INTRODUCTORY REMARKS

4/19/01


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Table of Contents

INTRODUCTORY REMARKS

CHALLENGES IN STUDY OF DRUG EFFECTS IN LUPUS

LUPUS TRIALS

SLE Disease Activity Index SLEDAI

SLEDAI Components / Weights

Systemic Lupus Activity Measure: SLAM

SLAM Components by System

British Isles Lupus Assessment Group: BILAG

European Consensus Lupus Activity Measure: ECLAM

Performance Characteristics (“Validation”)

Recent trials in mild-moderate lupus (not lupus nephritis)

Other DHEA RCTs in lupus

Early Discussions

MEDICAL REVIEW

Outline

Design: Trial 94-01

Design: Trial 94-01

Design: Trial 94-01

Patients: Trial 94-01

Withdrawals: Trial 94-01 Survival analyses

Efficacy results: Trial 94-01

SLEDAIɮ subset: Trial 94-01 (Hypothesis generating)

SLEDAIɮ subset: Trial 94-01

SLEDAI categories: Trial 94-01 ENDPOINT= % responders

SLEDAI Categories: Trial 94-01 ENDPOINT= mean % change of prednisone from baseline

Design: Trial 95-02

Endpoints: Trial 95-02

Design: Trial 95-02

Statistical Analysis Plan Trial 95-02

Patients: Trial 95-02

Withdrawals: Trial 95-02 Survival analyses

Efficacy results: Trial 95-02

Efficacy results: Trial 95-02

SLEDAIɮ Patients (n=293) Trial 95-02

SLEDAIɮ + Rxɮmo Patients (n=265) Trial 95-02

Same subset (SLEDɮ, rxɮmo) Using modified window (n=265) Trial 95-02

Summary: Responder Analyses Trial 95-02

Safety- general

Adverse Events with pɘ.05 Trial 94-01

Adverse Events with pɘ.05* Trial 95-02

OUTSTANDING ISSUES REGARDING THE WEIGHT OF THE EVIDENCE

EXTRA SLIDES

SLEDAI Categories: Trial 95-02

KJ extra: Risk / benefit

KJ extra: Moving forward

KJ extra: Moving forward - caution

KJ extra: Additional RCTs - preparatory

KJ extra: Lupus RCTs - intrinsic problems

Author: CDER USER