Pipeline Insight: Disease Modification in Rheumatoid Arthritis - New drug targets compete in crowded market

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Pipeline Insight: Disease Modification in Rheumatoid Arthritis - New
drug targets compete in crowded market
Published on October 2009

Report Summary

Introduction

Drugs with new mechanisms, in particular Pfizer's oral JAK inhibitor CP-690,550 and Chugai/Roche's Actemra (tocilizumab), will
launch for rheumatoid arthritis and should offer advantages over current therapies, but do not come without some safety signals.
Late-stage pipeline launches will be a major contributor to market growth from $7.4 billion in 2008 to $11.5 billion in 2018.

Scope

*In-depth analysis of Phase II and III disease modifying drug candidates in the rheumatoid arthritis pipeline

*Segmentation and analysis of the current rheumatoid arthritis pipeline by developmental phase, drug class and company

*Insight and analysis of market potential including commercial opportunity, epidemiology and discussion of unmet needs

*Focus on innovative early-stage drug development with assessment of future treatment of rheumatoid arthritis

Highlights

The shift from Western regions to countries in Eastern Europe and South America is now a prominent feature of modern rheumatoid
arthritis clinical trials. This has led to variability in placebo and drug responses resulting in higher failure rates. This will continue to be
a difficult hurdle for drug development in rheumatoid arthritis.

Pfizer's JAK inhibitor CP-690,550 blazes the trail for small molecule kinase inhibitors in rheumatoid arthritis. Despite efficacy being in
line with biologics, product positioning, safety and cost are key debatable issues for uptake of this new drug upon launch in 2012.
Datamonitor forecasts sales in the seven major markets of $0.9 billion in 2018.

Pre-launch awareness, robust clinical data and marketing capability leads Datamonitor to believe Actemra (tocilizumab;
Roche/Chugai) will have a significant impact on the market. Safety remains a question, but physicians are willing to deal with issues
highlighted in clinical trials. Datamonitor expects Actemra to achieve blockbuster sales by 2015.

Reasons to Purchase

*Understand the major recent advances in the dynamic and constantly evolving rheumatoid arthritis pipeline

*Evaluate the sales forecasts of key late-stage pipeline products to 2018 and understand new product positioning in this competitive
market

*Assess key opinion leaders' views on the most advanced pipeline products including Pfizer's JAK inhibitor CP-690,550

Pipeline Insight: Disease Modification in Rheumatoid Arthritis - New drug targets compete in crowded market Page 1/15


Table of Content

Overview 1
Catalyst 1
Summary 1
ABOUT DATAMONITOR HEALTHCARE 2
About the Disease pharmaceutical analysis team 2
Executive Summary 3
Strategic scoping and focus 3
Datamonitor insight into the disease market 3
Related reports 4
Upcoming related reports 5
Table of Contents 6
1. Pipeline Overview and Dynamics 7
Key findings 7
Pipeline overview 8
Extensive pipeline highlights commercial interest in rheumatoid arthritis 8
Comparatively few products have made it to Phase III 10
Comparative forecasts - pipeline products generate multi-billion dollar boost to the market 11
Datamonitor pipeline assessment summary - Actemra/RoActemra will be well placed for market success 12
Key companies involved in the rheumatoid arthritis pipeline 13
Roche - Genentech acquisition solidifies its position as a major player in rheumatoid arthritis 13
Pfizer - extensive pipeline with the most advanced kinase inhibitor for rheumatoid arthritis 14
Bristol-Myers Squibb - looking beyond Orencia 15
Key R&D company strategies 16
Focus on oral, small molecule formulations 16
Companies are going for dual subcutaneous and intravenous delivery formulations 17
2. Rheumatoid Arthritis - Market Potential 20
Key findings 20
Definition 21
ICD-10 codes used to define the rheumatoid arthritis market 22
Patient segmentation 23
Early active rheumatoid arthritis 23
Antibody positive rheumatoid arthritis 24
TNF-failure patients 24
Juvenile idiopathic arthritis 25
Classification of juvenile idiopathic arthritis 25
Treatment of juvenile idiopathic arthritis 26
Epidemiology 27
Seven major markets 27
The incidence of rheumatoid arthritis is on the rise in the US 27
Greater incidence of rheumatoid arthritis in females than males 28
Datamonitor estimates there will be 4.4 million rheumatoid arthritis patients in the seven major markets in 2010 29
Datamonitor estimates there are up to 177,000 juvenile idiopathic arthritis patients in the seven major markets 31
Rest of the world 33
Large patient population exists outside of the seven major markets 33



