Rheumatoid Arthritis - Biologics battle up the treatment algorithm
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
- Scope of the analysis - page 3
- Datamonitor insight into the rheumatoid arthritis market - page 4
- CHAPTER 2 INTRODUCTION AND SCOPE - page 12
- What is rheumatoid arthritis (RA)? - page 12
- How is it treated? - page 13
- Coverage of the Stakeholder Insight Survey - page 13
- Country level "treatment trees" - page 15
- Supporting data sets - page 15
- CHAPTER 3 COUNTRY TREATMENT TREES - page 17
- US - page 18
- Japan - page 21
- France - page 24
- Germany - page 27
- Italy - page 30
- Spain - page 33
- UK - page 36
- CHAPTER 4 EPIDEMIOLOGY AND PATIENT SEGMENTATION - page 39
- Definition of the disease - page 39
- Epidemiology of rheumatoid arthritis - page 39
- Key patient segmentations - page 42
- Disease severity shows an even split among mild and moderate disease, with fewer severe patients - page 42
- Early active RA should be defined as less than one-year duration for maximum patient benefit - page 43
- Co-morbidities, complications and risk factors - page 46
- Hypertension, elevated cholesterol and, to a lesser extent, heart attacks are common in RA patients - page 48
- Osteoporosis is also common, but likely to be due to long-term steroid use - page 50
- Depression is two to three times greater in RA patients than in the general population - page 50
- Other co-morbidities include additional autoimmune diseases and stomach ulcers - page 51
- CHAPTER 5 DIAGNOSIS AND TREATMENT OPTIONS - page 52
- Presentation and diagnosis lower than in previous Datamonitor surveys - page 52
- Treatment types - page 54
- Pharmacological and non-pharmacological therapy is often used in combination for moderate and severe patients - page 54
- Use of combination drug therapy also increases with severity - page 55
- NSAIDs, analgesics and traditional DMARDs are the most commonly prescribed drug classes - page 57
- Treatment options - page 60
- Treatment guidelines - page 61
- Referral patterns - page 63
- Direct consultation, or referral, for rheumatologists? - page 64
- The next referral move - page 64
- CHAPTER 6 PRESCRIBING TRENDS - page 68
- NSAID prescribing trends - page 68
- The most commonly-used NSAID molecule is diclofenac - page 68
- Use of NSAIDs and COX-2s since the withdrawal of Vioxx - page 69
- High, and possibly inappropriate, co-prescription of a gastro-protective agent with NSAIDs - page 75
- Use of NSAIDs before and in combination with DMARDs - page 78
- Traditional DMARD prescribing trends - page 80
- Methotrexate most commonly used as first-line therapy - page 85
- Infection and inadequate response are the main reasons for switching - page 85
- NSAID prescribing trends - page 68
- CHAPTER 7 BRAND ASSESSMENT - page 88
- Factors influencing physician decision making - page 88
- Disease modification and side-effects are the most important factors to prescribing physicians - page 88
- Disease modification - page 91
- Side effects - page 94
- Speed of action and pain relief - page 95
- Formulary or reimbursement status - page 99
- Dosing frequency and delivery method - page 100
- Ability to combine - page 101
- Ability to treat co-morbidities - page 102
- Compliance - page 102
- Disease modification and side-effects are the most important factors to prescribing physicians - page 88
- Biologic DMARD brand assessment - page 104
- Biologic DMARD overview shows Enbrel leads in terms of total brand sales for all indications - page 104
- Interpreting a brand map - page 107
- As the gold standard traditional DMARD, methotrexate is used to benchmark the biologic treatments - page 109
- The three available anti-TNFs are perceived to be similar - page 110
- Brand comparison shows Humira and Enbrel lead the group - page 112
- Enbrel (etanercept) - page 112
- Remicade (infliximab) - page 115
- Humira (adalimumab) - page 118
- Kineret (anakinra) - page 121
- Orencia (abatacept) - page 123
- Rituxan/MabThera (rituximab) - page 125
- Factors influencing physician decision making - page 88
- CHAPTER 8 IMPROVING TREATMENT OUTCOMES - page 129
- Treatment outcomes - page 129
- Outcome measure definitions - page 129
- American College of Rheumatology 20, 50 and 70 - page 129
- Disease activity scale - page 130
- Visual analogue scale - page 131
- Erythrocyte sedimentation rate - page 131
- C-reactive protein - page 132
- Global Assessment - page 132
- Health assessment questionnaire - page 135
- Medical outcome short form 36 (SF-36) health survey - page 136
