Pivotal Safety
CONSISTENTLY WELL TOLERATED AND SAFE
Pivotal Safety
SAFE FOR ANY LOCATION1
- Low rates of stinging or burning (1.6%)2*
- Not associated with folliculitis, atrophy, striae, or HPA-axis suppression1
- Low rate of discontinuation due to adverse events (1.6%)1
HPA = hypothalamic-pituitary-adrenal.
| Adverse reactions reported in ≥1% of patients aged 6+ treated with ZORYVE cream 0.15% for 4 weeks† | ZORYVE (n=885) | Vehicle (n=451) |
|---|---|---|
| Headache | 26 (2.9%) | 4 (0.9%) |
| Nausea | 17 (1.9%) | 2 (0.4%) |
| Application Site Pain | 13 (1.5%) | 3 (0.7%) |
| Diarrhea | 13 (1.5%) | 2 (0.4%) |
| Vomiting | 13 (1.5%) | 2 (0.4%) |
Insomnia was reported in fewer than 1% of patients treated with ZORYVE.
*Low rates of hot, tingling/stinging sensation reported in patient-rated tolerability assessments 10–15 minutes after first application: 1.6% with ZORYVE (n=883) vs 2.0% with vehicle (n=451).
†Based on pooled safety data from INTEGUMENT-1 and INTEGUMENT-2.
Long-term Safety
DEMONSTRATED SAFETY AND EFFICACY
UP TO 56 WEEKS3
Study Design1,3
Starting at Week 4 of the open-label extension, 20% (n=130) of patients who achieved vIGA-AD of Clear (vIGA-AD=0) switched to a twice-weekly application. If signs or symptoms were not adequately controlled or vIGA-AD ≥2, patients switched back to ZORYVE once daily.
PRIMARY ENDPOINT
Occurrence of treatment-emergent adverse events and serious adverse events
KEY SECONDARY ENDPOINTS
EASI-75
Safety and tolerability
Efficacy measures were secondary endpoints - all outcomes are reported as observed. These data are not in the Prescribing Information for ZORYVE.
Long-term Safety Data
Demonstrated long-term safety
and tolerability in an open-label extension study3
Most common adverse events (≥2%) reported in patients aged 6+ treated with ZORYVE cream 0.15%
| Treatment-Emergent Adverse Events, n (%) | Overall (N=657) |
|---|---|
| COVID-19 | 4.6% |
| Upper respiratory tract infection | 3.2% |
| Nasopharyngitis | 3.0% |
| Headache | 2.7% |
No new safety
signals identified
Long-term Efficacy Data
Sustained results up to 56 weeks
in an open-label extension study3
Patients aged 6+ achieving EASI-75 increased through Week 56
Pooled EASI-75 response rates for rollover patients from INTEGUMENT-1, INTEGUMENT-2, and patients from a vehicle-only cohort. EASI response rates are defined as percentage of patients with improved EASI scores from baseline to Week 56. EASI scores evaluate the following atopic dermatitis symptoms: erythema, skin thickness (induration, papulation, swelling), excoriations, lichenification, and percentage of region affected. EASI-75=75% reduction in EASI score from baseline. These efficacy data are secondary outcomes of the open-label extension trial and are not in the Prescribing Information for ZORYVE.