Background glowZORYVE (roflumilast) cream 0.3%
Background glowZORYVE (roflumilast) cream 0.3%

 LONG-TERM SAFETY

SUSTAINED RESULTS UP TO 64 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.

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 52Week 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 52Week 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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