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)
- 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
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