Arthritis in Canada: An Ongoing Challenge, 2003 34
Current treatment options 35
Traditional DMARDs 35
Anti-TNFs 35
B cell therapies 36
T cell co-stimulator modulators 36
Current gold standard and comparator therapies 37
Methotrexate remains the gold-standard for rheumatoid arthritis 37
Comparator therapies 39
Enbrel (etanercept; Amgen, Wyeth [now part of Pfizer]) 39
Current market overview 40
Minimal growth in seven major market rheumatoid arthritis sales between 2007 and 2008 40
Anti-TNF sales were down in 2008, but alternative biologics experienced good uptake in 2007-08 41
Orencia and Rituxan lead year-on-year growth from 2007 to 2008 42
Unmet needs in rheumatoid arthritis 43
Better clinical response 44
30-40% of patients received most effective drugs still don't reach ACR20 44
An add-on therapy for patients doing 'ok' on biologic plus methotrexate 44
Early diagnosis and early treatment 45
Identifying patients who will respond to therapies 46
Establish optimal treatment strategies for TNF-failure patients 47
Oral, small molecules that fill the gap between DMARDs and biologics 47
Understand the impact of combining therapies 48
Treatments and strategies to stop the disease early then stop drug therapy 49
Options for patients who fail all the biologics 49
Current level of attainment vs. target product profile 49
Efficacy 50
Safety 50
Formulation 51
Cost 51
3. R&D Approach 53
Key findings 53
Clinical trial design in rheumatoid arthritis 54
Shift towards patient recruitment from Eastern Europe and South America for clinical trials 54
Trial design 55
Background DMARD trials, add-on or step-up trials are becoming the standard 55
DMARD-naïve trials 56
Head-to-head trials - Bristol-Myers Squibb sets a new precedent 56
Active controlled trials 59
Newer biological agents tested in the anti-TNF-failure patient population 59
Proof of concept trials 59
Methotrexate (MTX) as an active comparator 60
Open label run-in trials avoid use of placebo control, particularly in juvenile idiopathic arthritis 60
Clinical trial endpoint measures 60
American College of Rheumatology 20/50/70 scores 60
Disease Activity Score 61
Modified Disease Activity Score (DAS28) 61
Disease Activity Score using C-reactive protein (CRP) 61
EULAR scores 62
Tender joint count and swollen joint count 62



Radiographic progression 62
Quality of life questionnaires 62
Productivity 63
Other endpoints 63
4. Pipeline Analysis & Forecasts: TNF Inhibitors 64
Key findings 64
Overview for TNF inhibitors 65
Pipeline summary 65
Comparative forecasts 66
Simponi (golimumab; Centocor Ortho Biotech/Schering-Plough/Mitsubishi Tanabe) 67
Drug overview 67
Drug profile 68
Clinical trial data 68
GO-FORWARD 68
GO-BEFORE 69
GO-AFTER 70
Intravenous Simponi - study data presented at EULAR 2009 72
SWOT analysis 75
Datamonitor drug assessment score card for Simponi 76
Clinical and commercial attractiveness 77
Experienced companies add to commercial attractiveness, but arbitration between Johnson & Johnson and Schering-Plough is a
concern 77
Simponi and first-generation anti-TNF Remicade will compete in the same rheumatoid arthritis populations 78
Simponi positioned for use in multiple rheumatoid arthritis patient subgroups but in reality will fall behind established TNF inhibitors 78
Improved dosing frequency will allow competition with other marketed TNF inhibitors 78
Formulation strategy unclear, while intravenous formulation is held up over poor Phase III data 79
Abbott sues Johnson & Johnson over subcutaneous Simponi 79
Satisfaction of unmet needs 79
Forecasts to 2018 80
Cimzia (certolizumab; UCB, Otsuka Pharmaceuticals) 81
Drug overview 82
Drug profile 83
RAPID 1 83
RAPID 2 84
FAST4WARD 85
SWOT analysis 86
Datamonitor drug assessment score card for Cimzia 87
Cimzia is not sufficiently differentiated from the other anti-TNFs 88
UCB has launched a prefilled syringe, but other anti-TNFs have easy-to-inject pen formulations 89
Other drugs in TNF inhibitor class 92
ART621 (Domantis [GlaxoSmithKline]/Arana Therapeutics) 92
Drug overview 92
TNF alpha kinoid (Neovacs) 94
Drug overview 94
Late-stage development compounds recently discontinued 95
SSR150106 95



