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
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