PGA treatment success: PGA score of 0 or 1 and ≥2-grade improvement from baseline to week 12 (ITT, MI)1-3
Up to 40% of adult patients with plaque psoriasis who received VTAMA achieved PGA treatment success§ vs vehicle (36% and 40% vs 6% and 6% in PSOARING 1 and PSOARING 2, respectively) at Week 12, with significant results as early as Week 4.2,3
PGA, Physician Global Assessment.
§PGA treatment success defined as PGA score of clear or almost clear (0 or 1) and ≥2-grade improvement from baseline to Week 12.
PASI75 from baseline to Week 12 (ITT, MI)1,4
VTAMA cream delivered significant PASI75 rates as early as Week 4, and at Week 12, up to 48% of adult patients achieved PASI75 vs ~10% of those using vehicle.1,4,¶
ITT, intention-to-treat; MI, multiple imputation; PASI75, ≥75% improvement in Psoriasis Area and Severity Index; PGA, Physician Global Assessment.
¶No conclusions of efficacy should be made based on the exploratory endpoints (Week 2, 4, and 8).
Itch significantly improved as early as Week 2, and this improvement was maintained through Week 12, with up to ~68% of adult patients with plaque psoriasis treated with VTAMA achieving a minimum 4-point improvement in PP-NRS** scores vs 46% on vehicle at Week 12.5,††
ITT, intention-to-treat; OC, observed cases; PP-NRS, Peak Pruritus-Numeric Rating Scale.
**PP-NRS, a patient self-reported item, is an 11-point scale ranging from “no itch” (0) to “worst itch possible” (10), designed to assess worst itch experienced in a 24-hour period. No conclusions of efficacy should be made based on this associated efficacy endpoint (minimum 4-point improvement in PP-NRS at Weeks 2, 4, 8, 12).6††In those patients with at least a 4-point PP-NRS score at baseline.6
‡‡Denotes statistical significance.6
Adverse Reactions Occurring in ≥1% of Patients in the 12-Week PSOARING 1 and PSOARING 2 Clinical Trials
See the significant results from some adult patients in the VTAMA pivotal studies. Please note that the scores reflect a global assessment of the patient's plaque psoriasis, whereas the images are only representative of one lesion or body area. Individual results may vary.
Age: 56 Gender: Female Patient: 1017-010
Primary Endpoint Success7,*
Baseline
Week 4
Week 12
Age: 26 Gender: Male Patient: 2903-005
Primary Endpoint Failure7,*
Baseline
Week 4
Week 12
Age: 67 Gender: Male Patient: 2030-001
Primary Endpoint Failure7,*
Baseline
Week 4
Week 12
Age: 48 Gender: Male Patient: 1015-007
Primary Endpoint Success7,*
Baseline
Week 4
Week 12
Age: 63 Gender: Male Patient: 2014-011
Primary Endpoint Success7,*
Baseline
Week 4
Week 12
Age: 67 Gender: Male Patient: 2030-001
Primary Endpoint Failure7,*
Baseline
Week 4
Week 12
Age: 28 Gender: Male Patient: 1010-017
Primary Endpoint Success7,*
Baseline
Week 8
Week 12
DLQI, Dermatology Life Quality Index; PASI, Psoriasis Area and Severity Index; PGA, Physician Global Assessment; PP-NRS, Patient-Reported Peak Pruritus Numeric Rating Scale.
*Primary endpoint success refers to the primary study endpoint of a patient achieving a PGA score of 0 or 1 and ≥2-grade improvement from baseline at week 12.2
†PGA and PASI are global efficacy assessments. Example of 1 representative target lesion of 1 VTAMA cream–treated patient from the PSOARING clinical studies. Individual results may vary.2
‡PASI was measured as a secondary endpoint.2
§DLQI and PP-NRS are Patient-Reported Outcomes.2
DLQI, Dermatology Life Quality Index; PASI, Psoriasis Area and Severity Index; PGA, Physician Global Assessment; PP-NRS, Patient-Reported Peak Pruritus Numeric Rating Scale.
*Primary endpoint success refers to the primary study endpoint of a patient achieving a PGA score of 0 or 1 and ≥2-grade improvement from baseline at week 12.2
†PGA and PASI are global efficacy assessments. Example of 1 representative target lesion of 1 VTAMA–treated patient from the PSOARING clinical studies. Individual results may vary.2
‡PASI was measured as a secondary endpoint.2
§DLQI and PP-NRS are Patient-Reported Outcomes.2
DLQI, Dermatology Life Quality Index; PASI, Psoriasis Area and Severity Index; PGA, Physician Global Assessment; PP-NRS, Patient-Reported Peak Pruritus Numeric Rating Scale.
