APPROACH

Applied public-private research enabling osteoarthritis clinical headway

FACTS & FIGURES

Start Date
End Date
Call
IMI1 - Call 11
Grant agreement number
115770

Contributions
IMI Funding
7 500 000
EFPIA in kind
7 743 323
Other
3 161 425
Total Cost18 404 748

Summary

Some 9.6% of men and 18% of women over 60 suffer from osteoarthritis, and a quarter of those affected struggle to carry out ordinary daily activities. However, developing effective treatments for this debilitating condition is extremely challenging. The APPROACH project is creating a platform comprising data on over 10 000 patients and healthy people. The project team will use this data to identify groups of patients with similar profiles; these groups could respond well to specific treatments. This information will ultimately be used to identify patients who could take part in clinical trials of more personalised treatments for osteoarthritis.

The burden of the disease is increasing yet there is no cure

It is estimated that 9.6% of men and 18% of women over the age of 60 worldwide experience the debilitating symptoms of osteoarthritis. As people tend to live longer, and the population of people over 60 is increasing, cases of the disease are on the rise. Direct and indirect costs of osteoarthritis in the EU are already substantial: in the UK alone, total costs for adaptive aids and devices, medicines, surgery and time off work are estimated to be equivalent to 1% of the gross national product per year. The burden will be greatest in developing countries, where life expectancy is increasing and access to arthroplasty and joint replacement is not readily available. Furthermore, although there are a wide range of devices and palliative medicines available that can relieve pain and improve quality of life, there are currently no pharmaceutical products that can halt or reverse the onset of osteoarthritis.

Despite the large and growing burden of this disease, many pharmaceutical companies have reduced or altogether abandoned drug development. One of the problems is that there are currently no reliable ways of measuring whether a specific treatment is working or not. This is partly because the mechanisms which lead to the disease in different subgroups of patients are poorly understood. Moreover, although the current mind-set for treatment in this field is moving towards personalised medicine, there are no accepted methods of classifying the patients according to diagnosis methodology, prognosis and treatment plan. It is clear that a better understanding of the disease is urgently needed.

Complex algorithms to hunt for disease subtypes

By bringing together a strong team of 25 partners from European clinical centres, basic research institutes, small and medium-sized enterprises (SMEs) and pharmaceutical companies, the APPROACH consortium will combine biomedical data of more than 10 000 patients and heathy people from 8 existing cohorts into a unified bioinformatics platform. With the help of complex algorithms, bioinformaticians will comb through this central database to identify subtypes or phenotypes of osteoarthritis. These subtypes will then be validated in a longitudinal clinical study, using existing and newly-developed biological markers. Ultimately, the identification of subtypes of this disease should lead to improved drug development and diagnostic tools, allowing osteoarthritis patients to receive better, more personalised treatment.

The project will focus on knee osteoarthritis – a very common form of osteoarthritis which is a major cause of impaired mobility (particularly in women) and therefore has a high clinical burden. This form of the disease is ideal for the APPROACH database because it has been extensively examined in large groups of patients and lots of standardised data, such as x-ray and MRI measurements, is available.

Valuable tools and outcomes

At the end of the project, APPROACH will provide valuable tools, methods and definitions that will be used to optimise future clinical trials for osteoarthritis, paving the way for personalised medicine. More specifically, the main outcomes of the project will be as follows:

  • an integrated bioinformatics platform which functions as a repository for clinical data, biomarker data, images, as well as storage of bio-tissues from a broad spectrum of osteoarthritis patients;
  • subsets of patients based on well-defined subtypes or phenotypes of the disease;
  • new biological markers for osteoarthritis based on imaging, locomotion and biochemical methods;
  • validation and optimisation of the next generation imaging methodologies, human motion analysis and biochemical methods to enable more efficient diagnosis and treatment of osteoarthritis patients.

A big step towards more personalised medicine for patients

By identifying different subtypes of osteoarthritis, APPROACH will make a big step forward in helping the pharmaceutical companies develop more effective treatments for the osteoarthritis patients. Patients will reap the greatest benefits as the identification of disease subtypes will lead to improved diagnostic tools and more effective, highly personalised treatments.

Participants Show participants on map

EFPIA companies
  • AbbVie Inc., North Chicago, Illinois, United States
  • Glaxosmithkline Research And Development LTD, Brentford, Middlesex, United Kingdom
  • Institut De Recherches Internationales Servier, Suresnes, France
  • Merck KGaA, Darmstadt, Germany
Universities, research organisations, public bodies, non-profit groups
  • Academisch Ziekenhuis Leiden - Leids Universitair Centrum, Leiden, Netherlands
  • Arthritis Research UK, Chesterfield, United Kingdom
  • Centre National De La Recherche Scientifique, Paris, France
  • Diakonhjemmet Hospital, Oslo, Norway
  • Friedrich-Alexander University (FAU) Erlangen-Nürnberg, Erlangen, Germany
  • Hôpital de la Salpêtrière, Paris , France
  • Lunds Universitet, Lund, Sweden
  • Medizinische Universitaet Wien, Vienna, Austria
  • Servicio Galego de Saúde, Santiago de Compostela, Spain
  • The University of Surrey, Guildford, United Kingdom
  • Universitair Medisch Centrum Utrecht , Utrecht, Netherlands
  • University of Leeds, Leeds, United Kingdom
  • Universitätsklinikum Erlangen, Erlangen, Germany
  • Univesity of Newcastle upon Tyne, Newcastle upon Tyne, United Kingdom
Small and medium-sized enterprises (SMEs)
  • Artialis SA, Liège (Sart-Tilman), Belgium
  • European Technology for Business Ltd, Luton, United Kingdom
  • Hemics B.V., Eindhoven, Netherlands
  • Nordic Bioscience A/S, Herlev, Denmark
  • Stichting Lygature, Utrecht, Netherlands
Patient organisations
  • Stichting Nationaal Reumafonds, Amsterdam, Netherlands
Third parties
  • Université Paris Diderot-Paris 7, Paris, France
Non EFPIA companies
  • Immunodiagnostic Systems Holdings PLC, Boldon, United Kingdom

CONTACT

Project coordinator
Jonathan Larkin
GLAXOSMITHKLINE RESEARCH AND DEVELOPMENT LTD
jonathan.2.larkin[at]gsk.com
Managing entity
Harrie Weinans
University Medical Center Utrecht
h.h.weinans[at]umcutrecht.nl