Safety
Well tolerated and
safe for any
body location1-3
ZORYVE is for topical use only and not for ophthalmic, oral, or intravaginal use1,2
ZORYVE is for topical use only and not for ophthalmic, oral, or intravaginal use1,2
Pivotal Safety
SAFE FOR ANY LOCATION
IN DERMIS-1 AND DERMIS-2:
Low rates of stinging or burning (0.4%)3*
Not associated with folliculitis, atrophy, striae, or HPA-axis suppression2
Low rate of discontinuation due to adverse events (1%)2
*Low rates of hot, tingling/stinging sensation reported in patient-rated tolerability assessments 10–15 minutes after first application: 0.4% for ZORYVE cream (n=562) vs 0.0% for vehicle (n=301).
| Adverse reactions reported in ≥1% of patients treated with ZORYVE cream for 8 weeks2 | ZORYVE (N=576) | Vehicle (N=305) |
|---|---|---|
| Diarrhea | 3.1% | 0.0% |
| Headache | 2.4% | 1.0% |
| Insomnia | 1.4% | 0.7% |
| Nausea | 1.2% | 0.3% |
| Application site pain | 1.0% | 0.3% |
| Upper respiratory tract infection | 1.0% | 0.3% |
| Urinary tract infection | 1.0% | 0.7% |
Seventeen of 18 patients experienced mild diarrhea. Most patients reported cases in the first 2 weeks and resolved with continued dosing. No patients discontinued or interrupted treatment due to diarrhea.4
Based on pooled safety data from DERMIS-1 and DERMIS-2.
In an open label study, the adverse reaction profile in pediatric subjects aged 2 to 5 was consistent with that observed in adults and pediatric subjects 6 years of age and older.1†
†A Phase 3, 24-week open label long term safety study of ZORYVE cream 0.3% applied once daily was conducted in patients aged 2 to 5 with plaque psoriasis (N=21). For patients whose psoriatic plaques resolved, treatment could be stopped and resumed if plaque psoriasis recurred. Primary endpoint was occurrence of AEs and SAEs.
Long-term Safety
DEMONSTRATED SAFETY AND EFFICACY UP TO 64 WEEKS
STUDY DESIGN5
Primary Endpoint
Occurrence of treatment-emergent adverse events (AEs) and serious adverse events (SAEs)5
KEY SECONDARY ENDPOINTS
IGA of Clear (0) or Almost Clear (1)5
I-IGA of Clear (0) or Almost Clear (1)5
Long-term Safety Data
Demonstrated long-term safety and tolerability in an open-label extension study5
Most Common Adverse Events (>2%) Reported in Patients Treated with ZORYVE Cream for up to 64 Weeks
| Treatment-Emergent Adverse Events, n (%) | Overall (N=332) |
|---|---|
| Viral upper respiratory tract infection / upper respiratory tract infection | 22 (6.6%) |
| Nasopharyngitis | 12 (3.6%) |
| Urinary tract infection | 11 (3.3%) |
| Sinusitis | 8 (2.4%) |
No new safety signals reported
Results were consistent with DERMIS Phase 3 OLE and pivotal studies‡
3.6% of patients experienced a serious adverse event5
97% of adverse events were unrelated or unlikely to be related to treatment;
94% of adverse events were rated mild or moderate5
73.5% of patients completed the 52-week trial5
- 0.9% discontinued due to lack of efficacy
- 3.9% discontinued due to any adverse event
‡A Phase 3, 24-week open label long term safety study of ZORYVE cream 0.3% applied once daily was conducted in patients 2 to 5 years of age with plaque psoriasis (N=21). For patients whose psoriatic plaques resolved, treatment could be stopped and resumed if plaque psoriasis recurred. Primary endpoint was occurrence of AEs and SAEs.4
Long-term Efficacy Data
Sustained results up to 64 weeks in an open-label extension study5
Patients maintained IGA of Clear or Almost Clear for a median of 10 months (n=185)5§
Intertriginous IGA Success (0/1 and at least a 2-grade improvement) was maintained over time5||
No tachyphylaxis5
§Analysis of the 57% of patients (n=185) who achieved Clear (0) or Almost Clear (1) skin during the trial.
||Patients from Cohort 1 who received vehicle in parent study and rolled over with an IGA of 0/1 were excluded.