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Stakeholder Insight: Psoriasis - Biologics are yet to make topical treatments obsolete

ABOUT DATAMONITOR HEALTHCARE 2
About the Immunology & Inflammation pharmaceutical analysis team 2

CHAPTER 1 EXECUTIVE SUMMARY 3
Scope of the analysis 3
Datamonitor insight into the psoriasis market 4
Contributing experts 5
Related reports 6
Upcoming related reports 6

CHAPTER 2 INTRODUCTION AND SCOPE 8
Coverage of the Stakeholder Insight Survey 8
Epidemiology and comorbidities of psoriasis 8
Patient segmentation, presentation and diagnosis 8
Treatment options and trends 8
Brand trends 9
Improving treatment outcomes 9
Future trends 9

CHAPTER 3 COUNTRY TREATMENT TREES 10
Introduction to treatment trees 10
US 11
Japan 13
France 14
Germany 16
Italy 18
Spain 20
UK 22

CHAPTER 4 EPIDEMIOLOGY AND COMORBIDITIES OF PSORIASIS 24
Disease definition and types 25
Plaque psoriasis affects the majority of psoriasis patients 26
Diagnostic criteria 28
Epidemiology of psoriasis 29
Studies of psoriasis prevalence in the US broadly align with each other 30
Psoriasis prevalence in Japan is lower than in the US and Europe 30
Europe 31
Estimates of psoriasis prevalence in France vary widely 31
German psoriasis prevalence estimates lead to a consensus figure 31
Two prevalence studies in Italy reach similar conclusions 32
Spanish psoriasis prevalence estimates vary within a narrow range 32
Two studies find similar psoriasis prevalence rates in the UK 32
Trends in psoriasis epidemiology 33
Psoriasis typically affects adolescents and middle-aged adults 33
Psoriasis affects slightly more men than women 34
Comorbidities, risk factors and complications 34
Comorbidities are common in psoriasis 34
Obesity and smoking are strongly associated with psoriasis 39
Physical trauma and infections can bring on psoriasis 40
Other autoimmune diseases affect over 20% of psoriasis patients with a comorbidity 40

CHAPTER 5 PATIENT SEGMENTATION, PRESENTATION AND DIAGNOSIS 42
Psoriasis diagnosis rates and awareness are relatively low 43
Reasons for the low diagnosis rates 45
Disease severity drives treatment-seeking behavior 45
Time to diagnosis 48
Many psoriasis patients wait over 10 months before presenting 48
Psoriasis diagnosis tends not to be immediate 50
Physicians do not perceive misdiagnosis as a key reason for lack of psoriasis diagnosis 51
Patient segmentation 51
The majority of psoriasis patients have mild or moderate disease 52

CHAPTER 6 TREATMENT OPTIONS AND TRENDS 56
Treatment guidelines 57
Various national treatment guidelines are interpreted and applied internationally 57
Non-pharmacological, pharmacological and combination treatment strategies 57
Non-pharmacological therapies 60
Phototherapy: principles and potential risks 62
Phototherapy usage is low in most markets 64
Excimer laser 68
Psoralen plus UVA (PUVA) 68
Ultraviolet light B 69
Sunlight 71
Balneophototherapy 72
Pharmacological therapies 74
Topical and systemic therapies 74
Use of systemic and combination therapy increases with disease severity 74
Treatment class options and trends 76
Topical vitamin derivatives 77
Topical vitamin derivative use is common in mild to moderate psoriasis 77
Cytotoxic agents 78
Cytotoxic agents may be used instead of biologics in moderate to severe psoriasis 79
Systemic corticosteroids 80
Systemic corticosteroids are used nearly exclusively in severe psoriasis 80
Topical corticosteroids 81
Topical corticosteroid use varies significantly from market to market 81
Immunosuppressants 82
Immunosuppressant usage relies on situation-specific cost-benefit analysis 83
Topical immunomodulators 84
Topical immunomodulators see limited off-label use in psoriasis 84
Systemic retinoids 85
Biologic therapy 87
The market for anti-TNF therapy in moderate to severe psoriasis is maturing 87
Less than 10% of severe psoriasis patients use other biologic drugs 88
Other drug classes 89
Analgesics are used sparingly in psoriasis 89
NSAIDs and COX-2 inhibitors are used sparingly to manage inflammation 90
Topical NSAIDs are uncommon in psoriasis treatment regardless of disease severity 91
Traditional DMARDs are rarely used in psoriasis 92

