Stakeholder Insight: Systemic Lupus Erythematosus Imprecise segmentation complicates treatment algorithms

Despite forming the mainstay of pharmacological treatment of anxiety disorders, response rates to serotonergic-based treatments are often less than robust. As such, physicians are increasingly looking towards novel drugs. For pharmaceutical companies, the pressure to meet this need and maintain market share is growing as the patent expiries of three major brands draws near.

Report Highlights
Atypical antipsychotics are expected to change the landscape of the future anxiety disorders market, with Seroquel XR set to benefit from first-to-market status upon approval in generalized anxiety disorder. Seroquel XR will be positioned as a second/third-line treatment for patients who have failed to respond to available antidepressants.

In view of the high co-morbidity between anxiety and depression, it remains in the interests of antidepressant manufacturers to maximize the patient potential of their products. However, with three key brands set to experience patent expiration over the forecast period (20082017), competition within the antidepressant drug classes will intensify.

The presence of neurokinin (NK) receptor antagonists and corticotrophin releasing factor (CRF) antagonists in the anxiety disorders pipeline have generated much interest among interviewed key opinion leaders. Datamonitor regards NK receptor antagonists as holding the greatest promise in the treatment of anxiety disorders.
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ABOUT DATAMONITOR HEALTHCARE 2
About the Immunology and Inflammation pharmaceutical analysis team 2
CHAPTER 1 EXECUTIVE SUMMARY 3
Scope of the analysis 3
Datamonitor insight into the systemic lupus erythematosus market 3
Contributing experts 4
Related reports 5
Upcoming related reports 5
CHAPTER 2 INTRODUCTION, SCOPE AND RESPONDENT DEMOGRAPHICS 7
Coverage of the Stakeholder Insight Survey 7
Treatment trees 7
Epidemiology 7
Diagnosis presentation and referral options 8
Patient segmentation 8
Treatment trends 8
Measuring and improving treatment outcomes 8
Assumptions and caveats 9
Terminology 9
Physician demographics 9
Rheumatologists in Japan show almost 20 years experience in specialist practice 9
Future trends 12
CHAPTER 3 COUNTRY TREATMENT TREES 13
Introduction to treatment trees 13
Overview 14
US 15
Japan 16
France 17
Germany 18
Italy 19
Spain 20
UK 21
CHAPTER 4 EPIDEMIOLOGY 22
Etiology and symptoms 23
Lupus affects less than 1% of the population in the seven major markets 24
US rheumatologists see at least twice as many systemic lupus erythematosus patients compared to the other major markets 26
US rheumatologists see more new systemic lupus erythematosus sufferers than other major markets 28
Key studies investigating systemic lupus erythematosus 31
US 36
Datamonitor estimates almost 250,000 systemic lupus erythematosus patients in the US 36
Estimated systemic lupus erythematosus prevalent population in the US can be split by race 40
Japan 41
Estimating systemic lupus erythematosus population in Japan is a challenge due to lack of recent prevalence data 41
EU 43
France 43
Systemic lupus erythematosus prevalence data from Spain can be applied to France 43
Germany 44
German systemic lupus erythematosus prevalence calculated by applying UK estimates 44
Italy 45
Italian systemic lupus erythematosus prevalence based on robust study from the Ferrara region 45
Spain 46
Systemic lupus erythematosus population in Spain is low in comparison to northern European countries 46
UK 47
Systemic lupus erythematosus population split by sex in the UK 47
Rest of the world 49
Systemic lupus erythematosus prevalence in Northern European countries is high with immigration considered an important contributor 52
Large systemic lupus erythematosus patient potential in Asian region, but more epidemiology studies required 52
CHAPTER 5 DIAGNOSIS, PRESENTATION AND REFERRAL OPTIONS 54
Presentation and diagnosis 55
Rheumatologists are the main systemic lupus erythematosus care-givers 55
Time to systemic lupus erythematosus diagnosis shortest in Japan, longest in the UK 58
Total time to diagnosis more than a year and a half in the UK and Germany 58
Average time from onset of symptoms to presentation over 10 months in the UK, but less than 5 months in Japan 60
Longer time from initial presentation to diagnosis seen for 'gatekeeper' primary care systems 61
Largest proportion of systemic lupus erythematosus sufferers present to a primary care physician 63
Half of systemic lupus erythematosus sufferers diagnosed by a rheumatologist 64
Treatment rates 68
Patient and physician education key to earlier diagnosis and treatment 68
CHAPTER 6 PATIENT SEGMENTATION 70
Patient segmentation for systemic lupus erythematosus is a significant challenge 71
Kidney and CNS specific involvement increases with systemic lupus erythematosus severity 73