Key early-stage and preclinical compounds in TNF inhibitors 96
5. Pipeline Analysis & Forecasts: B Cell Targets 97
Key findings 97
Overview for B Cell targets 98
Pipeline summary 98
Ocrelizumab (Genentech, Biogen Idec, Roche and Chugai) 100
Drug overview 100
Drug profile 101
Phase II ACTION study 101
Phase III studies: STAGE, SCRIPT, FILM and FEATURE 102
Japanese Phase III studies 103
SWOT analysis 105
Datamonitor drug assessment score card for ocrelizumab 106
Genentech and Roche are experienced players in the rheumatoid arthritis market 107
Minimal Phase II clinical data, but demonstrated similar efficacy and safety to Rituxan/MabThera 108
Active comparison with Remicade in single TNF failure patients 108
Downside is that ocrelizumab is not really differentiated from Rituxan/MabThera 108
Arzerra (ofatumumab; Genmab, GlaxoSmithKline) 112
Drug overview 112
Drug profile 113
Clinical trial data - Phase III 113
Top-line trial data in methotrexate-failure patients 113
Phase III trial program summary 114
Clinical trial data - Phase II 114
SWOT analysis 116
Datamonitor drug assessment score card for Arzerra 116
Positive Phase III data emerging, but data in TNF-failures keenly awaited 117
Not adequately differentiated from other B cell therapies Rituxan/MabThera or ocrelizumab 117
Subcutaneous formulation is an advantage, but is 5 years away from market 118
Other drugs in B Cell targets class 121
Atacicept (TACI-Ig; ZymoGenetics, Merck Serono) 121
Benlysta (belimumab; Human Genome Sciences, GlaxoSmithKline) 122
Drug overview 122
TRU-015 (Trubion Pharmaceuticals, Wyeth/Pfizer) 124
Drug overview 124
LY2127399 127
Drug overview 127
Veltuzumab (IMMU106; Immunomedics) 130
B cell targets recently discontinued 130



Briobacept (BR3-Fc; Biogen Idec, Genentech) 130
Key early-stage and preclinical compounds in B cell targets class 131
6. Pipeline Analysis & Forecasts: Other Cytokine antagonists 132
Key findings 132
Overview for other cytokine antagonists 133
Pipeline summary 133
Actemra/RoActemra (tocilizumab; Chugai, Roche) 133
Drug overview 134
Drug profile 135
OPTION 135
TOWARD 136
RADIATE 137
AMBITION 138
LITHE 139
SWOT analysis 140
Datamonitor drug assessment score card for Actemra 141
Large Phase III program and excellent clinical efficacy enable Actemra to compete with Rituxan and Orencia, but also at first-line 142
As a major player in the rheumatoid arthritis market, Roche adds considerable commercial weight to Actemra 143
Currently similar dosing to Orencia, but the future may also bring subcutaneous delivery 144
Safety signals may dampen uptake initially; REMS in place in the US 144
Deaths related to Actemra intensify the long-term safety worries 145
Other drugs in cytokine antagonists 149
Canakinumab (Ilaris, ACZ885; Novartis) 149
Drug overview 149
Clinical trial data - rheumatoid arthritis 150
Clinical trial data - systemic juvenile idiopathic arthritis 151
Iguratimod (T-164, Careram; Toyama Chemical; Eisai) 152
Drug overview 152
Denosumab (AMG162; Amgen) 152
Drug overview 152
AMG108 (Amgen) 154
Drug overview 154
CNTO136 (Centocor Ortho Biotech) 155
Drug overview 155
Anti IL-17 antibody (LY2439821; Eli Lilly) 156
Drug overview 156
K832 (Kowa Pharmaceuticals) 157
Drug overview 157
AIN457 (Novartis) 158
Drug overview 158
Apilimod (STA5326; Synta Pharmaceuticals) 159



