Table of Contents
Biologic License Application STN BL 125036/0: Alefacept for the Treatment of Chronic Plaque Psoriasis
Indications and Usage
Psoriasis
Psoriasis in Children
Psoriasis: Clinical Significance
Analysis of Clinical Trials
Phase 1 Single-Dose Studies in Healthy Subjects: Results
Phase 1 Studies in Patients with Psoriasis
Analysis of Clinical Trials
Phase 2 and 3 Trials
Primary Efficacy Outcomes
Study C97-708
Study 708
Treatment Response by Dose Group at Post-treatment Week 2
PPT Slide
Mean Total Lymphocyte Count by Dose and Time
Number of Patients with Decreased CD4+ T Cell Counts
Number of Patientsa with Study Drug Substituted by Placebo
DTH Shifts by Dose: Positive to Negative as a Percentage of Subjects Positive at Baseline
DTH Shifts by Dose: Positive to Negative as a Percentage of Subjects Positive at Baseline (cont.)
Study C708: Efficacy Conclusions
Study C708: Effects on Immune Parameters
Study C99-711
Study C99-711: Design
Efficacy Outcomes: First Treatment Course
PASI Score
Observed Mean Changesa in Patient Reported Outcomes
PPT Slide
Number of Treatment Respondersa by Body Weight Quartile
Relation Between Efficacy and CD4
CD4 Counts by Cohort by Course
Subjects with Low CD4+ T Cell Counts at Any Time
Course 1:CD56+ NK Cells
Number of Patientsa with Study Drug Substituted by Placebo
Study C711: Efficacy Conclusions
Study C711: Immunologic Parameters
Study C711: Immunologic Parameters
Study C99-712
Study C712: Design
Efficacy Outcomes
Number of Treatment Respondersa by Body Weight Quartile
Relation Between Efficacy and CD4
Time to Treatment Response
Duration of Treatment Response
Observed Mean Changesa in Patient Reported Outcomes
Subjects with Low CD4+ T Cell Counts at Any Time
Subjects with CD4 and CD8 Cell Count <LLNa on Last Visit
Study C712: Efficacy Conclusions
Study C712: Efficacy Conclusions
Study C712: Safety Conclusions
Integrated Summary of Safety
Toxicology Studies in Cynomolgus Monkeys
Serious Infections in Course 1
Malignancies in Course 1
Incidence During Treatment of Anti-alefacept Antibodies
Overall Conclusions
Alefacept Efficacy
Reduced Lymphocyte Numbers
Reduced Lymphocyte Numbers (cont.d)
Reduced Lymphocyte Numbers (cont.d)
Additional Clinical Data Needed
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