Product Profiles: Disease Modification in Rheumatoid Arthritis – Game-changing therapy close to market

Report Summary

The potential for Pfizer’s tofacitinib (CP-690,550) to drive a paradigm change in rheumatoid arthritis treatment edges closer, with news in 2011 that US, EU, and Japanese regulatory agencies are reviewing its applications. 2011 also saw lifecycle management strategies in effect with the launch of a reformulation of Orencia and a strong marketing move to revise the US drug label of Actemra.

Features and benefits

• Access Datamonitor’s independent appraisal of prominent brands and pipeline agents for rheumatoid arthritis.
• Enhance understanding of how marketed and pipeline drugs compare to one another in terms of clinical and commercial attributes.
• Review important clinical developments of novel late-stage pipeline candidates, with analysis of new clinical trial data.
• Gain insight into physician perception and product positioning in the treatment algorithm of key brands.

Highlights

With a novel mode of action, efficacy in line with biologics, and positive data from an active comparator trial versus first-line contender Humira (adalimumab; Abbot/Eisai), tofacitinib displays immense clinical and commercial prospects. Still, its positioning and eventual pricing relative to biologics are unclear and will dictate physician uptake.

Bristol-Myers Squibb executed a key lifecycle management strategy of intravenous brand Orencia with the US launch of a subcutaneous (SC) form in 2011. Enhancing its treatment offering relative to Roche’s Rituxan (rituximab; Biogen Idec) and Actemra (tocilizumab). Still, SC Actemra is in Phase III and new drugs on the horizon pose a future threat.

Roche’s attempt to change market dynamics with Actemra continues. With two ongoing head-to-head trials versus Humira, it has also filed with the FDA to revise Actemra’s label. If granted, it could mean an unprecedented shift in RA treatment, as Actemra, a non-TNF biologic, could be selected ahead of dominant TNF inhibitors Enbrel and Humira.

Your key questions answered

• What are the comparative strengths, weaknesses, opportunities, and threats of the key rheumatoid arthritis products and pipeline candidates?
• To what extent do future therapies satisfy the main clinical unmet needs in rheumatoid arthritis treatment?
• How do rheumatologists perceive key marketed and pipeline agents relative to clinical and commercial attributes?
• What strategies are rheumatoid arthritis market players carrying out in the face of intensifying competition?

Table of Contents

OVERVIEW
Catalyst
Summary

EXECUTIVE SUMMARY
Strategic scoping and focus
Datamonitor key findings
Related reports

PRODUCT OVERVIEW
Key marketed and pipeline products

MARKETED PRODUCT PROFILES
Enbrel (etanercept; Amgen/Pfizer/Takeda)
Drug profile
Development overview
SWOT analysis
Product positioning
Use by line of therapy
Physician perception of Enbrel
Clinical and commercial attractiveness
Humira (adalimumab; Abbott/Eisai)
Drug profile
Development overview
SWOT analysis
Product positioning
Clinical and commercial attractiveness
Remicade (infliximab; Janssen Biotech/Johnson & Johnson/Merck & Co./Mitsubishi Tanabe)
Drug profile
Development overview
SWOT analysis
Product positioning
Clinical and commercial attractiveness
Simponi (golimumab; Janssen Biotech/Johnson & Johnson/Merck & Co./Mitsubishi Tanabe)
Drug profile
Development overview
SWOT analysis
Product positioning
Physician perception of Simponi
Clinical and commercial attractiveness
Cimzia (certolizumab; UCB)
Drug profile
Development overview
SWOT analysis
Product positioning
Physician perception of Cimzia
Clinical and commercial attractiveness
Actemra/RoActemra (tocilizumab; Chugai/Roche)
Drug profile
Development overview
SWOT analysis
Product positioning
Up to 64% of all patients receiving intravenous Actemra would be switched to subcutaneous formulation
Physician perception of Actemra
Clinical and commercial attractiveness
Orencia (abatacept; Bristol-Myers Squibb)
Drug profile
Development overview
SWOT analysis
Product positioning
Physician perception of Orencia
Clinical and commercial attractiveness
Rituxan/MabThera (rituximab; Genentech/Biogen Idec/Roche/Chugai)
Drug profile
Development overview
SWOT analysis
Product positioning
Physician perception of Rituxan/MabThera
Clinical and commercial attractiveness

PIPELINE PRODUCT PROFILES
Tofacitinib (formerly tasocitinib, CP-690,550; Pfizer)
Drug profile
Development overview
SWOT analysis
Satisfaction of unmet needs
Physician perception of tofacitinib
Clinical and commercial attractiveness
FosD (fostamatinib disodium, R788; AstraZeneca/Rigel Pharmaceuticals)
Drug profile
Development overview
SWOT analysis
Satisfaction of unmet needs
Clinical and commercial attractiveness
Other drugs in development for rheumatoid arthritis
AIN457 (secukinumab; Novartis)
Development overview
SWOT analysis
Satisfaction of unmet needs

