R&D Trends: Rheumatoid Arthritis - Approaching an era of novel kinase inhibitors

Introduction

Datamonitor has identified a total of 153 products in development for rheumatoid arthritis. There is considerable interest in kinase inhibitors in the rheumatology field and they remain prominent across the pipeline in 2011. Notably, opinion leaders remain hopeful about Pfizer’s tofacitinib (formerly tasocitinib), a Janus kinase (JAK) inhibitor, despite four reported deaths in a Phase III study.

Features and benefits

* Support R&D decision making by evaluating the competitive dynamics of the pipeline.
* Analyze the various rheumatoid arthritis clinical trial designs, with a focus on trial duration, endpoints, and potential future changes.
* Benchmark novel and existing therapies using the ideal target product profile identified by Datamonitor and access leading rheumatologist opinion.

Highlights

Early-stage (preclinical to Phase I) candidates account for 68% of the pipeline. Akin to late-stage projects, kinase and interleukin (IL) inhibitors are prominent. Opinion leaders are keen on IL-6 and -17, JAK and spleen tyrosine kinase inhibitors. Still, it remains to be seen where these early therapies could fit into an already crowded RA market.
Late-stage trials in RA can have numerous designs. However, the design implemented and data collated are important because these directly impact labelling during drug approval. For example, studies over 3- to 6-months support an ‘improvement in signs and symptoms’ label, while 6- to -12-months data aid an ‘inhibition of structural damage’ label.
Inevitably, more trials will be conducted in regions like Eastern Europe and Asia and away from historic markets like the US and Western Europe. Physicians believe that it has become increasingly difficult to recruit large patient numbers from the historic markets who fit into the stringent patient criteria needed to fulfil regulatory requirements.

Your key questions answered

* What are the ideal attributes required for a new therapy to compete with currently marketed treatments?
* Which early stage rheumatoid arthritis targets show promise according to leading rheumatologist opinion?
* Besides kinase inhibition, what are the other emerging therapeutic approaches for rheumatoid arthritis?
* To what extent does clinical trial design impact the eventual drug labelling given to rheumatoid arthritis treatments?
* How has the rheumatoid arthritis pipeline across all stages of development changed since 2010?
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Executive Summary
Strategic scoping and focus
Datamonitor key findings
Related reports
OVERVIEW
Catalyst
Summary
CLINICAL PIPELINE OVERVIEW
Extensive 2011 pipeline demonstrates high commercial interest in rheumatoid arthritis
Analysis by drug class highlights considerable focus on kinase inhibitors
Growing interest in oral small molecules
Late-stage development compounds recently discontinued
dnaJP1 (AT-001; Adeona Pharmaceuticals)
GLPG-0259 (Galapagos)
CEP-37247 (ART621; Cephalon)
RG4934 (Roche)
ILV-095 (PF-05212368; Pfizer)
TARGET PRODUCT PROFILE
Methotrexate is considered the gold standard for rheumatoid arthritis
Enbrel (etanercept; Amgen/Pfizer/Takeda)
Target product profile versus current level of attainment
Efficacy
Safety
Formulation
Cost
CLINICAL TRIAL DESIGN IN RHEUMATOID ARTHRITIS
Proof of concept trials
Clinical trials
[Missing title]
Clinical endpoints
Health Assessment Questionnaire
Other endpoints
Future developments in clinical trial design
Shift towards patient recruitment across multiple countries and away from the US and Western Europe
Physicians desire and anticipate more head-to-head trials against tumor necrosis factor inhibitors
INNOVATIVE EARLY-STAGE APPROACHES
Kinase inhibitors are dominant in the early phase rheumatoid arthritis pipeline
Ranking of key innovative therapeutic approaches in rheumatoid arthritis
Kinase inhibitors, in particular JAK and Syk inhibitors are highly promising therapeutic approaches for RA
Opinion leaders cite interleukin inhibitors as a promising approach for RA
THE FUTURE OF TREATMENT IN RHEUMATOID ARTHRITIS
Oral JAK inhibitor has potential to alter RA treatment landscape
Biomarkers to predict response to biologic therapy
Potential to combine therapies in future treatment of rheumatoid arthritis, but further investigation is needed
BIBLIOGRAPHY
Journal papers
Websites
Datamonitor reports
APPENDIX A
Physician sample breakdown
The survey questionnaire
APPENDIX B
Contributing experts
Conferences attended
Report methodology
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