XOMA052 (Xoma) 160
ALD-518 (Alder Biopharmaceuticals) 160
Givinostat (ITF2357; Italfarmaco) 160
AZD5672 161
MLN-3897 161
LY2189102 161
Key early-stage and preclinical compounds in cytokine antagonist class 162
7. Pipeline Analysis & Forecasts: Kinase Inhibitors 163
Key findings 163
Overview for kinase inhibitors 164
CP-690,550 (Pfizer) 166
Drug overview 166
Drug profile 167
Clinical trial design - Phase III 167
Clinical trial design and data - Phase II 169
Ongoing Phase II trials 169
Completed Phase II trial summary 169
A3921039 trial data 170
A3921035 trial data 171
CP-690,550 effects on pain, physical function and HRQoL - A3921035 and A3921025 trial data 172
SWOT analysis 173
Datamonitor drug assessment score card for CP-690,550 174
Large Phase III trial program will provide evidence of efficacy across every rheumatoid arthritis population 175
Phase II data support efficacy and rapid action of CP-690,550 177
Safety profile highlights some issues, but overall manageable 177
Cost of CP-690,550 remains a major factor for consideration 178
R788 (Fostamatinib disodium; Rigel Pharmaceuticals) 182
Drug overview 183
Drug profile 183
Clinical trial data - Phase II trial data mixed, but Datamonitor is positive 183
TASKi3 183
TASKi2 186
TASKi1 188
SWOT analysis 189
Datamonitor drug assessment score card for R788 189
Datamonitor expects R788 will be positioned in DMARD or methotrexate failures 190
Datamonitor sees benefit with oral drug, but some safety signals exist with R788 190
Essential that Rigel finds partner quickly for R788 191
Other drugs in the kinase inhibitors class 195
Masitinib (AB1010; AB Science) 195
ARRY162 (ARRY-438162; Array BioPharma) 197



BMS-582949 (Pharmacopeia, Bristol-Myers Squibb) 199
GW856553 (GlaxoSmithKline) 201
INCB18424 (Incyte) 202
INCB28050 (Incyte) 203
PH797804 204
P38 MAP kinase inhibitors showing high attrition rate in rheumatoid arthritis 206
VX702 (Vertex Pharmaceuticals) 206
Talmapimod (SCIO469; Scios Inc/Johnson & Johnson) 207
ARRY797 (ARRY-371797; Array BioPharma) 208
8. Pipeline Analysis & Forecasts: Others 209
Key findings 209
Overview for Others 210
dnaJp1 (Adeona Pharmaceuticals) 210
T-5224 (Toyama Chemical) 212
4SC-101 (SC-12267; 4SC) 212
BT061 (Biotest) 213
CH1504 (Chelsea Therapeutics) 213
Tranilast (Nuon Therapeutics) 214
MDX-1100 (Medarex (Bristol-Myers Squibb) 215
MM093 (GTC Biotherapeutics/Merrimack Pharmaceuticals) 215
Rabeximod (Rob803; OxyPharma) 216
PG760564 (Proctor & Gamble) 216
RWJ-445380 (ALZA Corp, Johnson & Johnson) 216
LX-2931 (LX-3305; Lexicon Pharmaceuticals) 217
Fezakinumab (ILV-094; Wyeth [now Pfizer]) 218
PI2301 (Peptimmune) 218
Recent high-profile discontinuations highlight P2X7 antagonism may not be successful target 218
AZD9056 (AstraZeneca) 219
CE-224535 (Pfizer) 219
TAK783 (Takeda) 219
Key early-stage and preclinical compounds in Others class 220
9. Innovative Early-Stage Approaches 221
Key findings 221
Overview of early-stage innovative projects 222
Kinase inhibitors represent a large proportion of the drugs in early phase development 222
The anti-GM-CSF strategy: the next promising target' 223
Drug targeting GM-CSF could be the next blockbuster cytokine class 223
Several GM-CSF-directed therapies looking to advance into Phase II for rheumatoid arthritis 224
NFKappaB 225
Chemokine receptor antagonists 226
The future of treatment in rheumatoid arthritis 227
Combining therapies will be commonplace in future treatment of rheumatoid arthritis 227
Biomarkers to predict response to biologic therapy 228
Bibliography 229
Journals 229
Websites 239
Datamonitor reports 250