BIBLIOGRAPHY
Journal papers
Websites
Datamonitor reports

APPENDIX A – SURVEY INFORMATION
Datamonitor's rheumatoid arthritis survey
Physician sample breakdown
Primary research questions

APPENDIX B
Datamonitor drug assessment scorecard
Contributing experts
Conferences attended
Report methodology

List of Tables

Table: Key marketed and pipeline products for rheumatoid arthritis, 2012
Table: Enbrel (etanercept; Amgen/Pfizer/Takeda) drug profile, 2012
Table: Overview of pivotal trial data for Enbrel in rheumatoid arthritis, 2012
Table: Physician-estimated use of each brand at first line of biologic therapy in biologic-eligible rheumatoid arthritis patients, by major market (%), 2010
Table: Mean percentage of rheumatoid arthritis patients receiving Enbrel in the seven major markets, by line of therapy and country (%), 2010
Table: Enbrel (etanercept) scores for each attribute out of 10 in the seven major markets, by country, 2010
Table: Datamonitor drug assessment summary of Enbrel (etanercept) for rheumatoid arthritis, 2012
Table: Humira (adalimumab; Abbott/Eisai) drug profile, 2012
Table: Overview of pivotal trial data for Humira in rheumatoid arthritis, 2012
Table: Humira (adalimumab): head-to-head trials versus Actemra (tocilizumab; Chugai/Roche) and Orencia (abatacept; Bristol-Myers Squibb) in rheumatoid arthritis, 2012
Table: Mean percentage of rheumatoid arthritis patients receiving Humira in the seven major markets, by line of therapy and country (%), 2010
Table: Datamonitor drug assessment summary of Humira (adalimumab) for rheumatoid arthritis, 2012
Table: Remicade (infliximab; Janssen Biotech/Johnson & Johnson/Merck & Co./Mitsubishi Tanabe) drug profile, 2012
Table: Overview of pivotal trial data for Remicade in rheumatoid arthritis, 2012
Table: Mean percentage of rheumatoid arthritis patients receiving Remicade in the seven major markets, by line of therapy and country (%), 2010
Table: : Datamonitor drug assessment summary of Remicade (infliximab) for rheumatoid arthritis, 2012
Table: Simponi (golimumab; Janssen Biotech/Johnson & Johnson/Merck & Co./Mitsubishi Tanabe) drug profile, 2012
Table: Overview of pivotal trial data for Simponi in rheumatoid arthritis, 2012
Table: Ongoing clinical studies of intravenous Simponi in rheumatoid arthritis, 2012
Table: Mean percentage of rheumatoid arthritis patients receiving Simponi in the seven major markets, by line of therapy and country (%), 2010
Table: Simponi (golimumab) scores for each attribute out of 10 in the seven major markets, by country, 2010
Table: Datamonitor drug assessment summary of Simponi (golimumab) for rheumatoid arthritis, 2012
Table: Cimzia (certolizumab; UCB) drug profile, 2012
Table: Overview of pivotal trial data for Cimzia in rheumatoid arthritis, 2012
Table: Mean percentage of rheumatoid arthritis patients receiving Cimzia in the seven major markets, by line of therapy and country (%), 2010
Table: Cimzia (certolizumab) scores for each attribute out of 10 in the seven major markets, by country, 2010
Table: Datamonitor drug assessment summary of Cimzia (certolizumab) for rheumatoid arthritis, 2012
Table: Mean percentage of biologic DMARD patients receiving each TNF brand across the seven major markets, by country and line of therapy (%), 2010
Table: Actemra (tocilizumab; Chugai/Roche) – drug profile, 2012
Table: Overview of pivotal trial data for Actemra in rheumatoid arthritis, 2012
Table: Actemra SC: ACR scores from a Phase I/II open label study
Table: Mean percentage of rheumatoid arthritis patients receiving Actemra in the seven major markets, by line of therapy and country (%), 2010
