Biologic License Application: anakinra (KINERET) for rheumatoid arthritis

8/20/01


Click here to start


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

Author: siegelj