtama
Pregnancy Risk Summary The available data on VTAMA cream use in pregnant women are insufficient to evaluate for a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes. In animal reproduction studies, subcutaneous administration of tapinarof to pregnant rats and rabbits during the period of organogenesis resulted in no significant adverse effects at doses 264 and 16 times, respectively, the maximum recommended human dose (MRHD) ( see Data ). The estimated background risk of major birth defects and miscarriage for the indicated population is unknown.
All pregnancies have a background risk of major birth defects, loss, and other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. Data Animal Data In an embryofetal development study in rats, tapinarof was administered by subcutaneous injection to pregnant animals at doses of 1.2, 6.9 and 34 mg/kg/day during the period of organogenesis.
Tapinarof was not associated with embryofetal lethality or fetal malformations. Tapinarof increased the incidence of skeletal variations (incomplete ossification of nasal bones) at the dose of 34 mg/kg/day (264 times the MRHD based on AUC comparisons). In an embryofetal development study in rabbits, tapinarof was administered by subcutaneous injection to pregnant animals twice daily at doses of 0.3, 1, and 3 mg/kg/day during the period of organogenesis.
Maternal toxicity as evidenced by decreased maternal body weight gain and associated increased post-implantation loss (embryolethality) was observed at 3 mg/kg/day. In addition, fetal skeletal variations were observed at 3 mg/kg/day. In a second embryofetal development study in rabbits, tapinarof was administered by continuous subcutaneous infusion to pregnant animals at doses of 1, 2 and 3 mg/kg/day during the period of organogenesis.
Maternal toxicity associated with decreases in body weight gain and food consumption was noted at 30 mg/kg/day (264 times the MRHD based on AUC comparisons). Tapinarof decreased fetal survival and viability that resulted in reduced litter sizes and decreased fetal weights at doses greater than or equal to 6 mg/kg/day (44 times the MRHD based on AUC comparisons). No tapinarof-related effects on fetal survival and viability were noted at a dose of 1 mg/kg/day (6 times the MRHD based on AUC comparisons).
No tapinarof-related effects on postnatal development, neurobehavioral or reproductive performance of offspring were noted at doses up to 30 mg/kg/day (264 times the MRHD based on AUC comparison).
Pediatric Use of Vtama
Pediatric Use Plaque Psoriasis The safety and efficacy of VTAMA cream for the topical treatment of plaque psoriasis have not been established in pediatric patients. Atopic Dermatitis The safety and efficacy of VTAMA cream for the topical treatment of atopic dermatitis have been established in pediatric patients 2 years of age and older. Use of VTAMA cream for this indication is supported by evidence from two adequate and well-controlled trials (ADORING 1 and ADORING 2), which included 654 pediatric subjects 2 years of age and older (436 of whom received VTAMA cream) with moderate to severe atopic dermatitis.
Adverse reactions occurring more frequently in pediatric subjects compared to adults were upper respiratory tract infection and ear infection. The dose escalation conducted at PND 22 was implemented to maintain consistent systemic exposure across the duration of the dosing period. Renal pelvic dilatation was observed at doses greater than or equal to 15 mg/kg/day (165 times the MRHD based on AUC comparisons).
No adverse effects in juvenile animals were noted at 1.5 mg/kg/day (11 times the MRHD based on AUC comparisons).
Clinical Studies of Vtama
Plaque Psoriasis
Two multicenter, randomized, double-blind, vehicle-controlled trials were conducted to evaluate the safety and efficacy of VTAMA cream for the treatment of adults with plaque psoriasis (PSOARING 1 and PSOARING 2 ). These trials were conducted in a total of 1025 subjects randomized 2:1 to VTAMA cream or vehicle cream applied once daily for 12 weeks to any lesion regardless of anatomic location. Baseline disease severity was graded using the 5-point Physician’s Global Assessment (PGA).
The majority of subjects had “Moderate” disease (82%), while 10% had “Mild” disease, and 8% had “Severe” disease at baseline. The extent of disease involvement assessed by mean body surface area (BSA), excluding the scalp, palms, and soles, was 8% (range 3 to 20%). Subjects ranged in age from 18 to 75 years, with a median age of 51 years.
Overall, 57% of the subjects were male and 85% were White. The primary efficacy endpoint in both studies was the proportion of subjects who achieved treatment success, defined as a PGA score of “Clear” or “Almost Clear” and at least a 2-grade improvement from baseline. Efficacy results from the two trials are summarized in Table 4.
These subjects were followed for up to 40 additional weeks with a median time to first worsening (PGA ≥ 2 ) of Atopic Dermatitis Two multicenter, randomized, double-blind, vehicle-controlled trials were conducted to evaluate the safety and efficacy of VTAMA cream for the treatment of adult and pediatric subjects 2 years of age and older with atopic dermatitis (ADORING 1 and ADORING 2 ). Baseline disease severity was graded using the 5-point validated Investigator’s Global Assessment (vIGA-AD™). The majority of subjects had “Moderate” disease (87%), while 13% had “Severe” disease at baseline.
The extent of disease involvement assessed by mean affected BSA, excluding the scalp, was 16.8% (range 5 to 44%). The mean baseline Eczema Area and Severity Index (EASI) score was 12.9 (range 4.4 to 36.0). The mean baseline Peak Pruritus Numeric Rating Scale (PP-NRS) score for subjects 12 years of age and older was 6.4 on a scale of 0-10.
Subjects ranged in age from 2 to 81 years, with a median age of 11 years. For ethnicity, 78% of subjects identified as non-Hispanic or Latino. Efficacy was also assessed using a ≥ 4-point improvement in PP-NRS score in subjects 12 years of age and older.
These subjects were followed for up to 48 additional weeks with a median time to first worsening (vIGA-AD ≥ 2 ) of
| Clinical Response | PSOARING 1 | PSOARING 2 | ||
|---|---|---|---|---|
| VTAMA cream N=340 | Vehicle cream N=170 | VTAMA cream N=343 | Vehicle cream N=172 | |
| PGA Treatment Success Treatment success was defined as a PGA score of “Clear” or “Almost Clear” and at least a 2-grade improvement from baseline. | 36% | 6% | 40% | 6% |
| Difference (95% CI) | 29% (22%, 36%) | 34% (27%, 41%) | ||
| ADORING 1 | ADORING 2 | |||
|---|---|---|---|---|
| VTAMA cream | Vehicle cream | VTAMA cream | Vehicle cream | |
| Number of subjects randomized | 270 | 137 | 271 | 135 |
| vIGA-AD Treatment Success Based on number of subjects randomized., Treatment success was defined as a vIGA-AD score of “Clear” or “Almost Clear” and at least a 2-grade improvement from baseline. Difference from Vehicle (95% CI) | 45% 32% (23%, 40%) | 14% | 46% 29% (19%, 38%) | 18% |
| Number of subjects ≥12 years of age with baseline PP-NRS score ≥4 | 103 | 54 | 126 | 64 |
| ≥ 4-point improvement in PP-NRS Based on number of subjects 12 years of age and older whose baseline PP-NRS score was ≥4. Difference from Vehicle (95% CI) | 56% 22% (5%, 38%) | 34% | 53% 29% (15%, 43%) | 24% |
Drug information sourced from the FDA. This content is for informational purposes only and does not constitute medical advice. Consult a healthcare professional before making any medication decisions.
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