Biologic License Application STN BL 125036/0: Alefacept for the Treatment of Chronic Plaque Psoriasis

6/4/02


Click here to start


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

Author: CDER USER