ZORYVE (roflumilast) cream 0.3%
ZORYVE (roflumilast) cream 0.3%

 LONG-TERM SAFETY

SUSTAINED RESULTS UP TO 52 WEEKS

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LONG-TERM SAFETY DATA
LONG-TERM EFFICACY DATA

Study Design6,12

A Phase 2, 52-week open-label, long-term safety study of roflumilast cream 0.3% was conducted with a treatment-naïve cohort (Cohort 2) and a cohort continuing from the Phase 2b study (Cohort 1), regardless of treatment response. For patients that clear, treatment could be stopped and resumed if psoriasis recurred. Patients from Cohort 1 who received vehicle in parent study and rolled over with an IGA of 0/1 were excluded.

Efficacy measures were included as secondary endpoints and the statistics concluded are descriptive. These data are not included in the Prescribing Information for ZORYVE.

12 weeksPhase 2b StudyLong-Term Safety StudyVehicle QD52 weeksZORYVE (roflumilast) cream 0.15% QDZORYVE (roflumilast) cream0.3% QDN=331Randomized1:1:1Completed Phase 2b Study through 12 weeksCOHORT 1 (rollovers)ZORYVE (roflumilast) cream 0.3% QD(n=230)COHORT 2 (naïve)ZORYVE (roflumilast) cream 0.3% QD(n=102)
Vehicle QD12 weeks52 weeksZORYVE (roflumilast) cream 0.15% QDZORYVE (roflumilast) cream 0.3% QDCOHORT 1 (rollovers)ZORYVE (roflumilast) cream 0.3% QD(n=230)COHORT 2 (naïve)ZORYVE (roflumilast) cream 0.3% QD(n=102)N=331Randomized1:1:1Phase 2b StudyLong-Term Safety StudyCompleted Phase 2b Study through12 weeks

Primary
Endpoint

Key Secondary
Endpoints

Occurrence of treatment-emergent adverse events and serious adverse events

IGA of Clear (0) or Almost Clear (1)

I-IGA of Clear (0) or Almost Clear (1)

IGA = Investigator Global Assessment.
I-IGA = Intertriginous Investigator Global Assessment.

Consistently well tolerated and safe for any duration1,5,6

Most Common Adverse Events (>2%) Reported in Phase 2 Long-Term Safety Study6

Treatment-Emergent Adverse Events, n (%)Overall Total(N=332)Viral upper respiratory tract infection/upper respiratory tract infectionNasopharyngitisUrinary tract infectionSinusitis22 (6.6%)12 (3.6%)11 (3.3%)8 (2.4%)
Overall Total(N=332)Treatment-Emergent Adverse Events, n (%)Viral upper respiratory tract infection/upper respiratory tract infectionNasopharyngitisUrinary tract infectionSinusitis22 (6.6%)12 (3.6%)11 (3.3%)8 (2.4%)
  • 3.6% of patients experienced a serious adverse event12
  • 97% of adverse events were unrelated or unlikely to be related to treatment; 94% of adverse events were rated mild or moderate12
  • 73.5% of patients completed 52-64 weeks of treatment12
    • 0.9% discontinued due to lack of efficacy
    • 3.9% discontinued due to any adverse event

Patients maintained Clear or Almost Clear skin for a median of 10 months with continued use, as needed

Clearance (IGA 0 or 1 with any grade improvement) in Phase 2 long-term safety study6

020406080100% OF PATIENTS ACHIEVING IGA OF 0 OR 1ZORYVE 0.15% and 0.3%→ZORYVE 0.3%(n=164)Naïve and vehicle→ZORYVE 0.3%(n=168)Week 12Week 24Week 36Week 42Week 442%39%45%45%41%48%44%39%48%23%
020406080100% OF PATIENTS ACHIEVING IGA OF 0 OR 1ZORYVE 0.15% and 0.3%→ZORYVE 0.3%(n=164)Naïve and vehicle→ZORYVE 0.3%(n=168)Week 12Week 24Week 36Week 42Week 442%39%45%45%41%48%44%39%48%23%
  • ~60% of patients achieved IGA of Clear (0) or Almost Clear (1) during the 52-week study (n=185)6*
  • Among these patients, the median duration of maintaining Clear (0) or Almost Clear (1) was 10 months6
  • I-IGA Success was maintained over time12†
  • No tachyphylaxis6

*Patients who received vehicle in parent Phase 2b study and rolled over into the long-term safety study with an IGA of 0/1 were excluded (n=324).6

†I-IGA was added as study amendment and numbers of patients evaluated are very small at each endpoint. Only Cohort 2 results are provided for I-IGA.

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