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