CHAPTER 7 BRAND TRENDS 94
Biologic usage by brand, line and response dynamics 95
Usage of biologic brands by percentage 95
Overall Enbrel is currently the predominant brand in psoriasis 97
Preference by line of therapy 98
Physicians strongly prefer Enbrel at first line 99
Humira shines at second line in the US but opinion is split in Europe 99
Remicade and Raptiva are the clear favorites at third line 99
Outcomes by brand of biologic 100
Enbrel is preferred at first line but fails for a significant proportion of patients 100
Importance of prescribing factors 103
Question design 103
Efficacy and safety are important to all classes 103
Disease modification is the primary rationale for biologics use 105
Side-effect profile comparatively more important for vitamin derivatives 106
Speed of action dictates the prescribing decision for steroids 107
Physician perception of key brands 108
Amevive (alefacept; Astellas, Biogen Idec) 111
Amevive: poorly understood or differentiated 112
Raptiva (efalizumab; Genentech, Xoma, Merck Serono) 113
Cases of PML spell trouble for Raptiva 113
Dermatologists rated Raptiva highly in terms of dosing frequency 113
Raptiva's safety profile continues to signal doom for the brand 114
Enbrel (etanercept; Amgen, Wyeth) 115
Enbrel loses out in terms of disease modification efficacy 116
Remicade (infliximab; Centocor, Schering-Plough, Mitsubishi Tanabe) 117
Remicade used for speed of action in more severe patients 117
Remicade's downfall in psoriasis is its method of administration 118
Humira (adalimumab; Abbott, Eisai) 119
Humira scores well on dose frequency, but loses out on top spot to Stelara for this attribute 119
Humira market share predicted to increase due to positive perception 120
Stelara (ustekinumab; Centocor, Janssen Cilag) 121
Fewer dermatologists were able to rate Stelara, but overall scores were high 121
Stelara awarded higher scores than other biologics on efficacy attributes 122
Stelara's perceived speed of action is similar to Humira but lower than Remicade 124
Stelara's dosing frequency sets it apart from other biologic brands 125
Dovonex (calcipotriol; Leo Pharma, Warner Chilcott) 125
Dovonex combines well with other therapies and rates positively in reimbursement status 126
Elocon (mometasone; Schering-Plough) 127
Elocon received similar attribute scores to Dovonex 127

CHAPTER 8 IMPROVING TREATMENT OUTCOMES 129
Measuring the severity of psoriasis 130
PASI score is the standard endpoint in psoriasis clinical research 130
In the EU, payers have an influence on clinical usage of the PASI scores 131
Dermatologists generally accept PASI 75, but some prefer PASI 50 133
Most physicians using PASI clinically aim for a PASI score of 5 to 10 136
Other measures of treatment efficacy in psoriasis 137
Achieving treatment outcomes 140
Most mild patients reach desired outcomes after six months of treatment 140
Treatment satisfaction in psoriasis 143
Satisfaction with current psoriasis treatments is moderate to high 143
Unmet needs in psoriasis 144
Better formulations to increase adherence and tools to improve prescribing 144
BIBLIOGRAPHY 147
Journal papers 147
Websites 156
Datamonitor reports 158

APPENDIX A 159
Physician research methodology 159

APPENDIX B 160
The survey questionnaire 160
About Datamonitor 183
About Datamonitor Healthcare 183
About the Immunology & Inflammation analysis team 184
Disclaimer 185

