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 spondyloarthropathies market 3
Contributing experts 4
Related reports 5
Upcoming related reports 5
CHAPTER 2 INTRODUCTION AND SCOPE 7
Coverage of the Stakeholder Insight survey 7
Treatment trees 8
Epidemiology 8
Diagnosis presentation and referral options 8
Treatment trends 9
Improving treatment outcomes 10
Assumptions and caveats 10
Physician demographics 10
Rheumatologists in Japan show almost 20 years experience in specialist practice 10
Dermatologists surveyed treat an average of 13 psoriatic arthritis patients per month 11
CHAPTER 3 COUNTRY TREATMENT TREES 12
Introduction to treatment trees 12
Psoriatic arthritis 13
US 13
Japan 14
France 15
Germany 16
Italy 17
Spain 18
UK 19
Ankylosing spondylitis 20
US 20
Japan 21
France 22
Germany 23
Italy 24
Spain 25
UK 26
CHAPTER 4 EPIDEMIOLOGY AND PATIENT SEGMENTATION 27
Genetic basis of spondyloarthropathies 28
Recent research indicates that three genes play a role in ankylosing spondylitis 28
HLA-B27 importance to psoriatic arthritis yet to be defined 29
Psoriatic arthritis prevalence 30
US 31
One large-scale, robust, population-based study of the epidemiology of psoriatic arthritis 31
Japan 32
While psoriatic arthritis is rare in Japan, its epidemiology is well articulated 32
France 33
Prevalence of psoriatic arthritis in France has been debated in recent years 33
Germany 33
Psoriatic arthritis prevalence difficult to pinpoint in the absence of robust analysis 33
Italy 34
High prevalence of psoriatic arthritis indicated by MAPPING study 34
Spain 34
Psoriatic arthritis prevalence can be estimated from data covering psoriasis and psoriatic arthritis 34
UK 35
Estimating the prevalence of psoriatic arthritis in the UK is complicated owing to limited published data 35
Patient segmentation for psoriatic arthritis 35
Subgroups within psoriatic arthritis complicate segmentation 38
Psoriatic arthritis most often affects middle-aged Caucasians with pre-existing psoriasis 39
Ankylosing spondylitis prevalence 40
Etiology and symptoms 40
Datamonitor estimates over 1 million ankylosing spondylitis patients in the seven major markets in 2008 41
US 44
Datamonitor estimates there are nearly 400,000 ankylosing spondylitis patients in the US 44
Japan 45
Ankylosing spondylitis prevalence much lower in Japan than in Caucasian populations 45
France 46
Ankylosing spondylitis prevalence in France is comparable to other predominantly Caucasian populations 46
Germany 47
German ankylosing spondylitis prevalence estimated by applying data from Finland 47
Spain 48
Spanish ankylosing spondylitis prevalence calculated by applying Italian estimates 48
Italy 48
Ankylosing spondylitis prevalence in Italy is more than twice that in Northern European countries 48
UK 49
Robust ankylosing spondylitis prevalence data from the UK is sparse 49
Patient segmentation for ankylosing spondylitis 50
Nearly all ankylosing spondylitis patients experience joint or eye involvement 51
CHAPTER 5 DIAGNOSIS, PRESENTATION AND REFERRAL OPTIONS 54
Psoriatic arthritis 55
Presentation and diagnosis 55
Psoriatic arthritis differs significantly from rheumatoid arthritis 55
Psoriatic arthritis typically affects the skin before it affects the joints 56
Diagnosed versus undiagnosed patient populations 58
Time to diagnosis 60
Total time to diagnosis can exceed 2 years in the US, UK and Germany 60
Mean time from onset of symptoms to presentation longest in the US and UK, and shortest in Spain and Japan 63
Longer time from initial presentation to diagnosis seen in care systems requiring referral to specialist 64
Care pathways from presentation to therapy maintenance 65
Rheumatologists, followed by dermatologists, are the main care-givers in psoriatic arthritis 65
Psoriatic arthritis patients typically present in primary care or dermatology 68
Rheumatologists and dermatologists typically diagnose psoriatic arthritis 71
Rheumatologists and dermatologists tend to initiate treatment after making a diagnosis 74
Rheumatologists have primary responsibility for long-term management of psoriatic arthritis 77
Ankylosing spondylitis 80
Presentation and diagnosis 80
