Rheumatoid arthritis (RA) is a chronic inflammatory disorder that affects not only the joints, but also the skin, eyes, lungs, heart and blood vessels. The key to controlling the disease is identifying which patients need to promptly start intensive therapy. However, doing so requires an early diagnosis, which can be difficult as RA’s early symptoms are similar to other diseases. This is compounded by the fact that a prognostic test to refine, or personalise, RA’s current ‘treat to target’ strategy does not exist. As a result, about 43 % of patients are misclassified for treatment intensity. According to researchers with the EU-funded PAPRAT project, the solution is having an early prediction of a patient’s prognosis. “Our aim is to improve current rheumatology clinical practice at the earliest stages of rheumatoid arthritis,” says Lorena Sánchez Martín, director of Making Genetics, a Spanish medical diagnostic/prognostic technology company, and PAPRAT project coordinator.
A highly accurate patient prognosis
At the core of the project is a multi-biomarker that only requires a routine blood sample from the RA clinical lab and some basic clinical data. By combining clinical and demographic factors, the device produces a highly accurate patient prognosis that healthcare providers can use to select the best therapy for managing the disease. “The tool is able to identify those patients with a good prognosis and who will respond to first-line treatments, such as conventional DMARDs,” explains Martín. “More importantly, it quickly identifies those with a poor prognosis and who will benefit from starting high-intensity therapies.” The PAPRAT project oversaw phase 1 of the tool’s development. Work included validating the tool in a relevant environment of 443 patient samples from six different European hospitals and setting up clinical trials. Project researchers also reviewed all regulatory requirements, a process that involved demonstrating the clinical performance, security and quality needed to achieve commercial approval. One challenge the project had to overcome was a change in the governing regulatory framework for in vitro diagnostic medical devices. “Because we had a comprehensive quality system, a thoroughly designed clinical study, and a careful post-market surveillance plan, we were able to quickly adapt to these more restrictive regulations,” adds Martín. The project also helped enhance the tool’s technological components, along with performing a comprehensive market and financial analysis.
A first of its kind
The project succeeded in proving the tool’s technical viability and ensuring it complied with all relevant regulations. As a result, it is now well-positioned for a successful market entry. “PAPRAT is the first prognosis tool specifically designed to classify RA patients attending their requirements of treatment intensity,” concludes Martín. “Most importantly, by giving rheumatologists an early start at effectively treating and managing RA, patients will benefit from an improved quality of life.” Project researchers are currently applying for phase 2 funding, which they will use to further develop the tool’s technology.
PAPRAT, rheumatoid arthritis, rheumatologists, early diagnosis