Table of Contents
Agenda
Efficacy Overview
Randomized Placebo-Controlled Studies
Phase 2 Dose-Ranging, Randomized,Placebo-Controlled Study
Phase 2 Summary
Phase 3 Studies
Phase 3: Psoriasis Disease Status at Baseline
PASI: Psoriasis Area and Severity Index
Phase 3 Endpoints
Determination of Response Rate:2 Weeks After Last Dose vs. Overall
PASI 50
PASI 75
Phase 3 IM Study
Phase 3 IM study design
Phase 3 IM Primary Endpoint: PASI 75, 2 Weeks After Last Dose
Phase 3 IMPGA “Almost Clear/Clear”, 2 Weeks After Last Dose
Phase 3 IMPASI 50, 2 Weeks After Last Dose
Phase 3 IM PASI 75, 2 Weeks vs. Overall Response Rate
Phase 3 IV Study
Phase 3 IV Study Design
Phase 3 IV StudyEfficacy, 2 weeks after last dose
Phase 3 IV StudyEfficacy, Overall Response Rates
Phase 3 IV Duration of Efficacy
PPT Slide
Quality of Life
PPT Slide
PPT Slide
PPT Slide
Efficacy in Sub-populations
PPT Slide
PPT Slide
Efficacy Conclusions
Pharmacodynamics
Overview of Pharmacodynamics
Lymphocyte Populations
Mean Memory and Naïve T Cells, Course 1 of Phase 3 IV Study
Mean CD4+ T Cell CountCourse 1 of Phase 3 IV Study
Mean Total Lymphocyte Count from Course 1 of Phase 3 IV study
Mean CD4+ T Cell CountCourses 1 and 2 of Phase 3 IV Study
PPT Slide
Return of CD4+ T Cell Counts to Normal RangePhase 3 IV Study, Cohort 2
Monitoring Alefacept Therapy
Lymphocyte PD: Implications
Infections and CD4+ T Cell Counts in Placebo-Controlled Studies
Immune Function Tests in Alefacept-treated Patients
Primary and Secondary AntibodyResponses to Neoantigen (?X174)
Relationship Between CD4+ Memory T Cell Effects and PASI 75, Overall Response Rate
Relationship Between T-Cell Counts in Skin Lesions and Disease Activity*
Lymphocyte PD: Conclusions
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