US and Japan show high lupus nephritis patient volume 78
Total 79
US 80
Japan 81
France 82
Germany 83
Italy 84
Spain 85
UK 86
CHAPTER 7 TREATMENT TRENDS 87
Overview of treatment guidelines for systemic lupus erythematosus 88
ACR Guidelines for the referral and management of systemic lupus erythematosus in adults 89
EULAR recommendations for the management of systemic lupus erythematosus 91
Pharmacological and non-pharmacological therapy use 93
Pharmacological treatment essential for major organ involvement 93
Lupus subsets by organ-specific involvement 97
Nearly all systemic lupus erythematosus sufferers with major organ involvement are drug-treated 97
Multiple organ involvement 98
Multiple organ disease treated predominantly with corticosteroids 98
Cutaneous lupus 100
Antimalarials used to treat cutaneous lupus 100
Blood involvement 102
Over half of sufferers receive systemic corticosteroids 102
Neuropsychiatric 104
Treatment mainly with systemic corticosteroids 104
Lupus nephritis 107
Over 40% of patients treated with cytotoxic agents 107
Joint involvement 109
Joint manifestation commonly treated with antimalarials 109
Drug classes used in systemic lupus erythematosus treatment 110
Corticosteroids 110
Corticosteroids are the foundation of systemic lupus erythematosus therapy and are used in over half of sufferers 111
Topical corticosteroids appropriate for cutaneous lupus treatment 113
Immunosuppressants 113
Highest immunosuppressant use seen for major organ involvement 113
CellCept development halted, but off-label use expected to continue 113
Antimalarials 114
Antimalarials used to treat systemic lupus erythematosus across the broad spectrum of disease involvement 114
Cytotoxic agents 116
Cytotoxics target neuropsychiatric and renal involvement 116
NSAIDs and COX-2s 116
NSAIDS treat milder inflammation and pain 116
Biologics 117
Uptake of biologics highest for patients with lupus nephritis 117
Rituxan/MabThera (rituximab) 118
Opinion leaders seek to treat systemic lupus erythematosus sufferers with Rituxan/MabThera 118
Rituxan/MabThera poorly perceived in Japan but popular in the US 119
CHAPTER 8 MEASURING AND IMPROVING TREATMENT OUTCOMES 124
Measuring disease activity and damage 125
SLICC/ACR Damage Index 125
Four major indices used to measure systemic lupus erythematosus disease activity 126
Systemic Lupus Erythematosus Disease Activity Index (SLEDAI and SELENA-SLEDAI) 127
The British Isles Lupus Assessment Group (BILAG) 128
European Consensus Lupus Activity Measure (ECLAM) 129
Systemic Lupus Erythematosus Activity Index (SLAM) 130
Over half of rheumatologists use SLEDAI to measure activity 130
Variation in disease activity index use is a potential obstacle to clinical trial success 133
One-third of rheumatologists use more than one systemic lupus erythematosus activity index 133
A small proportion of rheumatologists in the US and France prefer not to use a recognized disease activity index 133
Extent of organ damage is critical to assessing global systemic lupus erythematosus disease activity 134
Rheumatologists moderately satisfied with treatment efficacy measurement 136
Challenges and unmet needs in systemic lupus erythematosus 138
Development of effective, steroid-sparing therapies seen as highest priority 138
Moderate satisfaction shown with current systemic lupus erythematosus treatments 141
BIBLIOGRAPHY 143
Journal papers 143
Books 150
Websites 150
Datamonitor reports 151
APPENDIX A 152
Physician research methodology 152
Physician sample breakdown 152
Contributing experts 153
APPENDIX B 154
The survey questionnaire 154
Screener 154
1 Epidemiology 155
2 Diagnosis and patient segmentation 155
3 Treatment 160
4 Treatment Outcomes 165
5 Prescribing Factors for Rheumatological Disease 167
About Datamonitor 170
About Datamonitor Healthcare 170
About the Immunology and Inflammation (I&I) analysis team 171
Disclaimer 172
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Table 1: Systemic lupus erythematosus population, split by sex across the seven major markets, 2008 24
Table 2: Mean number of systemic lupus erythematosus patients seen per year across the seven major markets (%), 2008 27
Table 3: Mean number of systemic lupus erythematosus patients seen per year across the seven major markets, 2008 28
Table 4: Mean number of new systemic lupus erythematosus patients seen per year, across the seven major markets (%), 2008 30
Table 5: Key systemic lupus erythematosus prevalence studies across the seven major markets, 1974-2008 32
Table 6: Varying systemic lupus erythematosus prevalence estimates applied to the US population, including a split by gender, 2008 39
Table 7: Systemic lupus erythematosus prevalence estimates by racial group applied to the US population, 2008 41
Table 8: Varying systemic lupus erythematosus prevalence estimates applied to the Japanese population, including data from a Japanese population in Hawaii, 2008 42