Diagnosed versus undiagnosed patient populations 80
Nearly half of ankylosing spondylitis patients in the US remain undiagnosed 80
Patient and physician education can contribute to earlier diagnosis and treatment 82
Time to diagnosis 83
Late radiographic sacroiliitis is a major contributor to delayed diagnosis 83
Care pathways from presentation to therapy maintenance 89
Orthopedists/orthopedic surgeons also play an important role in long-term care of ankylosing spondylitis patients 89
Presentation is shared equally between primary care physicians and specialists 91
Orthopedists/orthopedic surgeons in Japan play an important role in diagnosis 93
Rheumatologists are best placed to initiate treatment given the underlying inflammation that characterizes ankylosing spondylitis 95
Over three-quarters of ankylosing spondylitis sufferers receive long-term management by a rheumatologist 96
CHAPTER 6 TREATMENT OPTIONS AND TRENDS 99
Overview of treatment guidelines for psoriatic arthritis and ankylosing spondylitis 100
Latest consensus guidelines for psoriatic arthritis released in October 2008 100
ASAS and EULAR have collaborated to produce international guidelines for the management of ankylosing spondylitis 102
Pharmacological and non-pharmacological therapy use 104
Pharmacological treatment is favored in the management of psoriatic arthritis 104
Pharmacological treatment is essential to control pain and inflammation experienced by ankylosing spondylitis patients 111
Analgesics 114
Analgesic use in psoriatic arthritis is highest in the UK and France 114
One-third of severe ankylosing spondylitis patients receive analgesics 115
NSAIDs and COX-2 inhibitors 116
NSAIDS form the foundation of pain management by rheumatologists in psoriatic arthritis 116
NSAIDs play an important role in treating pain and inflammation across all ankylosing spondylitis patient types 119
Corticosteroids 121
Systemic corticosteroids are used with caution in psoriatic arthritis 121
Corticosteroids treat sacroiliac joint pain in ankylosing spondylitis 123
Systemic immunosuppressants 124
Despite risks, immunosuppressants are popular in moderate and severe psoriatic arthritis 124
Systemic immunosuppressant use in ankylosing spondylitis increases with disease severity 126
Traditional DMARDs 127
In psoriatic arthritis, traditional DMARDs tend to be more effective for arthritis symptoms than psoriasis 127
Traditional DMARDs remain prominent in ankylosing spondylitis treatment 129
Anti-TNFs 130
Rheumatologists use anti-TNFs more aggressively in psoriatic arthritis than dermatologists 130
Anti-TNFs are important in controlling severe disease and reducing the dependence of ankylosing spondylitis treatment on NSAIDs 133
Additional therapies for psoriatic arthritis 136
Topical NSAIDs are used infrequently in psoriatic arthritis 136
Topical vitamin derivatives 137
Topical corticosteroids 138
Topical immunomodulators 140
Cytotoxic agents 141
Patients have ample support; physicians must implement new guidelines 143
CHAPTER 7 IMPROVING TREATMENT OUTCOMES 145
Treatment satisfaction in psoriatic arthritis 146
Japanese dermatologists show dissatisfaction with current treatments, but satisfaction is otherwise moderate 146
Unmet needs in psoriatic arthritis 147
Physicians treating psoriatic arthritis prioritize improved disease modification 147
Treatment satisfaction in ankylosing spondylitis 148
Rheumatologists in Japan show dissatisfaction with current treatments, although satisfaction is moderate across the seven major markets 148
Unmet needs in ankylosing spondylitis 151
Improved disease modification is seen as critical to the progression of ankylosing spondylitis treatment 151
BIBLIOGRAPHY 154
Journal papers 154
Websites 166
APPENDIX A 168
Physician research methodology 168
Contributing experts 168
APPENDIX B 169
The survey questionnaire 169
About Datamonitor 184
About Datamonitor Healthcare 184
About the Inflammation and Immunology analysis team 185
Disclaimer 186
List of Tables
Table 1: Rheumatologists surveyed regarding psoriatic arthritis and ankylosing spondylitis, 2008 11
Table 2: Dermatologists surveyed regarding psoriatic arthritis, 2008 11
