バイオマーカーは狼瘡市場を変えることができるか

Abstract

Introduction

The identification of valid biomarkers for systemic lupus erythematosus (SLE) will be an important aid to companies developing drugs for SLE and may speed drug development in this market. Although no biomarkers are yet accepted and routinely used for any aspect of SLE, several promising SLE biomarkers are under investigation. Get the Answers You Need to Shape Your Strategy

Biomarkers have the potential to play a valuable role in drug development for SLE. What impact would biomarkers have on SLE clinical trials? How could biomarkers help reduce the cost of developing SLE treatments? Which types of companies will see the greatest impact from the use of biomarkers?

Biomarkers have tremendous potential in guiding treatment for SLE. How could biomarkers help guide physicians in their prescribing decisions? What role would diagnostic biomarkers and disease-activity biomarkers play? Many types of biomarkers are being developed, including genetic markers, markers of disease activity, and diagnostic markers. Which type of markers are likely to have the greatest nearterm impact for drug development? Which markers are the most promising? A prognostic biomarker of disease activity could lower treatment costs in SLE. How would biomarkers help reduce direct SLE costs? Indirect SLE costs?

Scope

An introduction to SLE: disease definition, epidemiology, and pathophysiology.

Biomarkers in SLE: use of biomarkers in clinical trials, value of biomarkers in many aspects of SLE.

Current status of SLE biomarkers: genetic markers, diagnostic markers, markers of disease activity, disease-activity indices, end points in clinical trials.

Promising and possible biomarkers: type I interferon, sVCAM-1, CD27 high plasma cells, soluble IL-2 receptor, BLyS.

Market implications: impact of biomarkers on the SLE market.

Market outlook: outlook for development of biomarkers and their impact on pharmaceutical development.

Mentioned in This Spectrum Report-Biomarkers

• Anti-dsDNA
• BLyS
• CD19+ B cells
• CD27 high plasma cells
• CD40 ligand + lymphocytes
• Complement activation products
• Complement component C2 defi ciency
• Complement defi ciencies
• FcγRIIIa polymorphisms
• FcγRIIa polymorphisms
• IL-6
• IL-10
• IL-12 p40
• IL-13
• IL-16
• IL-18
• Immune complexes
• Interferon-alpha
• Mannose-binding lectin (MBL)
• polymorphisms
• Soluble CD27
• Soluble CD40 ligand
• Soluble IL-2 receptor (CD25)
• Soluble thrombomodulin
• Soluble TNF receptor
• Soluble VCAM-1

Table of Contents

• Executive Summary
• Strategic Considerations
• Stakeholder Implications
• Introduction
• Pathophysiology of SLE
• Biomarkers in SLE
• Biomarker Definition
• Biomarkers and Surrogate End Points
• Necessary Attributes of an SLE Biomarker
• Value of a Biomarker for SLE
• Current Status of SLE Biomarkers
• Overview
• Genetic Markers of Susceptibility, Organ Involvement, or Severity
• Diagnostic Markers
• Markers of Disease Activity
• Disease-Activity Indices and End Points in SLE Clinical Trials
• Promising and Possible SLE Biomarkers
• Type I Interferon
• sVCAM-1
• CD27 High Plasma Cells
• Soluble IL-2 Receptor (Soluble CD25)
• BLyS
• Market Implications
• Outlook

Tables

• 1. Clinical Manifestations of Systemic Lupus Erythematosus
• 2. Select Promising Genetic Biomarkers in SLE
• 3. American College of Rheumatology Classification Criteria for the Diagnosis of Systemic Lupus Erythematosus
• 4. Select Disease-Activity Indices in SLE and Their Advantages and Disadvantages

Figures

• 1. Pathogenesis of Systemic Lupus Erythematosus
• 2. Diagnosed Prevalent Cases of Systemic Lupus Erythematosus, 2005
• 3. Pipeline of Systemic Lupus Erythematosus Therapies