Table 9: Varying SLE prevalence estimates applied to the French population, including a split by gender, 2008 43
Table 10: Gender-specific prevalence data for systemic lupus erythematosus from the UK applied to German population data, 2008 44
Table 11: Estimate of systemic lupus erythematosus population in Italy, 2008 45
Table 12: Varying systemic lupus erythematosus prevalence estimates applied to the Spain population, split by gender, 2008 46
Table 13: Varying systemic lupus erythematosus (SLE) prevalence estimates applied to the UK population, including split by gender and race, 2008 48
Table 14: Key systemic lupus erythematosus prevalence studies in the rest of the world, 1985-2008 50
Table 15: Total length of time from onset of symptoms to systemic lupus erythematosus diagnosis across the seven major markets, 2008 60
Table 16: Systemic lupus erythematosus population in the seven major markets, split by primary manifestation and disease severity (%), 2008 74
Table 17: Percentage of systemic lupus erythematosus (SLE) patients with different involvements in Okinawa, Japan, 1972-1991 76
Table 18: Percentage of systemic lupus erythematosus patients receiving pharmacological and non-pharmacological therapy, by disease severity across the seven major markets, 2008 95
Table 19: Drug class usage in systemic lupus erythematosus by site of involvement, across the seven major markets, 2008 96
Table 20: Number of physicians and the estimated percentage of their systemic lupus erythematosus patients with multiple organ involvement receiving each drug class, 2008 99
Table 21: Number of physicians and the estimated percentage of their systemic lupus erythematosus patients with cutaneous lupus receiving each drug class, 2008 100
Table 22: Number of physicians and the estimated percentage of their systemic lupus erythematosus patients with blood involvement receiving each drug class, 2008 103
Table 23: Number of physicians and the estimated percentage of their systemic lupus erythematosus patients with neuropsychiatric involvement receiving each drug class, 2008 104
Table 24: Number of physicians and the estimated percentage of their systemic lupus erythematosus patients with lupus nephritis receiving each drug class, 2008 107
Table 25: Number of physicians and the estimated percentage of their systemic lupus erythematosus patients with joint involvement receiving each drug class, 2008 109
Table 26: Systemic and topical corticosteroid usage in systemic lupus erythematosus patients by site of involvement across the seven major markets, 2008 111
Table 27: Traditional NSAID and COX-2 usage in systemic lupus erythematosus patients by site of involvement across the seven major markets, 2008 117
Table 28: Mean points allocated to each attribute (out of 100) for relative importance when prescribing Rituxan/MabThera, 2008 122
Table 29: Comparison of major systemic lupus erythematosus disease activity indices, 2008 127
Table 30: Percentage of physicians reporting use of systemic lupus erythematosus disease activity and damage indices across the seven major markets, 2008 132
Table 31: Mean rating allocated by rheumatologists to the importance of each element of disease activity in assessing systemic lupus erythematosus in clinical practice across the seven major markets, 2008 135
Table 32: Mean rating allocated by rheumatologists to each systemic lupus erythematosus disease activity measure for effectiveness of measuring treatment efficacy, 2008 137
Table 33: Physician sample breakdown 152
Figure 1: Mean number of years spent in specialist practice by rheumatologists across the seven major markets, 2008 10
Figure 2: Number of hours spent in clinical practice per day by rheumatologists, 2008 11
Figure 3: Seven major market systemic lupus erythematosus patient population split by physician-estimated diagnoses, primary manifestation, drug-treated population, and drug-class usage, 2008 14
Figure 4: US systemic lupus erythematosus patient population, split by physician-estimated diagnoses, primary manifestation, drug-treated population, and drug-class usage, 2008 15
Figure 5: Japan systemic lupus erythematosus patient population, split by physician-estimated diagnoses, primary manifestation, drug-treated population, and drug-class usage, 2008 16
Figure 6: France systemic lupus erythematosus patient population, split by physician-estimated diagnoses, primary manifestation, drug-treated population, and drug-class usage, 2008 17
Figure 7: Germany systemic lupus erythematosus patient population, split by physician-estimated diagnoses, primary manifestation, drug-treated population, and drug-class usage, 2008 18
Figure 8: Italy systemic lupus erythematosus patient population, split by physician-estimated diagnoses, primary manifestation, drug-treated population, and drug-class usage, 2008 19
Figure 9: Spain systemic lupus erythematosus patient population, split by physician-estimated diagnoses, primary manifestation, drug-treated population, and drug-class usage, 2008 20