Table 4: Psoriatic arthritis population across the seven major markets, split by disease severity, (%), 2008 37
Table 5: The 2006 ClASsification criteria for Psoriatic ARthritis (CASPAR) system summary 38
Table 6: Ankylosing spondylitis population across the seven major markets, 2008 42
Table 7: Key ankylosing spondylitis prevalence studies in selected countries, 1979-2008 43
Table 8: Ankylosing spondylitis population across the seven major markets, split by disease severity (%), 2008 51
Table 9: Mean percentage of ankylosing spondylitis patients suffering from the disease at each additional anatomical site across the seven major markets, 2008 52
Table 10: Psoriatic arthritis patients initially experiencing psoriasis versus systemic joint inflammation in the seven major markets (%), 2008 56
Table 11: Mean percentage of psoriatic arthritis sufferers who are diagnosed versus undiagnosed in the seven major markets, 2008 60
Table 12: Total length of time from onset of symptoms to psoriatic arthritis diagnosis across the seven major markets, 2008 63
Table 13: Presentation, diagnosis, treatment initiation, and long-term management of psoriatic arthritis by physician type across the seven major markets (%), 2008 66
Table 14: Mean percentage of psoriatic arthritis patients initially presenting to each physician type across the seven major markets, 2008 70
Table 15: Mean percentage of psoriatic arthritis patients diagnosed by each physician type across the seven major markets, 2008 73
Table 16: Mean percentage of psoriatic arthritis patients receiving treatment initiation by each physician type, across the seven major markets, 2008 76
Table 17: Mean percentage of psoriatic arthritis patients receiving long-term management by each physician type across the seven major markets, 2008 79
Table 18: Total length of time from onset of symptoms to ankylosing spondylitis diagnosis across the seven major markets, 2008 85
Table 19: Presentation, diagnosis, treatment initiation, and long-term management of ankylosing spondylitis by physician type across the seven major markets, 2008 90
Table 20: Mean percentage of ankylosing spondylitis patients presenting to each physician type across the seven major markets, 2008 92
Table 21: Mean percentage of ankylosing spondylitis patients diagnosed by each physician type across the seven major markets, 2008 94
Table 22: Mean percentage of ankylosing spondylitis patients receiving treatment initiation by each physician type across the seven major markets, 2008 96
Table 23: Mean percentage of ankylosing spondylitis patients receiving long-term management by each physician type across the seven major markets, 2008 97
Table 24: Percentage of psoriatic arthritis patients receiving pharmacological and non-pharmacological therapy, by disease severity across the seven major markets, 2008 107
Table 25: Percentage of ankylosing spondylitis patients receiving pharmacological and non-pharmacological therapy, by disease severity across the seven major markets, 2008 112
Table 26: Analgesic (i.e., acetaminophen) class usage in psoriatic arthritis by disease severity, across the seven major markets, 2008 115
Table 27: Analgesic (i.e., acetaminophen) class usage in ankylosing spondylitis by disease severity, across the seven major markets, 2008 116
Table 28: NSAID (i.e., naproxen, ibuprofen) class usage in psoriatic arthritis by disease severity across the seven major markets, 2008 118
Table 29: COX-2 inhibitor (i.e., celecoxib) class usage in psoriatic arthritis by disease severity, across the seven major markets, 2008 119
Table 30: NSAID (i.e., naproxen, ibuprofen) class usage in ankylosing spondylitis by disease severity across the seven major markets, 2008 120
Table 31: COX-2 inhibitor (i.e., celecoxib) class usage in ankylosing spondylitis by disease severity across the seven major markets, 2008 121
Table 32: Systemic corticosteroid (oral, intravenous, intramuscular and intra-articular) class usage in psoriatic arthritis by disease severity across the seven major markets, 2008 122
Table 33: Systemic corticosteroid (oral, intravenous, intramuscular and intra-articular) class usage in ankylosing spondylitis by disease severity across the seven major markets, 2008 124
