Efficacy and Safety of Tacrolimus Ointment Ira D. Lawrence, M.D., F.A.C.P. Senior Vice President Research and Development Fujisawa Healthcare, Inc.

4/23/01


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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%

Author: Research Computing