Figure 10: UK systemic lupus erythematosus patient population, split by physician-estimated diagnoses, primary manifestation, drug-treated population, and drug-class usage, 2008 21
Figure 11: Mean number and range of systemic lupus erythematosus patients seen per year across the seven major markets, 2008 26
Figure 12: Mean number of new systemic lupus erythematosus patients seen per year across the seven major markets, 2008 29
Figure 13: Presentation, diagnosis, treatment initiation, and long-term management of systemic lupus erythematosus by physician type across the seven major markets, 2008 56
Figure 14: Total length of time from onset of symptoms to systemic lupus erythematosus diagnosis across the seven major markets, 2008 59
Figure 15: Mean percentage of systemic lupus erythematosus patients presenting to each physician type across the seven major markets, 2008 63
Figure 16: Mean percentage of systemic lupus erythematosus patients diagnosed by each physician type, across the seven major markets, 2008 65
Figure 17: Mean percentage of systemic lupus erythematosus patients receiving treatment initiation by physician type, across the seven major markets, 2008 66
Figure 18: Mean percentage of systemic lupus erythematosus patients receiving long-term management by physician type across the seven major markets, 2008 67
Figure 19: Total systemic lupus erythematosus population in the seven major markets, split by primary manifestation and disease severity, 2008 74
Figure 20: Mean number of disease flares in systemic lupus erythematosus patients seen per year, by disease severity, 2008 77
Figure 21: Total systemic lupus erythematosus patient population, split by physician-estimated diagnoses, disease severity, and drug-treated population - also including primary manifestation by disease severity, 2008 79
Figure 22: US systemic lupus erythematosus patient population, split by physician-estimated diagnoses, disease severity, and drug-treated population - also including primary manifestation by disease severity, 2008 80
Figure 23: Japan systemic lupus erythematosus patient population, split by physician-estimated diagnoses, disease severity, and drug-treated population - also including primary manifestation by disease severity, 2008 81
Figure 24: France systemic lupus erythematosus patient population, split by physician-estimated diagnoses, disease severity, and drug-treated population - also including primary manifestation by disease severity, 2008 82
Figure 25: Germany systemic lupus erythematosus patient population, split by physician-estimated diagnoses, disease severity, and drug-treated population - also including primary manifestation by disease severity, 2008 83
Figure 26: Italy systemic lupus erythematosus patient population, split by physician-estimated diagnoses, disease severity, and drug-treated population - also including primary manifestation by disease severity, 2008 84
Figure 27: Spain systemic lupus erythematosus patient population, split by physician-estimated diagnoses, disease severity, and drug-treated population - also including primary manifestation by disease severity, 2008 85
Figure 28: UK systemic lupus erythematosus patient population, split by physician-estimated diagnoses, disease severity, and drug-treated population - also including primary manifestation by disease severity, 2008 86
Figure 29: Systemic lupus erythematosus treatment algorithm based on ACR guidelines 90
Figure 30: Systemic lupus erythematosus (SLE) treatment algorithm based on EULAR recommendations 92
Figure 31: Percentage of systemic lupus erythematosus patients receiving pharmacological and non-pharmacological therapy, by disease severity across the seven major markets, 2008 94
Figure 32: Drug class usage in systemic lupus erythematosus by site of involvement across the seven major markets, 2008 98
Figure 33: Distribution of 100 points by attribute, according to importance to prescribing decision for rheumatologists, 2008 120
Figure 34: Mean rating by attribute given by rheumatologists for Rituxan/MabThera across the seven major markets, 2008 121
Figure 35: Percentage of physicians reporting use of systemic lupus erythematosus disease activity and damage indices across the seven major markets, 2008 131
Figure 36: Mean rating allocated by rheumatologists to the importance of each element of disease activity in assessing systemic lupus erythematosus in clinical practice across the seven major markets, 2008 134
Figure 37: Mean rating allocated by rheumatologists representing how well each index measures treatment efficacy, 2008 136
Figure 38: Priority rating allocated by rheumatologists to challenges in systemic lupus erythematosus management, 2008 139
Figure 39: Rheumatologists' satisfaction with currently available systemic lupus erythematosus treatments across the seven major markets, 2008 141
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