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Stakeholder Insight: Systemic Lupus Erythematosus Imprecise segmentation complicates treatment algorithms

Published by: Datamonitor

Published: Nov. 18, 2008 - 179 Pages


Table of Contents



CHAPTER 1 EXECUTIVE SUMMARY

Scope of the analysis

Datamonitor insight into the systemic lupus erythematosus market

Contributing experts

Related reports

Upcoming related reports

CHAPTER 2 INTRODUCTION, SCOPE AND RESPONDENT DEMOGRAPHICS

Coverage of the Stakeholder Insight Survey

Treatment trees

Epidemiology

Diagnosis presentation and referral options

Patient segmentation

Treatment trends

Measuring and improving treatment outcomes

Assumptions and caveats

Terminology

Physician demographics

Rheumatologists in Japan show almost 20 years experience in specialist practice

Future trends

CHAPTER 3 COUNTRY TREATMENT TREES

Introduction to treatment trees

Overview

US

Japan

France

Germany

Italy

Spain

UK

CHAPTER 4 EPIDEMIOLOGY

Etiology and symptoms

Lupus affects less than 1% of the population in the seven major markets

US rheumatologists see at least twice as many systemic lupus erythematosus patients compared to the other major markets

US rheumatologists see more new systemic lupus erythematosus sufferers than other major markets

Key studies investigating systemic lupus erythematosus

US

Datamonitor estimates almost 250,000 systemic lupus erythematosus patients in the US

Estimated systemic lupus erythematosus prevalent population in the US can be split by race

Japan

Estimating systemic lupus erythematosus population in Japan is a challenge due to lack of recent prevalence data

EU

France

Systemic lupus erythematosus prevalence data from Spain can be applied to France

Germany

German systemic lupus erythematosus prevalence calculated by applying UK estimates

Italy

Italian systemic lupus erythematosus prevalence based on robust study from the Ferrara region

Spain

Systemic lupus erythematosus population in Spain is low in comparison to northern European countries

UK

Systemic lupus erythematosus population split by sex in the UK

Rest of the world

Systemic lupus erythematosus prevalence in Northern European countries is high with immigration considered an important contributor

Large systemic lupus erythematosus patient potential in Asian region, but more epidemiology studies required

CHAPTER 5 DIAGNOSIS, PRESENTATION AND REFERRAL OPTIONS

Presentation and diagnosis

Rheumatologists are the main systemic lupus erythematosus care-givers

Time to systemic lupus erythematosus diagnosis shortest in Japan, longest in the UK

Total time to diagnosis more than a year and a half in the UK and Germany

Average time from onset of symptoms to presentation over 10 months in the UK, but less than 5 months in Japan

Longer time from initial presentation to diagnosis seen for ‘gatekeeper’ primary care systems

Largest proportion of systemic lupus erythematosus sufferers present to a primary care physician

Half of systemic lupus erythematosus sufferers diagnosed by a rheumatologist

Treatment rates

Patient and physician education key to earlier diagnosis and treatment

CHAPTER 6 PATIENT SEGMENTATION

Patient segmentation for systemic lupus erythematosus is a significant challenge

Kidney and CNS specific involvement increases with systemic lupus erythematosus severity

US and Japan show high lupus nephritis patient volume

Total

US

Japan

France

Germany

Italy

Spain

UK

CHAPTER 7 TREATMENT TRENDS

Overview of treatment guidelines for systemic lupus erythematosus

ACR Guidelines for the referral and management of systemic lupus erythematosus in adults

EULAR recommendations for the management of systemic lupus erythematosus

Pharmacological and non-pharmacological therapy use

Pharmacological treatment essential for major organ involvement

Lupus subsets by organ-specific involvement

Nearly all systemic lupus erythematosus sufferers with major organ involvement are drug-treated

Multiple organ involvement

Multiple organ disease treated predominantly with corticosteroids

Cutaneous lupus

Antimalarials used to treat cutaneous lupus

Blood involvement

Over half of sufferers receive systemic corticosteroids

Neuropsychiatric

Treatment mainly with systemic corticosteroids

Lupus nephritis

Over 40% of patients treated with cytotoxic agents

Joint involvement

Joint manifestation commonly treated with antimalarials

Drug classes used in systemic lupus erythematosus treatment

Corticosteroids

Corticosteroids are the foundation of systemic lupus erythematosus therapy and are used in over half of sufferers