*Primary endpoint success refers to the primary study endpoint of a patient achieving a PGA score of 0 or 1 and ≥2-grade improvement from baseline at week 12.2
†PGA and PASI are global efficacy assessments. Example of 1 representative target lesion of 1 VTAMA cream–treated patient from the PSOARING clinical studies. Individual results may vary.2
‡PASI was measured as a secondary endpoint.2
§DLQI and PP-NRS are Patient-Reported Outcomes.2
DLQI, Dermatology Life Quality Index; PASI, Psoriasis Area and Severity Index; PGA, Physician Global Assessment; PP-NRS, Patient-Reported Peak Pruritus Numeric Rating Scale.
*Primary endpoint success refers to the primary study endpoint of a patient achieving a PGA score of 0 or 1 and ≥2-grade improvement from baseline at week 12.2
†PGA and PASI are global efficacy assessments. Example of 1 representative target lesion of 1 VTAMA cream–treated patient from the PSOARING clinical studies. Individual results may vary.2
‡PASI was measured as a secondary endpoint.2
§DLQI and PP-NRS are Patient-Reported Outcomes.2
DLQI, Dermatology Life Quality Index; PASI, Psoriasis Area and Severity Index; PGA, Physician Global Assessment; PP-NRS, Patient-Reported Peak Pruritus Numeric Rating Scale.
*Primary endpoint success refers to the primary study endpoint of a patient achieving a PGA score of 0 or 1 and ≥2-grade improvement from baseline at week 12.2
†PGA and PASI are global efficacy assessments. Example of 1 representative target lesion of 1 VTAMA cream–treated patient from the PSOARING clinical studies. Individual results may vary.2
‡PASI was measured as a secondary endpoint.2
§DLQI and PP-NRS are Patient-Reported Outcomes.2
DLQI, Dermatology Life Quality Index; PASI, Psoriasis Area and Severity Index; PGA, Physician Global Assessment; PP-NRS, Patient-Reported Peak Pruritus Numeric Rating Scale.
*Primary endpoint success refers to the primary study endpoint of a patient achieving a PGA score of 0 or 1 and ≥2-grade improvement from baseline at week 12.2
†PGA and PASI are global efficacy assessments. Example of 1 representative target lesion of 1 VTAMA cream–treated patient from the PSOARING clinical studies. Individual results may vary.2
‡PASI was measured as a secondary endpoint.2
§DLQI and PP-NRS are Patient-Reported Outcomes.2
DLQI, Dermatology Life Quality Index; PASI, Psoriasis Area and Severity Index; PGA, Physician Global Assessment; PP-NRS, Patient-Reported Peak Pruritus Numeric Rating Scale.
*Primary endpoint success refers to the primary study endpoint of a patient achieving a PGA score of 0 or 1 and ≥2-grade improvement from baseline at week 12.2
†PGA and PASI are global efficacy assessments. Example of 1 representative target lesion of 1 VTAMA cream–treated patient from the PSOARING clinical studies. Individual results may vary.2
‡PASI was measured as a secondary endpoint.2
§DLQI and PP-NRS are Patient-Reported Outcomes.2
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No thanks, take me to the healthcare professionals VTAMA cream website for adults with plaque psoriasis.
No thanks,
take me to the healthcare professionals VTAMA cream
website for adults with
plaque psoriasis.
IMPORTANT SAFETY INFORMATION
Indications: VTAMA® (tapinarof) cream, 1% is an aryl hydrocarbon
receptor agonist indicated for:
Adverse Events: In plaque psoriasis, the most common adverse reactions (incidence ≥1%) were: red raised bumps around the hair pores (folliculitis), pain or swelling in the nose and throat (nasopharyngitis), skin rash or irritation, including itching and redness, peeling, burning, or stinging (contact dermatitis), headache, itching (pruritus), and flu (influenza).
Adverse Events: In atopic dermatitis, the most common adverse reactions (incidence ≥1%) were: upper respiratory tract infection, red raised bumps around the hair pores (folliculitis), lower respiratory tract infection, headache, asthma, vomiting, ear infection, pain in extremity, and stomach-area (abdominal) pain.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
Robert, 36
Not an actual patient
Your adventurous patient
• Concerned about plaque psoriasis flare-ups limiting his active
lifestyle. During a flare-up, his affected BSA can go up to 5% and his PGA score is 3
(moderate)
• Wants something to help keep his psoriasis plaques clearer so
he doesn’t have to worry about them
Previous
Emily, 51
Not an actual patient
Your active and public‑facing patient
• Works in a public-facing job and is self-conscious about her
appearance when having a plaque psoriasis flare
• Has mild plaque psoriasis and is not a candidate for
biologics
• Cycled through different over-the-counter steroid creams, which
did not give her the results she was looking for
• Does a lot of research but relies on her dermatologist for her
best options
Previous
Carlos, 55
Not an actual patient
Your patient with sensitive skin
• Has an affected BSA of 10%, and psoriasis plaques are
concentrated in sensitive areas
• Has psoriasis plaques on sensitive areas of his body, including
his genitals, causing embarrassment
• Felt topical corticosteroids were not the right option for him
due to his treatment area
• Wants to get back to socializing and dating without worrying
about psoriasis plaques
Previous
