Table of Contents
Biologic License Application: anakinra (KINERET) for rheumatoid arthritis
Anakinra: Proposed Indication
Anakinra: Background
Background (cont.)
Kineret BLA
Trials of Anakinra
Study 990145
990145: Study Design
990145: Study Conduct
990145: Baseline Disease Activity
990145: Disease Activity (cont.)
990145: ACR Responses
990145: Time Course
990145: ACR Components
990145: Subset Analysis
990145: Subset by Age
990145: Subset by RF Status
990145: Subset by ESR
Additional Efficacy Trials
Studies 560 & 960180
Study 560: Patient Population
560: Clinical Responses
Study 960180
960180: Clinical Responses
960180: Sustained Responses
Signs & Symptoms: Summary
Radiographic Progression: RA Guidance Document
560: Radiographic Assessment
560: Larsen Scores
FDA Analysis of Larsen Scores, Non-Parametric Analysis
560: Sharp Scores
Radiographic Assessments: Summary
Safety: Overall Exposure
560 & 960180: Deaths and SAEs
990145: Deaths and SAEs
Abnormal Lab Values
Leukopenia
AEs Occurring at a Higher Frequency with Anakinra
990757: Randomized Safety Study
990757: Study Design
990757: Patient Population
990757: Study conduct
990757: Deaths and SAEs
990757: Serious Infections
Serious Infections
Serious Infections: Risk Factors
Study 2000125 (0125): Enbrel Combination
Study 0125
0125: Lab Abnormalities
Leukopenia and Serious Infections
Serious Infections in Anakinra Trials
Summary: Etanercept Combination Study
Summary of Safety
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