- Physician patient conversation is the most commonly used outcome measure in the clinic - page 136
- Expected outcome measures before and after anti-TNF treatment don't always correlate with published data - page 138
- Expectation versus published results - page 138
- Compliance rates improve with disease severity - page 143
- Outcome measure definitions - page 129
- Unmet needs - page 146
- Efficacy and side-effects are key, but other challenges should also be addressed by the pharmaceutical industry - page 146
- Treatment outcomes - page 129
- APPENDIX A - page 152
- Bibliography - page 152
- Other sources and websites - page 156
- Bibliography - page 152
- APPENDIX B - page 157
- Physician research methodology - page 157
- Physician sample breakdown - page 157
- US - page 157
- Japan - page 157
- France - page 158
- Germany - page 158
- Italy - page 158
- Spain - page 159
- UK - page 159
- Contributing experts - page 159
- Physician research methodology - page 157
- APPENDIX C - page 160
- The survey questionnaire - page 160
- Section 1: Epidemiology - page 160
- Section 2: Treatment classes and disease severity - page 164
- Section 3: Prescribing factors - page 169
- Section 4: Prescribing patterns - page 171
- Section 5: Treatment outcomes - page 177
- Disclaimer - page 181
- The survey questionnaire - page 160
- List of Tables
- Table 1: RA patient population, 2006 - page 40
- Table 2: Point prevalence of RA, by age and sex, per 100 patients in Norfolk UK study, 2002 - page 41
- Table 3: Estimated RA population based on population aged >60: CAGR for each country, 2005-2030 - page 42
- Table 4: RA disease severity as a percentage of total diagnosed RA population, by country - page 43
- Table 5: Physician-estimated proportion of patients defined has having early active RA, by country - page 44
- Table 6: Proportion of patients defined has having early active RA, by physician specialty - page 45
- Table 7: Percentage of RA patients with each co-morbidity, by country - page 48
- Table 8: Diagnosed RA patients, physician-estimated, by country - page 52
- Table 9: Number of months from symptom onset to presentation to physician - page 53
- Table 10: Percent of patients receiving pharmacological versus non-pharmacological treatment, by country - page 54
- Table 11: Pharmacological versus non-pharmacological treatment, by physician specialty and percentage of diagnosed patients - page 55
- Table 12: Percentage of patients on each number of drugs, by severity and by country - page 56
- Table 13: Percentage of patients receiving each drug class, by severity - page 57
- Table 14: Number of physicians using each set of guidelines, by physician specialty - page 61
- Table 15: Percentage of mild, moderate and severe RA patients referred on to another physician, by specialty - page 65
- Table 16: Percentage of physicians referring to each specialty, by country - page 67
- Table 17: Percentage of patients receiving each NSAID molecule, by severity - page 68
- Table 18: Action taken on traditional NSAID prescribing, percentage of physicians, by country, - page 73
- Table 19: Action taken on COX-2 prescribing, percentage of physicians, by country - page 74
- Table 20: Average length of time RA patients are given only an analgesic/ anti-inflammatory before being prescribed a DMARD, in months, by severity and country - page 79
- Table 21: Percentage of RA patients taking analgesic or anti-inflammatory treatment in addition to a DMARD, by severity and country - page 80
- Table 22: Percentage of patients on traditional DMARDs receiving key molecules, by country and severity - page 83
- Table 23: Number and percentage of physicians able to rate each brand - page 91
- Table 24: Comparative erosion and joint space narrowing (JSN) scores after 12 months, found in prescribing information, by brand - page 92
- Table 25: Efficacy comparison among key brands - page 97
- Table 26: Key biologic brand characteristics - page 105
- Table 27: Methotrexate's attribute scores, by country - page 109
- Table 28: Enbrel's attribute scores, by country - page 113
- Table 29: Remicade's attribute scores, by country - page 116
- Table 30: Humira attribute scores, by country - page 119
- Table 31: Kineret attribute scores, by country - page 122
- Table 32: Orencia's attribute scores, by country - page 124
- Table 33: Rituxan/MabThera's attribute scores, by country - page 128
- Table 34: Healthy ESR values - page 132
- Table 35: Commonly used outcome measures, by country - page 137