Other sources 250
APPENDIX 251
Methodology 251
Datamonitor forecast methodology 251
Product forecasts 251
Exchange rates 251
Definition of a standard unit 251
Japan methodology 251
Datamonitor drug assessment scorecard methodology 252
Contributing experts 252
About Datamonitor 254
About Datamonitor Healthcare 254
About the Disease analysis team 254
Datamonitor consulting 255
Disclaimer 256
List of Tables
Table 1: Late-phase pipeline products in development for rheumatoid arthritis, 2009 9
Table 2: Sales forecasts for pipeline products in late-stage development in rheumatoid arthritis in the seven major markets ($m),
2009-2018 12
Table 3: Roche's rheumatoid arthritis marketed and pipeline product portfolio, 2009 14
Table 4: Pfizer's rheumatoid arthritis pipeline portfolio, 2009 15
Table 5: Bristol-Myers Squibb's rheumatoid arthritis pipeline portfolio, 2009 16
Table 6: Pipeline products with both subcutaneous and intravenous formulations in potential development for rheumatoid arthritis,
2009 19
Table 7: Datamonitor's definition of rheumatoid arthritis 22
Table 8: Efficacy of common medication used to treat juvenile idiopathic arthritis, 2009 26
Table 9: Marketed and pipeline products for juvenile idiopathic arthritis, 2009 27
Table 10: Incidence rates (cases/1,000) of rheumatoid arthritis worldwide in studies based on ACR criteria, 1993-2002 29
Table 11: Prevalence of rheumatoid arthritis across the seven major markets, 2010 30
Table 12: Estimated total rheumatoid arthritis (RA) populations in each of the seven major markets, 2010-2020 31
Table 13: Epidemiology studies into juvenile idiopathic arthritis (JIA), 1987-2007 32
Table 14: Estimated juvenile idiopathic arthritis (JIA) prevalence and population across the seven major markets, 2010 33
Table 15: Estimated juvenile idiopathic arthritis (JIA) population in the seven major markets, 2010-2020 33
Table 16: Datamonitor's estimated prevalence figures for rheumatoid arthritis in regions outside the seven major markets, 2009 34
Table 17: Leading treatments for rheumatoid arthritis, 2009 37
Table 18: Enbrel (etanercept) - Drug profile, 2009 40
Table 19: Ability of current comparator Enbrel to meet unmet needs in rheumatoid arthritis, 2009 52
Table 20: ACR scores in biologic-naïve versus TNF-failure rheumatoid arthritis patients 59
Table 21: Key products in the late-stage R&D pipeline for TNF inhibitors for rheumatoid arthritis, 2009 65
Table 22: Sales forecasts for new TNF inhibitors in rheumatoid arthritis in the seven major markets ($m), 2008-2018 67
Table 23: Simponi - Drug profile, 2009 68
Table 24: Simponi (golimumab): Efficacy results in patients previously receiving anti-TNFs for rheumatoid arthritis, 2009 72
Table 25: Simponi (golimumab): efficacy data for intravenous Simponi (golimumab) at week 14, week 24 and week 48 in rheumatoid
arthritis, 2009 74
Table 26: Simponi versus TNF inhibitor comparator therapy Enbrel in rheumatoid arthritis - minimum acceptable product profile
(MAPP) and target product profile (TPP), 2009 80
Table 27: Simponi (golimumab): sales forecasts in the seven major markets ($m), 2009-2018 81
Table 28: Cimzia - Drug profile, 2009 83
Table 29: Cimzia versus TNF inhibitor comparator therapy Enbrel in rheumatoid arthritis - minimum acceptable product profile and
target product profile, 2009 90