Topical corticosteroids appropriate for cutaneous lupus treatment

Immunosuppressants

Highest immunosuppressant use seen for major organ involvement

CellCept development halted, but off-label use expected to continue

Antimalarials

Antimalarials used to treat systemic lupus erythematosus across the broad spectrum of disease involvement

Cytotoxic agents

Cytotoxics target neuropsychiatric and renal involvement

NSAIDs and COX-2s

NSAIDS treat milder inflammation and pain

Biologics

Uptake of biologics highest for patients with lupus nephritis

Rituxan/MabThera (rituximab)

Opinion leaders seek to treat systemic lupus erythematosus sufferers with Rituxan/MabThera

Rituxan/MabThera poorly perceived in Japan but popular in the US

CHAPTER 8 MEASURING AND IMPROVING TREATMENT OUTCOMES

Measuring disease activity and damage

SLICC/ACR Damage Index

Four major indices used to measure systemic lupus erythematosus disease activity

Systemic Lupus Erythematosus Disease Activity Index (SLEDAI and SELENA-SLEDAI)

The British Isles Lupus Assessment Group (BILAG)

European Consensus Lupus Activity Measure (ECLAM)

Systemic Lupus Erythematosus Activity Index (SLAM)

Over half of rheumatologists use SLEDAI to measure activity

Variation in disease activity index use is a potential obstacle to clinical trial success

One-third of rheumatologists use more than one systemic lupus erythematosus activity index

A small proportion of rheumatologists in the US and France prefer not to use a recognized disease activity index

Extent of organ damage is critical to assessing global systemic lupus erythematosus disease activity

Rheumatologists moderately satisfied with treatment efficacy measurement

Challenges and unmet needs in systemic lupus erythematosus

Development of effective, steroid-sparing therapies seen as highest priority

Moderate satisfaction shown with current systemic lupus erythematosus treatments

BIBLIOGRAPHY

Journal papers

Books

Websites

Datamonitor reports

APPENDIX A

Physician research methodology

Physician sample breakdown

Contributing experts

APPENDIX B

The survey questionnaire

Screener

1 Epidemiology

2 Diagnosis and patient segmentation

3 Treatment

4 Treatment Outcomes

5 Prescribing Factors for Rheumatological Disease

About Datamonitor

About Datamonitor Healthcare

About the Immunology and Inflammation (I&I) analysis team

Disclaimer

Abstract

Introduction

Lupus is a chronic, autoimmune disorder, characterized by unpredictable flares and remissions. Affected areas can include the joints, skin, kidneys, heart, lungs, blood vessels and the brain. There are currently only three medications approved for the treatment of lupus; hydroxychloroquine, aspirin, and prednisone, highlighting the significant unmet need.

Scope
  • Analysis of the lupus market based on a survey of 180 rheumatologists supported by key opinion leader interviews
  • Detailed overview of epidemiology in lupus benchmarked against physician perception
  • Patient segmentation by both disease severity and organ involvement (multiple organ disease, skin, joints, blood, CNS, and kidney)
  • Assessment of treatment trends and outcome measures
Highlights

Rheumatologists provide the long-term management for two-thirds of lupus patients. 40% of patients present to a primary care physician, and most are referred to a rheumatologist for diagnosis. Long-term care is also linked to the major organ involved, for example 10% of patients receive long term management from a nephrologist.

The development of effective, steroid-sparing therapies is the highest priority for pharmaceutical companies to address. Biologics will play a prominent therapeutic role over the next few years. Current biologic use by involvement varies between 2% and 10%, whilst steroid uptake varies between 37% and 69%.

Four major indices are predominantly used, creating a hindrance to the application of clinical trial data, and one third of rheumatologists actually use more than one index in clinical practice. The extent of organ damage was considered the most important issue of disease activity assessment, followed by antibody and inflammatory marker levels.

Reasons to Purchase
  • Gain competitive advantage with one of the most extensive primary research reports available in lupus, with data from 180 prescribing rheumatologists
  • Identify with prescribers more effectively, through an understanding of referral patterns based on data-rich treatment numbers
  • Validate new product forecasting based on diagnosis rates and treatment by patient segmentation and drug therapy class


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