Table: Actemra (tocilizumab) scores for each attribute out of 10 in the seven major markets, by country, 2010
Table: Datamonitor drug assessment summary of Actemra (tocilizumab) for rheumatoid arthritis, 2012
Table: Actemra: selected ongoing clinical trials in rheumatoid arthritis, 2012
Table: Orencia (abatacept; Bristol-Myers Squibb) drug profile, 2012
Table: Overview of pivotal trial data for Orencia in rheumatoid arthritis, 2012
Table: Mean percentage of rheumatoid arthritis patients receiving Orencia in the seven major markets, by line of therapy and country (%), 2010
Table: Orencia (abatacept) scores for each attribute out of 10 in the seven major markets, by country, 2010
Table: Datamonitor drug assessment summary of Orencia (abatacept) for rheumatoid arthritis, 2012
Table: Rituxan/MabThera (rituximab; Genentech/Biogen Idec/Roche/Chugai) drug profile, 2012
Table: Overview of pivotal trial data for Rituxan in rheumatoid arthritis, 2012
Table: Mean percentage of rheumatoid arthritis patients receiving Rituxan in the seven major markets, by line of therapy and country (%), 2010
Table: Rituxan/MabThera (rituximab) scores for each attribute out of 10 in the seven major markets, by country, 2010
Table: Datamonitor drug assessment summary of Rituxan (rituximab) for rheumatoid arthritis, 2012
Table: Tofacitinib (formerly tasocitinib, CP-690,550; Pfizer) drug profile, 2012
Table: Summary of Phase III trial data and ongoing studies for tofacitinib in rheumatoid arthritis, 2012
Table: Tofacitinib (formerly tasocitinib, CP-690,550) Phase III safety laboratory data in patients with active rheumatoid arthritis who had participated in previous randomized studies of tofacitinib, 2012
Table: Tofacitinib (formerly tasocitinib; CP-690,550) pooled analyses of rates of all-cause mortality and serious infections from its Phase III pivotal studies and long-term extension studies, 2012
Table: Tofacitinib (formerly tasocitinib, CP-690,550; Pfizer) versus comparator drug Enbrel (etanercept; Amgen/Pfizer/Takeda) in rheumatoid arthritis: minimum acceptable product profile and target product profile, 2012
Table: Tofacitinib (formerly tasocitinib, CP-690,550) scores for each attribute out of 10 in the seven major markets, by country, 2010
Table: Datamonitor drug assessment summary of tofacitinib (formerly tasocitinib, CP-690,550) for rheumatoid arthritis, 2012
Table: Percentage of respondents who would prescribe a novel small molecule DMARD in distinct patient groups, 2010
Table: FosD (fostamatinib disodium, R788; AstraZeneca/Rigel Pharmaceuticals) drug profile, 2012
Table: Summary of ongoing Phase III trials for FosD in rheumatoid arthritis, 2012
Table: FosD (fostamatinib disodium, R788; AstraZeneca/Rigel Pharmaceuticals) versus comparator Enbrel (etanercept; Amgen/Pfizer/Takeda) in rheumatoid arthritis: minimum acceptable product profile and target product profile, 2012
Table: Datamonitor drug assessment summary of FosD (fostamatinib disodium, R788) for rheumatoid arthritis, 2012
Table: AIN457 (secukinumab; Novartis) drug profile, 2012
Table: Ongoing Phase II and Phase III trials of AIN457 (secukinumab; Novartis) in rheumatoid arthritis, 2012
Table: AIN457: Phase IIb efficacy data presented at the ACR 2010 annual meeting
Table: AIN457 (secukinumab; Novartis) versus comparator drug Enbrel (etanercept; Amgen/Pfizer/Takeda) in rheumatoid arthritis: minimum acceptable product profile and target product profile, 2012
Table: Rheumatologists surveyed regarding rheumatoid arthritis across the seven major markets, 2010
Table: Datamonitor drug assessment parameters for rheumatoid arthritis, 2012