Table 30: Cimzia (certolizumab): sales forecasts for in the seven major markets ($m), 2009-2018 92
Table 31: Neovacs's kinoid active antibody therapy: advantages compared to standard monoclonal antibody therapy 95
Table 32: Key products in the early-stage R&D pipeline for TNF inhibitors, 2009 96
Table 33: Key products in the late-stage R&D pipeline for B Cell targets for rheumatoid arthritis, 2009 98
Table 34: Sales forecasts for B cell therapies in the seven major markets ($m), 2009-2018 100
Table 35: Ocrelizumab - Drug profile, 2009 101
Table 36: Ocrelizumab: Phase III clinical trial program in rheumatoid arthritis, 2009 103
Table 37: Ocrelizumab versus comparator therapy Enbrel in rheumatoid arthritis -minimum acceptable product profile and target
product profile, 2009 110
Table 38: Ocrelizumab: sales forecasts in the seven major markets ($m), 2009-2018 112
Table 39: Arzerra - Drug profile, 2009 113
Table 40: Arzerra (ofatumumab): ongoing Phase III and Phase I/IIa trials in rheumatoid arthritis, 2009 114
Table 41: Arzerra (ofatumumab): week 48 follow-up data for Phase II trial in DMARD-failure rheumatoid arthritis patients, 2008 115
Table 42: Arzerra (ofatumumab) versus comparator therapy Enbrel in rheumatoid arthritis - minimum acceptable product profile and
Table 43: Arzerra (ofatumumab): sales forecasts in the seven major markets ($m), 2009-2018 121
Table 44: Atacicept (TACI-Ig); summary of Phase II clinical trials in rheumatoid arthritis, 2009 122
Table 45: Key early-stage compounds targeting B cells in rheumatoid arthritis in 2009. 131
Table 46: Key products in the late-stage R&D pipeline for cytokine antagonists for rheumatoid arthritis, 2009 133
Table 47: Actemra/RoActemra - Drug profile, 2009 135
Table 48: Actemra (tocilizumab) versus cytokine antagonist comparator therapy Enbrel - minimum acceptable product profile and
Table 49: Actemra/RoActemra (tocilizumab): sales forecasts in the seven major markets ($m), 2008-2018 149
Table 50: Denosumab (AMG162): MRI erosion score at 6 months and clinical efficacy scores at 12 months from the Phase II study in
rheumatoid arthritis, 2008 154
Table 51: AIN457: proof-of-concept study results in rheumatoid arthritis, 2009 159
Table 52: Key early-stage and preclinical compounds in the cytokine antagonist class in development for rheumatoid arthritis, 2009
162
Table 53: Key products in the late-stage R&D kinase inhibitor pipeline for rheumatoid arthritis., 2009 164
Table 54: Sales forecasts for kinase inhibitors in the seven major markets ($m), 2009-2018 166
Table 55: CP-690,550 - Drug profile, 2009 167
Table 56: CP-690,550: Summary of ongoing, recruiting Phase III rheumatoid arthritis trials, 2009 168
Table 57: CP-690,550: summary of ongoing, recruiting Phase II rheumatoid arthritis trials , 2009 169
Table 58: CP-690,550: Phase II clinical trial information for completed studies, 2009 170
Table 59: CP-690,550: A3921035 and A3921025 trial data, 2009 173
Table 60: CP-690,550 versus TNF inhibitor comparator therapy Enbrel in rheumatoid arthritis - minimum acceptable product profile
and target product profile, 2009 180
Table 61: CP-690,550: sales forecasts in the seven major markets ($m), 2009-2018 182
Table 62: R788 - Drug profile, 2009 183
Table 63: R788 versus comparator therapy Enbrel in rheumatoid arthritis, minimum acceptable product profile and target product
profile, 2009 193
Table 64: R788: sales forecasts in the seven major markets ($m), 2009-2018 195
Table 65: Masitinib (AB1010): Summary of efficacy outcomes at week 12 with subgroup analysis according to previous treatment
failure, 2009 197
Table 66: ARRY162: clinical trial efficacy results(ARRAY-162-201) - ACR20 scores at week 12 across geographic regions, 2009 198
Table 67: ARRY162: clinical trial safety results ARRAY-162-201) - most common adverse events, 2009 199
Table 68: GW856553: Completed Phase II trials in rheumatoid arthritis, 2008 202
Table 69: SCIO469's Phase II trial results in rheumatoid arthritis, 2008 208
Table 70: Key products in the late-stage R&D pipeline for Others for rheumatoid arthritis, 2009 210
Table 71: 4SC-101: Phase IIa clinical trial data in rheumatoid arthritis patients who previously failed treatment with DMARDs, 2007