List of Tables
Table 1: Subtypes of psoriasis, percentage of diagnosed patients across the seven major markets, 2008 27
Table 2: Features that have been considered in different classifications of psoriasis 28
Table 3: Psoriasis prevalence across the seven major markets, 2008 30
Table 4: Percentages of psoriasis patients with selected comorbidities in the seven major markets, 2004 and 2008 37
Table 5: Selected additional common psoriasis comorbidities, percentage of diagnosed patients across the seven major markets, 2008 38
Table 6: Autoimmune psoriasis comorbidities, percentage of patients with a comorbidity, across the seven major markets, 2008 41
Table 7: Percentage of psoriasis sufferers diagnosed in the seven major markets, 2004 and 2008 44
Table 8: Mean rating given to each reason for patients remaining undiagnosed, 5 = strongly agree,, seven major markets, 2008 46
Table 9: Total length of time from onset of symptoms to psoriasis diagnosis across the seven major markets (months) 2008 49
Table 10: Percentage of diagnosed psoriasis patients by disease severity in the seven major markets, 2008 54
Table 11: Treatment strategies recommended to psoriasis patients across the seven major markets, by disease severity, 2008 60
Table 12: Percentage of patients estimated to use non-pharmacological therapy only, by disease severity and country, 2008 62
Table 13: Types of phototherapy used by patients receiving phototherapy for psoriasis, by country, 2008 67
Table 14: Mean percentages of psoriasis patients estimated to use treatment options, by disease severity, per country, 2008 75
Table 15: Overview of drug classes commonly used in psoriasis treatment in the seven major markets, 2008 76
Table 16: Topical vitamin derivative class usage in psoriasis by disease severity across the seven major markets, 2008 78
Table 17: Cytotoxic agent class usage in psoriasis by disease severity across the seven major markets, 2008 79
Table 18: Systemic corticosteroid class usage in psoriasis by disease severity across the seven major markets, 2008 81
Table 19: Topical corticosteroid class usage in psoriasis by disease severity, across the seven major markets, 2008 82
Table 20: Immunosuppressant class usage in psoriasis by disease severity, across the seven major markets, 2008 84
Table 21: Topical immunomodulators class usage in psoriasis by disease severity and patients with inverse psoriasis across the seven major markets, 2008 85
Table 22: Systemic retinoid class usage in psoriasis by disease severity across the seven major markets, 2008 86
Table 23: Anti-TNF class usage in psoriasis by disease severity across the seven major markets, 2008 88
Table 24: Other biologics usage in psoriasis by disease severity across the seven major markets, 2008 89
Table 25: Analgesic usage in psoriasis by disease severity across the seven major markets, 2008 90
Table 26: Traditional systemic NSAID class usage in psoriasis by disease severity across the seven major markets, 2008 91
Table 27: COX-2 class usage in psoriasis by disease severity across the seven major markets, 2008 91
Table 28: Topical NSAID class usage in psoriasis by disease severity across the seven major markets, 2008 92
Table 29: DMARD class usage in psoriasis by disease severity across the seven major markets, 2008 93
Table 30: Percentage use by brand, for all patients receiving biologic therapy in the seven major markets, 2008 96
Table 31: Percentage of patients receiving each biologic brand with an initial inadequate response and who eventually become refractory 102
Table 32: Comparative importance of factors affecting dermatologist prescribing decisions, by country, for biologics 105
Table 33: Comparison of PASI 50, -75 and -90 scores between the biologic brands 106
Table 34: Comparative importance of factors affecting dermatologist prescribing decisions, by country, for vitamin derivatives 107
Table 35: Comparative importance of factors affecting dermatologist prescribing decisions, by country, for steroids 108
Table 36: Comparative scores across all brands assessed 111
Table 37: Amevive scores by attribute and country 112
Table 38: Raptiva scores by attribute and country 114
Table 39: Enbrel scores by attribute and country 116
Table 40: Remicade scores by attribute and country 118
Table 41: Humira scores by attribute and country 120
Table 42: Stelara scores by attribute and country 122
Table 43: Dovonex scores by attribute and country 127
Table 44: Elocon scores by attribute and country 128
Table 45: Percentages for successful PASI change across the seven major markets, 2008 135
Table 46: Percentages for minimum successful PASI change across the seven major markets, 2008 136
Table 47: Measures of treatment efficacy in psoriasis among physicians not using PASI score in clinical practice, 2008 139
Table 48: Percentage of patients reaching the desired outcome after 6 months of treatment, % 141
Table 49: Priority rating allocated by dermatologists to unmet needs in the treatment of psoriasis, 1=low priority, 2008 145
Table 50: Dermatologists surveyed regarding psoriasis, 2008 159

List of Figures
Figure 1: Psoriasis patient population, split by physician-estimated diagnoses, disease severity, drug-treated population and drug-class usage in the US, 2008 11
Figure 2: Preferred biologic drug brands by line of therapy in moderate to severe psoriasis in the US, 2008 12
Figure 3: Psoriasis patient population, split by physician-estimated diagnoses, disease severity, drug-treated population and drug-class usage in Japan, 2008 13