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Published by: Datamonitor
Published: Jun. 30, 2006 - 113 Pages
Table of Contents
- About the CNS, Arthritis and Pain pharmaceutical analysis team
- CHAPTER 1 EXECUTIVE SUMMARY
- Datamonitor insight into the lupus market
- CHAPTER 2 INTRODUCTION AND EPIDEMIOLOGY
- Classifications
- Diagnosis and severity - the "Chameleon" disease
- Cutaneous or discoid lupus
- Neuropsychiatric and CNS involvement in SLE
- Neonatal lupus erythematosus
- Drug-induced lupus erythematosus
- Raynaud's phenomenon
- Epidemiology of SLE
- Datamonitor estimates a conservative SLE patient number
- US SLE population is estimated between 200,000 and 1.5 million
- European SLE demographics benefit from Euro-Lupus study but population estimate is indistinct
- Japanese SLE population is especially difficult to estimate as data is rare
- Improved SLE survival rates are increasing prevalence
- Late morbidity risk increases as patients live longer
- Genetic influences are key in SLE epidemiology
- Race and ethnic segmentation - nature vs. nurture
- Other suggested risk factors include environmental factors
- CHAPTER 3 CURRENT TREATMENT
- Treatment algorithms vary with disease type
- Non-pharmacological treatment largely involves education and avoidence of flare triggers
- Pharmacological treatment currently revolves around steroids antimalarials and cytotoxic agents
- Prednisone and Hydroxychloroquine are the mainstay of SLE treatment
- Lupus nephritis is a key patient segment
- Non-renal lupus includes joint, skin and CNS manifestations
- Joint involvement
- Dermatological involvement
- CNS involvement and Neuropsychiatric (NP) symptoms
- CHAPTER 4 ASSESSMENT AND CLINICAL TRIAL DESIGN
- Assessment criteria vary in popularity and usefulness in certain aspects of the disease
- Systemic Lupus Erythematosus Activity Index (SLAM)
- SLICC/ACR Damage Index
- SLE Disease Activity Index (SLEDAI and SLENA-SLEDAI)
- The British Isles Lupus Assessment Group (BILAG)
- European Consensus Lupus Activity Measure (ECLAM)
- Biomarker research aims to find an accurate, easily performed test for outcome or diagnostic purposes
- Clinical trial design in SLE is a notoriously difficult task
- Key challenges in the study of drug effects in Lupus
- Specific trial designs
- Dose ranging and Phase IIa and b trials
- Disease activity
- Superior safety/similar efficacy
- Steroid sparing endpoints
- Organ specific endpoints
- Segmenting by lupus nephritis is a popular design, and invites off-label use in other SLE manifestations
- Skin specific segmentation allows approval for a larger percentage of the overall lupus population as most will suffer from skin involvement
- CHAPTER 5 INCREASING SLE MARKET OPPORTUNITIES
- Awareness is increasing but primary care physicians should be targeted
- Misdiagnosis is a problem which is being addressed by the SLICC group
- Increasing awareness and diagnosis by improved definition of SLE
- Market potential can be based on estimated sales or cost to the healthcare system
- Diagnosis value
- Cost of SLE to the healthcare system
- New treatments should be steroid sparing with a comparable side-effect profile to CellCept
- Which cells play a major role in the SLE autoimmune response?
- The risk-to-benefit profile in lupus depends on disease severity and the system affected
- Orphan drug designation is a key opportunity
- FDA requirements
- EMEA requirements and possible advantages
- Making use of patient advocacy groups and media advertising addresses challenges in clinical trial recruitment
- The UK advantage
- Recruitment
- eRecruitment and making use of the media
- Partnering with physican and patient organizations
- CHAPTER 6 PIPELINE DRUGS AND KEY TRIALS
- Immunosuppressants
- CellCept (mycophenolate mofetil)
- Arava (leflunomide)
- Riquent (abetimus)
- B-cell therapy
- Rituxan/MabThera (rituximab)
- Cost
- LymphoStat-B (belimumab)
- Epratuzumab
- Other cytokines suppression
- Actemra (tocilizumab)
- Liver enzyme irregularity with MRA is the current concern in both SLE and RA indications
- CTLA4-Ig
- Orencia (abatacept) - BMS
- RG2077 - Repligen
- Other pipeline possibilities
- Gene therapy
- Interferon suppression
- DHEA (PrestaraT)
- Autologous stem cell transplantation
- Discoid and cutaneous lupus erythematosus
- Topical immunomodulators - Protopic (tacrolimus) and Elidel (pimecrolimus)
- Raptiva (efalizumab)
- APPENDIX
- Contributing experts
- Bibliography
- Other sources
- Government sites:
- News sources:
- American College of Rheumatology links:
- Company websites:
- Patient organizations:
- Other
- About Datamonitor
- About Datamonitor Healthcare
- Datamonitor Healthcare's research and analysis methodologies
- Datamonitor Healthcare's therapy area capabilities
- Disclaimer
- List of Tables
- Table 1: Range and frequency of symptoms associated with Lupus
- Table 2: SLE population across the seven major markets, 2006
- Table 3: Key SLE epidemiology studies
- Table 4: Summary of key disease activity assessment tools
- Table 5: WHO lupus nephritis classification, 1982
- Table 6: Estimated sales for main drugs used in SLE, $ (000s), 2005
- Table 7: Variations in prevalence criteria for orphan drug status
- Table 8: Products in clinical development for lupus indications, 2006
- Table 9: Actemra (tocilizumab) development schedule in all indications, March 2006
- List of Figures
- Figure 1: SLE system and general severity range
- Figure 2: General treatments used for SLE
- Figure 3: The risk and cost verses benefit profile for different severities of lupus symptoms
- Figure 4: Geographical comparisons between the major research areas for lupus
- Figure 5: Key messages to include when advertising for patient participation
AbstractIntroduction
Systemic Lupus Erythematosus is a chronic, life-long and potentially fatal autoimmune disease characterized by multiple system distress and unpredictable flares. High unmet need makes this an attractive market but dispute over patient numbers and clinical trial difficulties are significant hurdles for new entrants to overcome.
Scope
- Assessment of patient size across the seven major markets (US, Japan, France, Germany, Italy, Spain, UK), including split by age and gender
- Qualitative interviews with key opinion leaders including treating physicians, patient advocates and research scientists
- Investigation of the current unmet needs from a range of professionals involved in SLE treatment and research
- Current treatment controversies and novel therapies in the developmental pipeline
Highlights
The main obstacle to approval of a new treatment for SLE is ambiguity in the requirements for randomized clinical trials. Recruitment is becoming a particular issue as a large number of late-Phase trials are being carried out at present. Datamonitor recommends e-recruitment, patient advocacy group collaboration and liaison with regulatory agencies.
Awareness among primary care physicians is low, but once a treatment reaches the market, companies are expected implement large marketing initiatives. This will to improve physician knowledge of the condition and available treatments, aiding the challenge of correct diagnosis of this disease, and enlarging the market.
New drugs entering the market have a number of opportunities which can be exploited by the developing company. Orphan drug status is a key advantage of the SLE market. However, improved SLE survival rates have emphasized co-morbidities, resulting in the threat of an increased risk of thrombotic events.
Reasons to Purchase
- Identify the challenges in clinical trial design including assessment tool selection and renal verses non-renal designs
- Understand the key issues for potential treatments for heterogeneous SLE patients
- Gain insight into opinion leaders' thoughts on the challenges facing the SLE market
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