213
Table 72: Key early-stage products in the R&D pipeline for Others, 2009 220
Table 73: Early-stage candidates targeting granulocyte-macrophage colony stimulating factor in development for rheumatoid arthritis,
2009 225
Table 74: NF-kappaB inhibitors in early-stage development for rheumatoid arthritis, 2009 226
Table 75: Chemokine receptor antagonists in early-stage development for rheumatoid arthritis, 2009 227
Table 76: Datamonitor drug assessment parameters 252
List of Figures
Figure 1: Rheumatoid arthritis pipeline split by highest development phase and drug class, 2009 11
Figure 2: Datamonitor's pipeline assessment summary for rheumatoid arthritis, 2009 13
Figure 3: Rheumatoid arthritis pipeline split by formulation, and type of molecule for oral products, 2009 17
Figure 4: Datamonitor's strategy for switching between intravenous and subcutaneous formulations in rheumatoid arthritis, 2009 18
Figure 5: Datamonitor's methodology for calculating rheumatoid arthritis specific sales from IMS total brand sales and volume data 23
Figure 6: Datamonitor's estimated number of rheumatoid arthritis patients receiving biologic therapy as anti-TNFs or alternative
mechanisms in the seven major markets, 2007-2017 25
Figure 7: Classification of juvenile idiopathic arthritis (JIA), 2009 26
Figure 8: Age-adjusted incidence of rheumatoid arthritis in Rochester, Minnesota, 1955-2005 28
Figure 9: Top 5 Rest of World countries with highest prevalent populations of rheumatoid arthritis, 2009-2019 35
Figure 10: Rheumatoid arthritis-specific sales in the seven major markets, split by region ($ billion), 2004-08 41
Figure 11: Rheumatoid arthritis-specific sales in the seven major markets, split by drug class ($ billion), 2004-08 42
Figure 12: Performance of the top 10 brands/molecules and All Others in the seven major rheumatoid arthritis markets, 2004-08 43
Figure 13: Key unmet needs in rheumatoid arthritis, 2009 44
Figure 14: Orencia versus Humira head-to-head clinical trial design in rheumatoid arthritis (RA), 2009 58
Figure 15: EULAR response criteria as defined by DAS28 62
Figure 16: Datamonitor drug assessment summary for tumor necrosis factor (TNF) inhibitors in development for rheumatoid arthritis,
2009 66
Figure 17: Simponi (golimumab): GO-FORWARD: Clinical trial design and results at week 14 in rheumatoid arthritis (RA), 2008 69
Figure 18: Simponi (golimumab): GO-BEFORE: Clinical trial design and results at week 24 in rheumatoid arthritis (RA), 2008 70
Figure 19: Simponi (golimumab): GO-AFTER: Clinical trial design and results at week 14 in rheumatoid arthritis, 2008 71
Figure 20: Simponi (golimumab): Phase III study design for intravenous dose in rheumatoid arthritis, 2009 73
Figure 21: Simponi SWOT analysis, 2009 76
Figure 22: Datamonitor's competitive positioning analysis of Simponi (golimumab), 2009 77
Figure 23: Cimzia (certolizumab): UCB's RAPID 1 trial in rheumatoid arthritis patients who failed methotrexate therapy, 2008 84
Figure 24: Cimzia (certolizumab): UCB's RAPID 2 trial in rheumatoid arthritis patients who failed methotrexate therapy, 2009 85
Figure 25: Cimzia (certolizumab): UCB's FAST4WARD trial as a monotherapy in rheumatoid arthritis patients who failed DMARD
therapy, 2009 86
Figure 26: Cimzia SWOT analysis, 2009 87
Figure 27: Datamonitor's competitive positioning analysis of Cimzia (certolizumab), 2009 88
Figure 28: ART621: Phase II clinical trial design in rheumatoid arthritis dose optimization study, 2009 93
Figure 29: ART621: Phase II clinical trial design in rheumatoid arthritis dose ranging study, 2009 94
Figure 30: Datamonitor drug assessment summary for B cell targets in development for rheumatoid arthritis, 2009 99
Figure 31: Ocrelizumab: efficacy data from Phase II ACTION trial in rheumatoid arthritis, 2007 102
Figure 32: Ocrelizumab: Phase III trial in Japanese rheumatoid arthritis patients who have failed therapy with anti-TNFs, 2009 104
Figure 33: Ocrelizumab: Phase II trial in Japanese rheumatoid arthritis patients, 2009 105
Figure 34: Ocrelizumab: SWOT analysis, 2009 106
Figure 35: Datamonitor's competitive positioning analysis of ocrelizumab, 2009 107
Figure 36: Arzerra (ofatumumab): week 24 ACR scores in DMARD-failure rheumatoid arthritis patients, 2007 115
Figure 37: Arzerra (ofatumumab): SWOT analysis, 2009 116
Figure 38: Datamonitor's competitive positioning analysis of Arzerra (ofatumumab), 2009 117
Figure 39: Benlysta (belimumab): LBRA01 Phase II clinical trial design and summary of results for rheumatoid arthritis, 2005 124