Table 34: Systemic immunosuppressant (i.e. azathioprine, mycophenolate mofetil) class usage in psoriatic arthritis by disease severity across the seven major markets, 2008 126
Table 35: Systemic immunosuppressant (i.e. methotrexate, azathioprine, mycophenolate mofetil) class usage in ankylosing spondylitis by disease severity, across the seven major markets, 2008 127
Table 36: Traditional DMARD (i.e., leflunomide, sulfasalazine) class usage in psoriatic arthritis by disease severity, across the seven major markets, 2008TypeTableTitleHere 128
Table 37: Traditional DMARD (i.e., leflunomide, sulfasalazine) class usage in psoriatic ankylosing spondylitis by disease severity across the seven major markets, 2008 130
Table 38: Anti-TNF (i.e., etanercept, infliximab) class usage in psoriatic arthritis by disease severity across the seven major markets, 2008TypeTableTitleHere 132
Table 39: Anti-TNF (i.e., etanercept, infliximab) class usage in ankylosing spondylitis by disease severity across the seven major markets, 2008 136
Table 40: Topical NSAID (i.e., diclofenac) class usage in psoriatic arthritis by disease severity across the seven major markets, 2008TypeTableTitleHere 137
Table 41: Topical vitamin derivative (i.e. calcipotriol) class usage in psoriatic arthritis by disease severity across the seven major markets, 2008TypeTableTitleHere 138
Table 42: Topical corticosteroid class usage in psoriatic arthritis by disease severity across the seven major markets, 2008TypeTableTitleHere 139
Table 43: Topical immunomodulator (i.e., pimecrolimus, tacrolimus) class usage in psoriatic arthritis by disease severity across the seven major markets, 2008 141
Table 44: Cytotoxic agent (i.e., ciclosporin, cyclophosphamide) class usage in psoriatic arthritis by disease severity, across the seven major markets, 2008 143
List of Figures
Figure 1: US psoriatic arthritis patient population split by physician-estimated diagnoses, disease severity, drug-treated population, and drug-class usage, 2008 13
Figure 2: Japan psoriatic arthritis patient population split by physician-estimated diagnoses, disease severity, drug-treated population, and drug-class usage, 2008 14
Figure 3: France psoriatic arthritis patient population split by physician-estimated diagnoses, disease severity, drug-treated population, and drug-class usage, 2008 15
Figure 4: Germany psoriatic arthritis patient population split by physician-estimated diagnoses, disease severity, drug-treated population, and drug-class usage, 2008 16
Figure 5: Italy psoriatic arthritis patient population split by physician-estimated diagnoses, disease severity, drug-treated population, and drug-class usage, 2008 17
Figure 6: Spain psoriatic arthritis patient population split by physician-estimated diagnoses, disease severity, drug-treated population, and drug-class usage, 2008 18
Figure 7: UK psoriatic arthritis patient population split by physician-estimated diagnoses, disease severity, drug- treated population, and drug-class usage, 2008 19
Figure 8: US ankylosing spondylitis patient population split by physician-estimated diagnoses, disease severity, drug-treated population, and drug-class usage, 2008 20
Figure 9: Japan ankylosing spondylitis patient population split by physician-estimated diagnoses, disease severity, drug-treated population, and drug-class usage, 2008 21
Figure 10: France ankylosing spondylitis patient population split by physician-estimated diagnoses, disease severity, drug-treated population, and drug-class usage, 2008 22
Figure 11: Germany ankylosing spondylitis patient population split by physician-estimated diagnoses, disease severity, drug-treated population, and drug-class usage, 2008 23
Figure 12: Italy ankylosing spondylitis patient population split by physician-estimated diagnoses, disease severity, drug-treated population, and drug-class usage, 2008 24
Figure 13: Spain ankylosing spondylitis patient population split by physician-estimated diagnoses, disease severity, drug-treated population, and drug-class usage, 2008 25
Figure 14: UK ankylosing spondylitis patient population split by physician-estimated diagnoses, disease severity, drug-treated population, and drug-class usage, 2008 26
