Systemic Lupus Erythematosus - On the Verge of a Breakthough
Scope
Report Highlights
Reasons to Purchase
Table of Contents
- About the CNS, Arthritis and Pain pharmaceutical analysis team - page 2
- CHAPTER 1 EXECUTIVE SUMMARY - page 3
- Datamonitor insight into the lupus market - page 3
- CHAPTER 2 INTRODUCTION AND EPIDEMIOLOGY - page 9
- Classifications - page 9
- Diagnosis and severity - the "Chameleon" disease - page 9
- Cutaneous or discoid lupus - page 13
- Neuropsychiatric and CNS involvement in SLE - page 14
- Neonatal lupus erythematosus - page 15
- Drug-induced lupus erythematosus - page 15
- Raynaud's phenomenon - page 15
- Diagnosis and severity - the "Chameleon" disease - page 9
- Epidemiology of SLE - page 16
- Datamonitor estimates a conservative SLE patient number - page 16
- US SLE population is estimated between 200,000 and 1.5 million - page 20
- European SLE demographics benefit from Euro-Lupus study but population estimate is indistinct - page 21
- Japanese SLE population is especially difficult to estimate as data is rare - page 24
- Improved SLE survival rates are increasing prevalence - page 25
- Late morbidity risk increases as patients live longer - page 25
- Genetic influences are key in SLE epidemiology - page 27
- Race and ethnic segmentation - nature vs. nurture - page 27
- Other suggested risk factors include environmental factors - page 29
- Datamonitor estimates a conservative SLE patient number - page 16
- Classifications - page 9
- CHAPTER 3 CURRENT TREATMENT - page 31
- Treatment algorithms vary with disease type - page 31
- Non-pharmacological treatment largely involves education and avoidence of flare triggers - page 31
- Pharmacological treatment currently revolves around steroids antimalarials and cytotoxic agents - page 32
- Prednisone and Hydroxychloroquine are the mainstay of SLE treatment - page 32
- Lupus nephritis is a key patient segment - page 35
- Non-renal lupus includes joint, skin and CNS manifestations - page 36
- Joint involvement - page 36
- Dermatological involvement - page 37
- CNS involvement and Neuropsychiatric (NP) symptoms - page 37
- Treatment algorithms vary with disease type - page 31
- CHAPTER 4 ASSESSMENT AND CLINICAL TRIAL DESIGN - page 40
- Assessment criteria vary in popularity and usefulness in certain aspects of the disease - page 40
- Systemic Lupus Erythematosus Activity Index (SLAM) - page 43
- SLICC/ACR Damage Index - page 43
- SLE Disease Activity Index (SLEDAI and SLENA-SLEDAI) - page 44
- The British Isles Lupus Assessment Group (BILAG) - page 45
- European Consensus Lupus Activity Measure (ECLAM) - page 46
- Biomarker research aims to find an accurate, easily performed test for outcome or diagnostic purposes - page 47
- Clinical trial design in SLE is a notoriously difficult task - page 48
- Key challenges in the study of drug effects in Lupus - page 49
- Specific trial designs - page 50
- Dose ranging and Phase IIa and b trials - page 51
- Disease activity - page 51
- Superior safety/similar efficacy - page 52
- Steroid sparing endpoints - page 52
- Organ specific endpoints - page 54
- Segmenting by lupus nephritis is a popular design, and invites off-label use in other SLE manifestations - page 54
- Skin specific segmentation allows approval for a larger percentage of the overall lupus population as most will suffer from skin involvement - page 56
- Assessment criteria vary in popularity and usefulness in certain aspects of the disease - page 40
- CHAPTER 5 INCREASING SLE MARKET OPPORTUNITIES - page 57
- Awareness is increasing but primary care physicians should be targeted - page 57
- Misdiagnosis is a problem which is being addressed by the SLICC group - page 59
- Increasing awareness and diagnosis by improved definition of SLE - page 59
- Market potential can be based on estimated sales or cost to the healthcare system - page 61
- Diagnosis value - page 62
- Cost of SLE to the healthcare system - page 64
- New treatments should be steroid sparing with a comparable side-effect profile to CellCept - page 65
- Which cells play a major role in the SLE autoimmune response? - page 66
- The risk-to-benefit profile in lupus depends on disease severity and the system affected - page 66
- Orphan drug designation is a key opportunity - page 67
- FDA requirements - page 68
- EMEA requirements and possible advantages - page 69
- Making use of patient advocacy groups and media advertising addresses challenges in clinical trial recruitment - page 70
- The UK advantage - page 70
- Recruitment - page 72
- eRecruitment and making use of the media - page 73
- Partnering with physican and patient organizations - page 76
- Awareness is increasing but primary care physicians should be targeted - page 57
- CHAPTER 6 PIPELINE DRUGS AND KEY TRIALS - page 78
- Immunosuppressants - page 80
- CellCept (mycophenolate mofetil) - page 80
- Arava (leflunomide) - page 82
- Riquent (abetimus) - page 83
- B-cell therapy - page 84
- Rituxan/MabThera (rituximab) - page 85
- Cost - page 87
- LymphoStat-B (belimumab) - page 88
- Epratuzumab - page 89
- Rituxan/MabThera (rituximab) - page 85
- Other cytokines suppression - page 90
- Actemra (tocilizumab) - page 90
- Liver enzyme irregularity with MRA is the current concern in both SLE and RA indications - page 92
- CTLA4-Ig - page 92
- Orencia (abatacept) - BMS - page 93
- RG2077 - Repligen - page 94
- Actemra (tocilizumab) - page 90
- Other pipeline possibilities - page 95
- Gene therapy - page 95
- Interferon suppression - page 96
- DHEA (PrestaraT) - page 97
- Autologous stem cell transplantation - page 97
- Discoid and cutaneous lupus erythematosus - page 98
- Topical immunomodulators - Protopic (tacrolimus) and Elidel (pimecrolimus) - page 99
- Raptiva (efalizumab) - page 99
- Immunosuppressants - page 80
- APPENDIX - page 100
- Contributing experts - page 100
- Bibliography - page 102
- Other sources - page 108
- Government sites: - page 108
- News sources: - page 108
- American College of Rheumatology links: - page 109
- Company websites: - page 109
- Patient organizations: - page 109
- Other - page 109
- Other sources - page 108
- About Datamonitor - page 110
- About Datamonitor Healthcare - page 110
- Datamonitor Healthcare's research and analysis methodologies - page 111
- Datamonitor Healthcare's therapy area capabilities - page 111
- Disclaimer - page 113
- List of Tables
- Table 1: Range and frequency of symptoms associated with Lupus - page 10
- Table 2: SLE population across the seven major markets, 2006 - page 17
- Table 3: Key SLE epidemiology studies - page 19
- Table 4: Summary of key disease activity assessment tools - page 41
- Table 5: WHO lupus nephritis classification, 1982 - page 54
- Table 6: Estimated sales for main drugs used in SLE, $ (000s), 2005 - page 63
- Table 7: Variations in prevalence criteria for orphan drug status - page 69
- Table 8: Products in clinical development for lupus indications, 2006 - page 78
- Table 9: Actemra (tocilizumab) development schedule in all indications, March 2006 - page 91
- List of Figures
- Figure 1: SLE system and general severity range - page 12
- Figure 2: General treatments used for SLE - page 34
- Figure 3: The risk and cost verses benefit profile for different severities of lupus symptoms - page 67
- Figure 4: Geographical comparisons between the major research areas for lupus - page 71
- Figure 5: Key messages to include when advertising for patient participation - page 75
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