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Psoriasis - Biologics are yet to make topical treatments obsolete

Introduction

Patient perception of disease severity drives treatment-seeking behavior in psoriasis. New therapeutic options targeting specific mechanisms are set to reshape severe psoriasis therapy. However, current biologics have not undermined first-line topical therapy. In addition to efficacy, reimbursement plays a crucial role in physicians' prescribing decisions.

Scope

Opinion from 180 practicing dermatologists, each treating at least 40 psoriasis patients per month

Including data from physicians and opinion leaders across the seven major markets of the US, Japan, France, Germany, Spain, Italy and the UK

Analysis of psoriasis population attributes, physicians' prescribing decisions, therapy outcomes and treatment satisfaction

Brand analysis of key pharmaceuticals used in psoriasis, including biologics and branded topical formulations

Highlights

The low estimated diagnosis rate of 54% reflects a lack of treatment-seeking by mild sufferers. Despite nearly 10 million diagnosed patients, the market value of psoriasis is constrained by reliance on generic and non-prescription treatments in mild disease.

Biologics' risk-benefit and cost-benefit ratios are coming under review. Humira (adalimumab) and Stelara (ustekinumab) stand to benefit from the withdrawal of Raptiva (efalizumab) from the EU and more stringent labeling in the US. The position of biologics in moderate to severe psoriasis is up for challenge by payers attempting to control costs.

Topical treatments are the foundation of therapy, used alone by at least 82% of mild patients. Phototherapy is a cost-effective treatment option in psoriasis unresponsive to topical therapy. Most physicians surveyed recommend phototherapy to up to 30% of patients, and payers may influence greater use of phototherapy.

Reasons to Purchase

Understand how patient behavior controls the size of the psoriasis market

Interpret physicians' priorities in prescribing personalized psoriasis treatment regimens

Assess the regional dynamics of therapy choice in psoriasis, dictated by product availability, regulation and reimbursement

Table of Contents

CHAPTER 1 EXECUTIVE SUMMARY 3

• Scope of the analysis 3
• 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

APPENDIX A 159

• Physician research methodology 159

APPENDIX B 160

• The survey questionnaire 160

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
• Figure 4: Psoriasis patient population, split by physician-estimated diagnoses, disease severity, drug-treated population and drug-class usage in France, 2008 14
• Figure 5: Preferred biologic drug brands by line of therapy in moderate to severe psoriasis in France, 2008 15
• Figure 6: Psoriasis patient population, split by physician-estimated diagnoses, disease severity, drug-treated population and drug-class usage in Germany, 2008 16
• Figure 7: Preferred biologic drug brands by line of therapy in moderate to severe psoriasis in Germany, 2008 17
• Figure 8: Psoriasis patient population, split by physician-estimated diagnoses, disease severity, drug-treated population and drug-class usage in Italy, 2008 18
• Figure 9: Preferred biologic drug brands by line of therapy in moderate to severe psoriasis in Italy, 2008 19
• Figure 10: Psoriasis patient population, split by physician-estimated diagnoses, disease severity, drug-treated population and drug-class usage in Spain, 2008 20
• Figure 11: Preferred biologic drug brands by line of therapy in moderate to severe psoriasis in Spain, 2008 21
• Figure 12: Psoriasis patient population, split by physician-estimated diagnoses, disease severity, drug-treated population and drug-class usage in the UK, 2008 22
• Figure 13: Preferred biologic drug brands by line of therapy in moderate to severe psoriasis in the UK, 2008 23
• Figure 14: Subtypes of psoriasis, percentage of diagnosed patients across the seven major markets, 2008 27
• Figure 15: Mean percentage of psoriasis patients with at least one comorbidity in the seven major markets, 2008 34
• Figure 16: Percentage of psoriasis patients with selected comorbidities in the seven major markets, 2004 and 2008 36
• Figure 17: Selected additional common psoriasis comorbidities, percentage of diagnosed patients across the seven major markets, 2008 38
• Figure 18: Autoimmune psoriasis comorbidities, percentage of patients with a comorbidity, across the seven major markets, 2008 41
• Figure 19: Percentage of diagnosed versus undiagnosed psoriasis sufferers in the seven major markets, 2008 43
• Figure 20: Total estimated psoriasis patient population, diagnosed versus undiagnosed, in the seven major markets, 2008 45
• Figure 21: Mean rating given to each reason for patients remaining undiagnosed, seven major markets, 2008 46
• Figure 22: Total length of time from onset of symptoms to psoriasis diagnosis across the seven major markets, 2008 49
• Figure 23: Physicians indicating that psoriasis is diagnosed immediately upon presentation versus those who believe that patients experience a delay in receiving a diagnosis, 2008 50
• Figure 24: Percentage of diagnosed psoriasis patients by disease severity in the seven major markets, 2008 53
• Figure 25: Treatment strategies used by psoriasis patients across the seven major markets, by disease severity, 2008 59
• Figure 26: Percentage of patients estimated to use non-pharmacological therapy strategies, by disease severity, across the seven major markets, 2008 61
• Figure 27: Percentage of patients estimated to use non-pharmacological therapy only, by disease severity and country, 2008 62
• Figure 28: Mean estimated percentages of patients recommended to use phototherapy, by country, 2008 64
• Figure 29: Distribution of percentages of patients to whom phototherapy is recommended in the seven major markets, 2008 66
• Figure 30: Types of phototherapy used by patients receiving phototherapy for psoriasis, by country, 2008 67
• Figure 31: Mean percentages of psoriasis patients estimated to use topical and/or systemic treatment options, by disease severity, across the seven major markets, 2008 74
• Figure 32: Percentage use by brand, for all patients receiving biologic therapy in the seven major markets, 2008, 96
• Figure 33: Preferred biologic drug brands by line of therapy in moderate to severe psoriasis, US verses average of five major EU counties, 2008 98
• Figure 34: Percentage of patients receiving each biologic brand with an initial inadequate response and who eventually become refractory 101
• Figure 35: Comparative importance of factors affecting dermatologist prescribing decisions, by class 104
• Figure 36: Comparative scores across all brands assessed 110
• Figure 37: Stelara's clinical response between Week 0 and Week 28 124
• Figure 38: Percentage of physicians using the PASI score across the seven major markets, 2008 132
• Figure 39: Successful percentage of PASI change across the seven major markets, 2008 134
• Figure 40: Successful minimum PASI change, %, across the seven major markets, 2008 134
• Figure 41: Physicians stating 41%-50%, 61%-70% and 71%-80% as acceptable PASI scores, by country, 2008 135
• Figure 42: Mean PASI scores physicians aim to reach in the seven major markets, 2008 137
• Figure 43: Measures of treatment efficacy in psoriasis among physicians not using PASI score in clinical practice, seven major markets, 2008 138
• Figure 44: Measures of treatment efficacy in psoriasis among US physicians not using PASI score in clinical practice, 2008 140
• Figure 45: Distribution of physician responses for percentage of patients reaching the desired outcome, by severity 142
• Figure 46: Dermatologists' satisfaction with currently available psoriasis treatments across the seven major markets, 2008 143
• Figure 47: Distribution of dermatologists' ratings of satisfaction with currently available psoriasis treatments across the seven major markets, 2008 144
• Figure 48: Priority rating allocated by dermatologists to unmet needs in the treatment of psoriasis, 2008 145

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