- Table 36: Average expected outcome measures before and after anti-TNF therapy - page 138
- Table 37: Published anti-TNF impacts on key outcome measures - page 139
- Table 38: Average VAS before and after anti-TNF therapy - page 141
- Table 39: Rheumatologist estimates of 28 tender and swollen joint counts before and after anti-TNF therapy - page 143
- Table 40: Compliance estimates by disease severity - page 145
- Table 41: Importance of challenges facing the RA market, by country - page 148
- Table 42: US physician sample breakdown, 2006 - page 157
- Table 43: Japan physician sample breakdown, 2006 - page 157
- Table 44: France physician sample breakdown, 2006 - page 158
- Table 45: Germany physician sample breakdown, 2006 - page 158
- Table 46: Italy physician sample breakdown, 2006 - page 158
- Table 47: Spain physician sample breakdown, 2006 - page 159
- Table 48: UK physician sample breakdown, 2006 - page 159
- List of Figures
- Figure 1: Overview of the coverage of Stakeholder Insight: Rheumatoid Arthritis survey, 2006 - page 14
- Figure 2: US RA patient population, split by physician-estimated diagnoses, disease severity, drug-treated population and drug-class usage - page 18
- Figure 3: Key NSAID, traditional DMARD and biologic DMARD molecules used in the US, by disease severity - page 19
- Figure 4: US treatment algorithm from onset of symptoms to percentage reaching desired outcome, for NSAIDs and first- to fifth-line DMARDs, by disease severity - page 20
- Figure 5: Japan RA patient population, split by estimated diagnoses, disease severity, drug-treated population and drug-class usage - page 21
- Figure 6: Key NSAID, traditional DMARD and biologic DMARD molecules used in Japan, by disease severity - page 22
- Figure 7: Japanese treatment algorithm from onset of symptoms to percentage reaching desired outcome, for NSAIDs and first- to fifth-line DMARDs, by disease severity - page 23
- Figure 8: France RA patient population, split by physician-estimated diagnoses, disease severity, drug-treated population and drug-class usage - page 24
- Figure 9: Key NSAID, traditional DMARD and biologic DMARD molecules used in France, by disease severity - page 25
- Figure 10: France treatment algorithm from onset of symptoms to percentage reaching desired outcome, for NSAIDs and first- to fifth-line DMARDs, by disease severity - page 26
- Figure 11: Germany RA patient population, split by physician-estimated diagnoses, disease severity, drug-treated population and drug-class usage - page 27
- Figure 12: Key NSAID, traditional DMARD and biologic DMARD molecules used in Germany, by disease severity - page 28
- Figure 13: Germany treatment algorithm from onset of symptoms to percentage reaching desired outcome, for NSAIDs and first- to fifth-line DMARDs, by disease severity - page 29
- Figure 14: Italy RA patient population, split by physician-estimated diagnoses, disease severity, drug-treated population and drug-class usage - page 30
- Figure 15: Key NSAID, traditional DMARD and biologic DMARD molecules used in Italy, by disease severity - page 31
- Figure 16: Italy treatment algorithm from onset of symptoms to percentage reaching desired outcome, for NSAIDs and first- to fifth-line DMARDs, by disease severity - page 32
- Figure 17: Spain RA patient population, split by physician-estimated diagnoses, disease severity, drug-treated population and drug-class usage - page 33
- Figure 18: Key NSAID, traditional DMARD and biologic DMARD molecules used in Spain, by disease severity - page 34
- Figure 19: Spain treatment algorithm from onset of symptoms to percentage reaching desired outcome, for NSAIDs and first- to fifth-line DMARDs, by disease severity - page 35
- Figure 20: UK RA patient population, split by physician-estimated diagnoses, disease severity, drug-treated population and drug-class usage - page 36
- Figure 21: Key NSAID, traditional DMARD and biologic DMARD molecules used in UK, by disease severity - page 37
- Figure 22: UK treatment algorithm from onset of symptoms to percentage reaching desired outcome, for NSAIDs and first- to fifth-line DMARDs, by disease severity - page 38
- Figure 23: Percentage of physicians with RA patients who have at least one co-morbidity - page 47
- Figure 24: Prevalence of hypertension in US RA patients, 2004 - page 49
- Figure 25: Treatment algorithm for RA - page 60
- Figure 26: Percentage of physicians using each set of guidelines, by country - page 61
