Table of Contents
Efficacy and Safety of Tacrolimus Ointment Ira D. Lawrence, M.D., F.A.C.P. Senior Vice President Research and Development Fujisawa Healthcare, Inc.
Five Core Phase III Studies
Five Core Phase III Studies
12W, DB Studies - Adult (35/36) / Pediatric (37) Controlled Study Design
12W, DB Studies - Adult (35/36) / Pediatric (37) Eligibility Criteria
Results
12W, DB Studies - Adult (35/36) / Pediatric (37) Combined Patient Disposition
12W, DB Studies - Adult (35/36) / Pediatric (37) Combined Patient Demographics
12W, DB Studies - Adult (35/36) / Pediatric (37) Combined Baseline Disease Characteristics
12W, DB Studies - Adult (35/36) / Pediatric (37) Combined Baseline Disease Characteristics
PPT Slide
12W, DB Studies - Adult (35/36) / Pediatric (37) Primary Efficacy Endpoint
12W, DB Studies - Adult (35/36) / Pediatric (37) Analyses Performed for Success
12W, DB Studies - Adult (35/36) / Pediatric (37) Analyses Performed for Success
12W, DB Studies - Adult (35/36) / Pediatric (37) Success (ᢒ% improvement)
12W, DB Studies - Adult (35/36) / Pediatric (37) Combined Success (ᢒ% improvement)
12W, DB Studies - Adult (35/36) / Pediatric (37) > 50% Improvement
12W, DB Studies - Adult (35/36) / Pediatric (37) > 50% Improvement at Week 1 and End of Treatment (EOT)
Efficacy Confirmation: Secondary Endpoints
Comparison of 0.1% versus 0.03% Tacrolimus Ointment
12W, DB Studies - Adult (35/36) / Pediatric (37) Success (ᢒ% improvement)
12W, DB Studies - Adult (35/36) Success in Adults by Concentration by Baseline Disease Severity
12W, DB Studies - Adult (35/36) Success in Adults by Concentration by %BSA Affected at Baseline
12W, DB Studies - Adult (35/36) Success in Adults
Efficacy Summary
PPT Slide
Five Core Phase III Studies
12W, DB Studies - Adult (35/36) / Pediatric (37) Combined Median Treatment Days
12W, DB Studies - Adult (35/36) / Pediatric (37) Combined Adverse Events Adjusted Incidence Rates ‡
Comparison of Active and Vehicle Using 95% Confidence Interval
12W, DB Studies - Adult (35/36) / Pediatric (37) Combined Common Adverse Events (> 5%) ‡ Treatment Difference with 95% CI
12W, DB Studies - Adult (35/36) / Pediatric (37) Combined Skin Burning Prevalence
12W, DB Studies - Adult (35/36) / Pediatric (37) Adverse Events of Clinical Interest Adjusted Incidence Rates ‡
12W, DB Studies - Adult (35/36) / Pediatric (37) Cutaneous Events of Clinical Interest Adjusted Incidence Rates ‡
12W, DB Studies - Pediatric (37) Common Adverse Events in Children‡ Treatment Difference with 95% CI
12W, DB Studies - Pediatric (37) Common Adverse Events in Children‡ Treatment Difference with 95% CI
12W, DB Studies - Pediatric (37) Adverse Event of Clinical Interest in Children Adjusted Incidence Rates ‡
12W, DB Studies - Pediatric (37) Adverse Event Profile in Young Pediatric Patients -- Age 2-6 (n=215)
12W, DB Studies - Adult (35/36) / Pediatric (37) Combined 0.1% minus 0.03% with 95% CI Common Adverse Events‡
12W, DB Studies - Adult (35/36) / Pediatric (37) Adverse Events Summary
Open-Label Studies Adult (FG-12) / Pediatric (25)
OL Studies - Adult (FG-12) / Pediatric (25) Summary of Raw Incidence of Adverse Events
OL Studies - Adult (FG-12) / Pediatric (25) Common (ᡂ%) Application Site Events*
OL Studies - Adult (FG-12) / Pediatric (25) Common (ᡂ%) Non-Application Site Adverse Events
OL Studies - Adult (FG-12) / Pediatric (25) Non-Application Site Adverse Events
Open-Label Safety Studies
Five Core Studies Hazard Rates
Five Core Studies Daily Hazard Rates+ (SE) Over Time 0.1% Tacrolimus Ointment
OL Study – Pediatric (25) Lymphadenopathy Hazard Rates+ (SE) Over Time 0.1% Tacrolimus Ointment - Pediatrics
COSTART Code “Lymphadenopathy”
Lymphoma
Five Core Studies Clinical Laboratory Evaluation
Safety Summary - Tacrolimus Ointment 0.03% & 0.1% Concentrations
Safety Summary - Tacrolimus Ointment 0.03% & 0.1% Concentrations
Advisory Committee Questions
Advisory Committee Questions
Advisory Committee Questions
Advisory Committee Questions
Advisory Committee Questions
Advisory Committee Questions
Advisory Committee Questions
Advisory Committee Questions
Advisory Committee Questions
Tacrolimus Ointment Further Recommendations
Tacrolimus Ointment 0.03%, 0.1%
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