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SP0208 Mri Comes of AGE for Clinical Trials in Rheumatoid Arthritis
  1. C. Peterfy
  1. Spire Sciences, Boca Raton, United States

Abstract

The past two decades have seen unprecedented advances in therapy for rheumatoid arthritis (RA), with several effective biologics introduced since 1998. Radiography played a central role in validating each of these novel agents. However, recent developments have undermined the practicality if not the feasibility of using radiography in clinical trials. Firstly, the availability of effective structure-modifying therapy has made extended placebo control unethical, and thus non-responders are offered rescue therapy or withdrawn by 12-16 weeks. Unfortunately, demonstrating treatment efficacy in less than 24 weeks with radiography is difficult. Another factor reducing radiography's utility has been the recent conversion of most clinical facilities from film-based radiography to digital radiography. While this has been a positive change for image archival, patient throughput and environmental impact, it has added complexity and variability to multicenter clinical trials. This combination of ethical, technical and practical challenges has fueled an urgent need for more sensitive and rapid ways of imaging joint damage and its inflammatory causes in RA. Of the medical imaging alternatives currently available, MRI provides the most viable solution for multi-center trials.

Numerous methodological and observational studies have established the construct validity of MRI depiction of bone erosions and cartilage loss in RA. Not only has MRI been repeatedly shown to be more sensitive than radiography for detecting these classical features of joint damage in RA, MRI is able to visualize the upstream inflammatory drivers of bone erosion and cartilage loss, namely synovitis and osteitis, as well as other important features of the disease, such as tenosynovitis. To date, a total of 10 randomized clinical trials have provided direct evidence of MRI's ability to discriminate progression and treatment effect in RA in less than six months – in some cases even less than three months – using very few patients. In light of this evidence and the ethical imperative to limit the time that patients are exposed to ineffective treatment, it is important that regulatory authorities now consider accepting MRI data as an alternative to radiographic data to support claims of inhibition of progression of structural damage in RA.

Disclosure of Interest C. Peterfy Shareholder of: Spire Sciences, Consultant for: AbbVie, Amgen, Articulinx, AstraZeneca, Bayer, BioClinica, Bristol Myers-Squibb, Celgene, Five Prime, Genentech/Roche, Icon Medical Imaging, Janssen, Lilly, Medimmune, Merck/Schering-Plough, Moximed, Novartis, PAREXEL Informatics, Pfizer, Salix-Santarus, Xoma, Employee of: Spire Sciences, Conflict with: Amgen

DOI 10.1136/annrheumdis-2014-eular.6213

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