- Figure 27: Number of physicians using different guidelines, by specialty - page 63
- Figure 28: Percentage of patients consulting a rheumatologist directly or via referral, by country - page 64
- Figure 29: Percentage of mild, moderate and severe RA patients referred on to another physician, by specialty - page 65
- Figure 30: Percentage of physicians that refer to each specialist type, split by PCPs and rheumatologists - page 67
- Figure 31: US NSAID/COX-2 quarterly prescriptions (Rx), 2003-2005 - page 70
- Figure 32: Percentage of drug-treated RA patients receiving celecoxib and etoricoxib, by country - page 71
- Figure 33: Trend in prescribing of NSAIDs and COX-2s after the withdrawal of Vioxx - page 72
- Figure 34: Results of Jack Cush's US physician survey, November 2005 - page 75
- Figure 35: Decision tree for physicians treating arthritis patients developing GI complications with NSAIDs - page 76
- Figure 36: Percentage of NSAID-treated patients also receiving a gastro-protective agent, by country and by physician specialty - page 77
- Figure 37: Co-prescription of a PPI with an NSAID, comparing RA to all indications, % RX-Days, 2005 - page 78
- Figure 38: Percentage of RA patients using NSAIDs (including COX-2s), by physician specialty and by disease severity - page 79
- Figure 39: Most commonly used traditional DMARD molecules, by disease severity - page 82
- Figure 40: Number of months a patient will be continued on DMARD therapy before moving to the next line of therapy, by country and by physician specialty - page 84
- Figure 41: Percentage of physicians using DMARD molecules at each line of therapy - page 85
- Figure 42: Percentage of patients on biologics switching or terminating therapy, and key reasons - page 86
- Figure 43: Average influence on prescribing decision: weightings assigned by surveyed physicians to key attributes for biologic and traditional DMARDs - page 89
- Figure 44: Biologic and traditional DMARD attribute weightings assigned by physicians, by country - page 90
- Figure 45: Comparative erosion and JSN scores, by brand - page 93
- Figure 46: Physicians' scores of disease-modification efficacy, by brand - page 93
- Figure 47: Importance of side effects to prescribing of biologic and traditional DMARDs, by country and by physician specialty - page 94
- Figure 48: Physicians' scores of side effects, by brand - page 95
- Figure 49: Comparative ACR 20, 50 and 70 scores for biologic therapies based on their prescribing information - page 98
- Figure 50: Physicians' scores for therapeutic efficacy attributes, by brand - page 99
- Figure 51: Importance of reimbursement/formulary status to prescribing of biologic and traditional DMARDs, by country and by physician specialty - page 100
- Figure 52: Importance of dosing frequency and delivery method to prescribing of biologic and traditional DMARDs, by country and by physician specialty - page 101
- Figure 53: Total biologics brand sales, seven major markets, $m - page 104
- Figure 54: Comparison of total scores for all brands rated, by country and specialist - page 106
- Figure 55: Total score for each brand across the seven major markets - page 107
- Figure 56: Overview brand map of attributes versus brand perception - page 108
- Figure 57: Physician perception of the anti-TNF inhibitors - page 110
- Figure 58: Enbrel map, country preference to prescribing attributes - page 114
- Figure 59: Remicade map, country preference to prescribing attributes - page 117
- Figure 60: Humira attribute scores - page 119
- Figure 61: Kineret attribute scores - page 121
- Figure 62: Orencia attribute scores - page 123
- Figure 63: Rituxan/MabThera attribute scores - page 126
- Figure 64: Patient assessment form, American College of Rheumatology - page 134
- Figure 65: Physician's global assessment - page 135
- Figure 66: Commonly used outcome measures, by specialist - page 136
- Figure 67: Comparison between survey results for expected improvement in disease activity measures after anti-TNF and prescribing information data - page 140
- Figure 68: Average VAS before and after anti-TNF therapy - page 141
- Figure 69: Swollen and tender joint count assessment - page 142
- Figure 70: Compliance estimates by disease severity - page 144
- Figure 71: Reasons why patients do not fill prescriptions or comply with drug regimes, 2002 - page 146
- Figure 72: Importance of challenges facing the RA market - page 147
- Figure 73: IFPMA clinical trials portal - page 150
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