List of Figures

Figure: Datamonitor drug assessment summary of key marketed and pipeline therapies in rheumatoid arthritis, 2012
Figure: Enbrel SWOT analysis in rheumatoid arthritis, 2012
Figure: Mean percentage of rheumatoid arthritis patients receiving Enbrel in the seven major markets, by line of therapy and country (%), 2010
Figure: Enbrel (etanercept) scores out of 10 for each attribute, average across the seven major markets (n), 2010
Figure: Datamonitor drug assessment summary of Enbrel (etanercept) for rheumatoid arthritis, 2012
Figure: Humira SWOT analysis in rheumatoid arthritis, 2012
Figure: Mean percentage of rheumatoid arthritis patients receiving Humira in the seven major markets, by line of therapy and country (%), 2010
Figure: Datamonitor drug assessment summary of Humira (adalimumab) for rheumatoid arthritis, 2012
Figure: Remicade SWOT analysis in rheumatoid arthritis, 2012
Figure: Mean percentage of rheumatoid arthritis patients receiving Remicade in the seven major markets, by line of therapy and country (%), 2010
Figure: Datamonitor drug assessment summary of Remicade (infliximab) for rheumatoid arthritis, 2012
Figure: Simponi SWOT analysis in rheumatoid arthritis, 2012
Figure: Mean percentage of rheumatoid arthritis patients receiving Simponi in the seven major markets, by line of therapy and country (%), 2010
Figure: Mean percentage of rheumatoid arthritis patients receiving subcutaneous Simponi (golimumab) who would be switched to an intravenous formulation in the seven major markets (%), 2010
Figure: Mean percentage of patients receiving subcutaneous Simponi (golimumab) who would be switched to an intravenous Simponi formulation, by country (%), 2010
Figure: Simponi (golimumab) scores out of 10 for each attribute, average across the seven major markets (n), 2010
Figure: Datamonitor drug assessment summary of Simponi (golimumab) for rheumatoid arthritis, 2012
Figure: Cimzia SWOT analysis in rheumatoid arthritis, 2012
Figure: Mean percentage of rheumatoid arthritis patients receiving Cimzia in the seven major markets, by line of therapy and country (%), 2010
Figure: UCB’s CIMplicity treatment support program for US patients and physicians, 2010
Figure: Cimzia (certolizumab) scores out of 10 for each attribute, average across the seven major markets (n), 2010
Figure: Datamonitor drug assessment summary of Cimzia (certolizumab) for rheumatoid arthritis, 2012
Figure: Subcutaneous Actemra (tocilizumab) Phase III clinical trial design in rheumatoid arthritis, 2012
Figure: Actemra SWOT analysis in rheumatoid arthritis, 2012
Figure: Mean percentage of rheumatoid arthritis patients receiving Actemra in the seven major markets, by line of therapy and country (%), 2010
Figure: Mean percentage of rheumatoid arthritis patients receiving intravenous Actemra (tocilizumab) who would be switched to a subcutaneous Actemra formulation in the seven major markets (%), 2010
Figure: Mean percentage of patients receiving intravenous Actemra (tocilizumab) who would be switched to a subcutaneous Actemra formulation, by country (%), 2010
Figure: Actemra (tocilizumab) scores out of 10 for each attribute, average across the seven major markets (n), 2010
Figure: Datamonitor drug assessment summary of Actemra (tocilizumab) for rheumatoid arthritis, 2012
Figure: Orencia SWOT analysis in rheumatoid arthritis, 2012
Figure: Mean percentage of rheumatoid arthritis patients receiving Orencia in the seven major markets, by line of therapy and country (%), 2010
Figure: Mean percentage of rheumatoid arthritis patients receiving intravenous Orencia (abatacept) who would be switched to a subcutaneous Orencia formulation in the seven major markets (%), 2010
Figure: Mean percentage of patients receiving intravenous Orencia (abatacept) for rheumatoid arthritis who would be switched to a subcutaneous Orencia formulation, by country (%), 2010
Figure: Orencia (abatacept) scores out of 10 for each attribute, average across the seven major markets (n), 2010
Figure: Datamonitor drug assessment summary of Orencia (abatacept) for rheumatoid arthritis, 2012
Figure: Rituxan/MabThera SWOT analysis in rheumatoid arthritis, 2012
Figure: Mean percentage of rheumatoid arthritis patients receiving Rituxan in the seven major markets, by line of therapy and country (%), 2010
Figure: Number of courses on average that a Rituxan/MabThera (rituximab) patient receives per year, 2010
Figure: Rituxan/MabThera (rituximab) scores out of 10 for each attribute, average across the seven major markets (n), 2010
Figure: Datamonitor drug assessment summary of Rituxan (rituximab) for rheumatoid arthritis, 2012
Figure: Tofacitinib SWOT analysis in rheumatoid arthritis, 2012
Figure: Tofacitinib (formerly tasocitinib, CP-690,550) scores out of 10 for each attribute, average across the seven major markets (n), 2010
Figure: Datamonitor drug assessment summary of tofacitinib (formerly tasocitinib, CP-690,550) for rheumatoid arthritis, 2012
Figure: FosD (fostamatinib disodium, R788) TASKi3 Phase IIb clinical trial design and key results in rheumatoid arthritis
Figure: FosD (fostamatinib disodium, R788) time course for the ACR 20 response for R788 and placebo in the TASKi3 trial in rheumatoid arthritis
Figure: FosD (fostamatinib disodium, R788) TASKi2 Phase IIb clinical trial design and summary of results in rheumatoid arthritis
Figure: FosD (fostamatinib disodium, R788) TASKi1 Phase IIa clinical trial design and summary of results in rheumatoid arthritis
Figure: FosD SWOT analysis in rheumatoid arthritis, 2012
Figure: Datamonitor drug assessment summary of FosD (fostamatinib disodium, R788) for rheumatoid arthritis, 2012
Figure: AIN457: Phase IIb efficacy data presented at the ACR 2011 annual meeting
Figure: AIN457 SWOT analysis in rheumatoid arthritis, 2012