Significantly clearer skin for up to 52 Weeks
41% of patients entered with or achieved completely clear skin at least once in the open-label long-term extension (LTE) study3
PSOARING 3:
Proven Safety and Sustained Efficacy
PSOARING 3 was an open-label, LTE study designed to evaluate safety, durability of response, and duration of remittive effect (median time to PGA≥2 from PGA=0) of VTAMA cream in adult patients with plaque psoriasis over 40 weeks.2,26
Remittive effect is continued efficacy and lasting results in adult patients with plaque psoriasis even when off-treatment as demonstrated in the 40-week, open-label, LTE.2,5-7,26
At the end of the 12-week pivotal studies, 763 adult patients (92% of eligible patients) rolled over to the open-label, LTE study26
Clearer Skin in the Open-Label LTE Study
Disease Clearance and Disease Control of Plaque Psoriasis Demonstrated26-28
40.9% of adult patients (n=312/763) entered with or achieved complete disease clearance at least once in the open-label LTE study.*26,27
71.2% of adult patients (n=543/763) entered with or achieved PGA=0 or 1 at least once in the open-label LTE study.†28
*Including patients who entered with PGA=0 (n=79) and patients entering with PGA≥1 who achieved PGA=0 at least once during the open-label LTE study (n=233).26,27
†Including patients who entered with PGA=0 or 1 (n=240) and patients entering with PGA≥2 who achieved PGA=0 or 1 at least once during the open-label LTE study (n=303).28
Efficacy even when off treatment
Adult patients who achieved clear skin (PGA=0) during the open-label LTE study (n=312), maintained a mean total duration of disease control (PGA=0 or 1) off therapy of 130 days26
Before and After Images
See the significant results from some adult patients using VTAMA cream in the LTE study. VTAMA cream helped adult patients with mild, moderate, and severe plaque psoriasis achieve clearer skin. Please note that the photographs you will see are representative of one target lesion on individual patients treated with VTAMA cream during this study.
Torso
Age: 41 Gender: Female Patient: 1015-001
Primary Endpoint Success9
Baseline
Physicians Rated
PGA=4
PASI*=19.8
PASI*=19.8
Patient Rated
DLQI†=6
PP-NRS‡=10
PP-NRS‡=10
Week 12
Physicians Rated
PGA=1
PASI*=3.8
PASI*=3.8
Patient Rated
DLQI†=0
PP-NRS‡=0
PP-NRS‡=0
Week 36 (Open-label LTE study week 24)
Off-treatment
Physicians Rated
PGA=1
PASI*=1.2
PASI*=1.2
Patient Rated
DLQI†=0
Week 40 (Open-label LTE study week 28)
Off-treatment
Physicians Rated
PGA=1
PASI*=1.2
PASI*=1.2
Patient Rated
DLQI†=0
Week 48 (Open-label LTE study week 36)
Off-treatment
Physicians Rated
PGA=2
PASI*=5.4
PASI*=5.4
Patient Rated
DLQI†=2
Week 52 (Open-label LTE study week 40)
On-treatment
Physicians Rated
PGA=3
PASI*=5.4
PASI*=5.4
Patient Rated
DLQI†=3
Age: 41 Gender: Female Patient: 1015-001
Primary Endpoint Success9
Baseline
Physicians Rated
PGA=4
PASI*=19.8
PASI*=19.8
Patient Rated
DLQI†=6
PP-NRS‡=10
PP-NRS‡=10
Week 12
Physicians Rated
PGA=1
PASI*=3.8
PASI*=3.8
Patient Rated
DLQI†=0
PP-NRS‡=0
PP-NRS‡=0
Week 36 (Open-label LTE study week 24)
Off-treatment
Physicians Rated
PGA=1
PASI*=1.2
PASI*=1.2
Patient Rated
DLQI†=0
Week 40 (Open-label LTE study week 28)
Off-treatment
Physicians Rated
PGA=1
PASI*=1.2
PASI*=1.2
Patient Rated
DLQI†=0
Week 48 (Open-label LTE study week 36)
Off-treatment
Physicians Rated
PGA=2
PASI*=5.4
PASI*=5.4
Patient Rated
DLQI†=2
Week 52 (Open-label LTE study week 40)
On-treatment
Physicians Rated
PGA=3
PASI*=5.4
PASI*=5.4
Patient Rated
DLQI†=3
DLQI, Dermatology Life Quality Index; PASI, Psoriasis Area and Severity Index; PGA, Physician Global Assessment; PP-NRS, Patient-Reported Peak Pruritus Numeric Rating Scale.
*PASI was measured as a secondary endpoint.
†DLQI and Peak Pruritus numeric rating scale (PP-NRS) were Patient-Reported Outcomes. PP-NRS is a singled, patient self-reported item.
§PP-NRS is a single, patient self-reported item. It is an 11-point scale ranging from "no itch" (0) to "worse itch possible" (10), to assessed worst itch experience in a 24-hour period.
Favorable and consistent safety profile seen in an open-label, LTE study26,27
Treatment-emergent adverse events of special interest in the open-label, LTE study27
- In a 40-week, open-label, LTE study, VTAMA cream demonstrated a favorable safety profile26
- The rates of folliculitis and contact dermatitis were consistent with the pivotal studies26
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