Table 3: Psoriatic arthritis prevalence across the seven major markets, 2008 31
Figure 15: Total psoriatic arthritis population in the seven major markets, split by disease severity, 2008 36
Figure 16: Total ankylosing spondylitis population in the seven major markets, split by disease severity, 2008 50
Figure 17: Mean percentage of ankylosing spondylitis patients suffering from the disease at each additional anatomical site across the seven major markets, 2008 52
Figure 18: Psoriatic arthritis patients initially experiencing psoriasis versus systemic joint inflammation in the seven major markets (%), 2008 57
Figure 19: Mean percentage of psoriatic arthritis sufferers who are diagnosed versus undiagnosed in the seven major markets, 2008 59
Figure 20: Total length of time from onset of symptoms to psoriatic arthritis diagnosis across the seven major markets, 2008 62
Figure 21: Presentation, diagnosis, treatment initiation, and long-term management of psoriatic arthritis by physician type across the seven major markets, 2008 65
Figure 22: Mean percentage of psoriatic arthritis patients initially presenting to each physician type across the seven major markets, 2008 69
Figure 23: Mean percentage of psoriatic arthritis patients diagnosed by each physician type across the seven major markets, 2008 72
Figure 24: Mean percentage of psoriatic arthritis patients receiving treatment initiation by each physician type across the seven major markets, 2008 75
Figure 25: Mean percentage of psoriatic arthritis patients receiving long-term management by each physician type across the seven major markets, 2008 78
Figure 26: Ankylosing spondylitis diagnosis rates across the seven major markets, 2008 81
Figure 27: Total length of time from onset of symptoms to ankylosing spondylitis diagnosis across the seven major markets, 2008 84
Figure 28: Presentation, diagnosis, treatment initiation, and long-term management of ankylosing spondylitis by physician type across the seven major markets, 2008 90
Figure 29: Mean percentage of ankylosing spondylitis patients presenting to each physician type across the seven major markets, 2008 92
Figure 30: Mean percentage of ankylosing spondylitis patients diagnosed by each physician type across the seven major markets, 2008 94
Figure 31: Mean percentage of ankylosing spondylitis patients receiving treatment initiation by each physician type across the seven major markets, 2008 95
Figure 32: Mean percentage of ankylosing spondylitis patients receiving long-term management by each physician type across the seven major markets, 2008 97
Figure 33: Rheumatologists: percentage of psoriatic arthritis patients receiving pharmacological and non-pharmacological therapy, by disease severity across the seven major markets, 2008 105
Figure 34: Dermatologists: percentage of psoriatic arthritis patients receiving pharmacological and non-pharmacological therapy, by disease severity across the seven major markets, 2008 106
Figure 35: Rheumatologists: drug class usage in psoriatic arthritis by disease severity across the seven major markets, 2008 109
Figure 36: Dermatologists: drug class usage in psoriatic arthritis by disease severity across the seven major markets, 2008 110
Figure 37: Percentage of ankylosing spondylitis patients receiving pharmacological and non-pharmacological therapy, by disease severity across the seven major markets, 2008 111
Figure 38: Drug class usage in ankylosing spondylitis by disease severity across the seven major markets, 2008 114
Figure 39: Rheumatologists' and dermatologists' satisfaction with currently available psoriatic arthritis treatments across the seven major markets, 2008 146
Figure 40: Priority rating allocated by rheumatologists to unmet needs in the pharmacological treatment of psoriatic arthritis, 2008 147
Figure 41: Rheumatologists' satisfaction with currently available ankylosing spondylitis treatments across the seven major markets, 2008 149
Figure 42: Priority rating allocated by rheumatologists to unmet needs in the pharmacological treatment of ankylosing spondylitis, 2008 152
