Pivotal Safety
CONSISTENTLY WELL TOLERATED AND SAFE
Pivotal Safety
SAFE FOR ANY LOCATION1, 4
- Low rates of stinging or burning (<1.0%)5*
- Not associated with folliculitis, atrophy, striae, or HPA-axis suppression4
- Low rate of discontinuation due to adverse events (1.1%)4
HPA = hypothalamic-pituitary-adrenal.
| Adverse reactions reported in ≥1% of patients aged 2–5 treated with ZORYVE cream 0.05% for 4 weeks | ZORYVE (n=437) | Vehicle (n=215) |
|---|---|---|
| Upper respiratory tract infection | 18 (4.1%) | 3 (1.4%) |
| Diarrhea | 11 (2.5%) | 1 (0.5%) |
| Vomiting | 9 (2.1%) | 0 (0%) |
| Rhinitis | 7 (1.6%) | 0 (0%) |
| Conjunctivitis | 6 (1.4%) | 0 (0%) |
| Headache | 5 (1.1%) | 0 (0%) |
*Low rates of hot, stinging/burning sensation reported in caregiver-rated tolerability assessments 10–15 minutes after first application: 0.5% with ZORYVE (n=437) vs 2.8% with vehicle (n=214).
Long-term Safety
DEMONSTRATED SAFETY AND EFFICACY
UP TO 56 WEEKS
Study Design1,6
Starting at Week 4 of the open-label extension, 30% (n=170) 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.
Patients who 'aged up' from 5 to 6 years during the study were to be switched to ZORYVE cream 0.15% at their first scheduled visit after their birthday.
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 study6
Most common adverse events (≥4%) reported in patients aged 2–5 treated with ZORYVE cream 0.05%
| Treatment-Emergent Adverse Events, n (%) | Overall (N=562) |
|---|---|
| Upper respiratory tract infection | 8.7% |
| Nasopharyngitis | 5.0% |
| Pyrexia | 5.0% |
| Influenza | 3.9% |
The safety profile
was generally consistent
with the safety profile from
INTEGUMENT-PED1
Long-term Efficacy Data
Sustained results up to 56 weeks
in an open-label extension study6
Patients aged 2–5 achieving EASI-75 increased through Week 56
EASI-75 for rollover patients from INTEGUMENT-PED, regardless of treatment response, 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.