Figure 40: TRU-015: Phase IIb Study Two clinical trial design for rheumatoid arthritis, 2009 125
Figure 41: TRU-015: Phase IIb Study One clinical trial design summary and trial results for rheumatoid arthritis 126
Figure 42: TRU-015: Phase IIb Study One - open label retreatment data with 800mg TRU-015 for rheumatoid arthritis 127
Figure 43: LY2127399 (IV): trial design and results of first Phase II study (H9B-MC-BCDF) in rheumatoid arthritis, 2008 128
Figure 44: LY2127399 (IV): trial design of Phase II study (H9B-MC-BCDG) in TNF-failure rheumatoid arthritis patients, 2009 129
Figure 45: LY2127399 (SC): trial design of Phase II study (H9B-MC-BCDH) in patients with rheumatoid arthritis despite ongoing
methotrexate, 2009 130
Figure 46: Actemra (tocilizumab): OPTION study design and results in rheumatoid arthritis, 2008 136
Figure 47: Actemra (tocilizumab): TOWARD study design and results in rheumatoid arthritis, 2008 137
Figure 48: Actemra (tocilizumab): RADIATE study design and results in rheumatoid arthritis, 2008 138
Figure 49: Actemra (tocilizumab): AMBITION study design and results in rheumatoid arthritis, 2009 139
Figure 50: Actemra (tocilizumab): LITHE study design and results in rheumatoid arthritis, 2008 140
Figure 51: Actemra/RoActemra SWOT analysis, 2009 141
Figure 52: Datamonitor's competitive positioning analysis of Actemra (tocilizumab), 2009 142
Figure 53: Canakinumab (ACZ885): Phase I/II clinical trial design and trial data for in rheumatoid arthritis, 2008 150
Figure 54: Denosumab (AMG162): Phase II trial design for rheumatoid arthritis, 2008 153
Figure 55: AMG108: Phase II clinical trial design and efficacy data in rheumatoid arthritis patients, 2009 155
Figure 56: LY2439821: Phase II clinical trial design and efficacy data in rheumatoid arthritis, 2009 157
Figure 57: ALD518: Clinical trial design of Phase II study in rheumatoid arthritis, 2009 160
Figure 58: AZD5672: clinical trial design of Phase IIb proof-of-concept study of in rheumatoid arthritis, 2009 161
Figure 59: Datamonitor drug assessment summary for kinase inhibitors in development for rheumatoid arthritis, 2009 165
Figure 60: CP-690,550: Phase II (A3921039) trial of four doses, in combination with methotrexate, in Japanese rheumatoid arthritis
patients with an inadequate response to methotrexate, 2009 171
Figure 61: CP-690,550: 12-week interim data from Phase II (A3921035) trial in rheumatoid arthritis patients with an inadequate
response to DMARDs, 2009 172
Figure 62: CP-690,550:: SWOT analysis, 2009 174
Figure 63: Datamonitor's competitive positioning analysis of CP-690,550, 2009 175
Figure 64: R788: TASKi3 Phase IIb clinical trial design and key results in rheumatoid arthritis, 2009 185
Figure 65: R788: Time course for the ACR20 response for R788 and placebo in the TASKi3 trial in rheumatoid arthritis, 2009 186
Figure 66: R788: TASKi2 Phase IIb clinical trial design and summary of results in rheumatoid arthritis, 2009 187
Figure 67: R788: TASKi1 Phase IIa clinical trial design and summary of results in rheumatoid arthritis, 2008 188
Figure 68: R788 SWOT analysis, 2009 189
Figure 69: Datamonitor's competitive positioning analysis of R788, 2009 190
Figure 70: Masitinib (AB1010): Design of the ongoing Phase II (AB06010) trial in rheumatoid arthritis, 2009 196
Figure 71: Masitinib (AB1010): Design of the completed Phase IIa (AB04012) trial in rheumatoid arthritis, 2006 196
Figure 72: ARRY162: Phase II clinical trial (ARRAY-162-201) design in rheumatoid arthritis, 2009 198
Figure 73: BMS-582949: Phase II clinical trial design in rheumatoid arthritis, 2009 200
Figure 74: BMS-582949: Phase I trial design and results highlights, 2008 201
Figure 75: INCB18424: Phase IIa clinical trial design in rheumatoid arthritis, 2008 203
Figure 76: INCB28050: Phase II clinical trial design in rheumatoid arthritis, 2009 204
Figure 77: PH797804: Phase II trial as a monotherapy in rheumatoid arthritis patients who failed DMARDs, 2008 205
Figure 78: PH797804: Phase II trial (A6631005) as a combination therapy with methotrexate in rheumatoid arthritis, 2008 206
Figure 79: VX702: Clinical trial design summary for Phase II trials in rheumatoid arthritis, 2009 207
Figure 80: dnaJp1: Phase II clinical trial design for in rheumatoid arthritis, 2007 212
Figure 81: CH1504: Phase II trial design showing efficacy and safety results in rheumatoid arthritis, 2009 214
Figure 82: Tranilast: Nuon Therapeutics' Phase II trial in combination with methotrexate in rheumatoid arthritis, 2009 215
Figure 83: MM093: Phase II clinical trial design in rheumatoid arthritis, 2008 216
Figure 84: RWJ-445380: Phase IIa clinical trial in active rheumatoid arthritis patients despite methotrexate, 2008 217
Figure 85: LX-2931 (LX-3305): Phase II trial in rheumatoid arthritis, 2009 218
Figure 86: TAK783: Phase II clinical trial design in rheumatoid arthritis, 2009 220



Figure 87: Early-stage projects, split by drug class, in development for rheumatoid arthritis, 2009 222
Figure 88: Early phase kinase inhibitors in development for rheumatoid arthritis split by target, 2009 223
Figure 89: Role of macrophages in model of rheumatoid arthritis pathogenesis 224



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