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Long-term Safety

NO NEW SAFETY SIGNALS WERE REPORTED AND EFFICACY RESULTS WERE CONSISTENT WITH PIVOTAL STUDIES FOR UP TO 64 WEEKS OF TREATMENT10,11

 

Study Design10,11

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 of ZORYVE.

Phase 2b StudyLong-Term Safety StudyVehicle QD12 weeks52 weeksZORYVE (roflumilast) cream 0.15% QDZORYVE (roflumilast) cream0.3% QDN=331Randomized1:1:1Completed Phase 2b Studythrough 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)

 

ZORYVE is tolerable and safe everywhere, for any duration1,2

Most Common Adverse Events (>2%) Reported in Phase 2 Long-Term Safety Study10

Treatment-Emergent Adverse Events, n (%)Overall Total(N=332)URTI/viral URTIUTINasopharyngitisSinusitis/chronic sinusitisArthralgiaBack painCoughHypertension/essential hypertension22 (6.6%)13 (3.9%)13 (3.9%)9 (2.7%)9 (2.7%)8 (2.4%)7 (2.1%)7 (2.1%)
Overall Total(N=332)Treatment-Emergent Adverse Events, n (%)URTI/viral URTIUTINasopharyngitisSinusitis/chronic sinusitisHypertension/essential hypertensionArthralgiaBack painCough22 (6.6%)13 (3.9%)13 (3.9%)9 (2.7%)9 (2.7%)8 (2.4%)7 (2.1%)7 (2.1%)
  • 3.6% of patients experienced a serious adverse event10
  • 97% of adverse events were unrelated or unlikely to be related to treatment; 94% of adverse events were rated mild or moderate10
  • 73.5% of patients completed 52-64 weeks of treatment10
    • 0.9% discontinued due to lack of efficacy
    • 3.9% discontinued due to any adverse event

TEAE = Treatment-Emergent Adverse Events.

URTI = Upper Respiratory Tract Infection.

UTI = Urinary Tract Infection.

 

Sustained efficacy and clearance for a median of 10 months

Clearance (IGA 0 or 1 with any grade improvement) in Phase 2 long-term safety study11

Cohort 2 and VehicleRoflumilast 0.3% (n=168)PERCENTAGE OF PATIENTS48%44%48%41%45%23%39%42%39%45%Roflumilast 0.15% and 0.3%Roflumilast 0.3% (n=164)1005004WEEKS12243652
Cohort 2 and VehicleRoflumilast 0.3% (n=168)PERCENTAGE OF PATIENTSWEEK 4100500WEEK 12WEEK 24WEEK 36WEEK 5223%48%39%44%48%41%45%45%39%42%Roflumilast 0.15% and 0.3%Roflumilast 0.3% (n=164)
  • ~60% of patients achieved IGA of Clear (0) or Almost Clear (1) during the 52-week study (n=185)11*
  • Among these patients, the median duration of maintaining Clear (0) or Almost Clear (1) was 10 months11
  • I-IGA Success was maintained over time10†
  • No tachyphylaxis11

*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).11

†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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