Rheumatoid Arthritis (RA) is a devastating chronic autoimmune disease that affects nearly 7 million people yearly in US and Europe (Fig. 1), and creates an annual economic burden in the US alone of $19-23 billion, based on direct costs such as hospitalisation, treatment and loss of productivity.
Several other factors contribute to make RA a major healthcare issue that cannot be ignored:
- RA strikes early – the condition most commonly strikes between the ages of 40 and 60.
- RA affects women more than men – women are 3 times more likely to suffer
- RA ends careers – within 10 years of onset over 50% of patients have to leave full-time employment
- RA is not just debilitating – if untreated, RA can shorten life expectancy by 6-10 years
- RA has no single diagnostic test – because symptoms are very similar to other diseases, misdiagnosis is widely prevalent
- Current diagnostic tests are not enough
Furthermore, rheumatoid arthritis symptoms can progress rapidly and with little advance warning, leading to permanent and debilitating joint damage. It is crucial that physicians stay ahead of the disease, since existing treatments can halt or slow down the disease progression.
Accurate diagnosis remains a major issue as there are no tests that can detect all RA cases. To begin with, one of the biggest clinical problems is that over 25% of the patients with advanced RA, unfortunately test negatively for the standard anti-CCP and anti-RF tests, thus making them very difficult to diagnose with current methods. Secondly and even more important, in the early stages of RA, 80% of the patients test negative using the two current standard tests, reinforcing the need for more accurate early diagnostic tools. Overall this leads to estimated 3-4 million test cases in the US and Europe annually because of the shortcomings of current anti-CCP and anti-RF tests.
Solution – IMMray™ blood based biomarker signature for RA
To address this situation Immunovia has completed three discovery studies to assess IMMray™’s potential in autoimmunity testing. These have all recently shown promising results. The first two studies reported excellent accuracy levels using IMMray™ based signatures for the differential diagnosis of overlapping autoimmune rheumatic diseases such as RA, Systemic Lupus Erythematosus (SLE), Sjögren’s Syndrome and Systemic vasculitis (press release March 7, 2017 and press release January 12, 2017). This initial study data has been discussed with numerous Key Opinion Leaders in autoimmune rheumatic diseases. They all expressed great interest in the differential data, but they highlighted the need for more accurate and, most importantly, diagnosis of early RA. In the RA field, healthcare recommendations for early diagnosis are already in place1 and ongoing implementation in the healthcare systems. This strong trend is important for a quick uptake and market penetration of a diagnostic test that would solve the bottlenecks described in the recommendations (Fig. 2 and Fig. 3).
The third recently reported discovery study (press release Aug 22, 2018) showed a major breakthrough: an accuracy higher than 90% for IMMray™ biomarker signatures when diagnosing the CCP negative rheumatoid arthritis patients compared to healthy controls. These exceptionally good results have now triggered Immunovia’s strategic decision to focus on RA.
For the next step towards developing a commercial product, Immunovia has started to engage several Key Opinion Leaders in this field to design and run a study (Fig. 4) aiming to optimize the signature for differentiating the patients with early RA from the controls having other diseases than RA but exhibiting RA-like symptoms.
1. van Steenbergen HW, et al. Ann Rheum Dis 2016;0:1–6