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Autoimmune disease

In 2017, Immunovia announced impressive early results in the diagnostics of – and differentiation between – several different overlapping autoimmune diseases based on the IMMray™ technology platform i.e. Rheumatoid Arthritis, Systemic Lupus Erythematosus (SLE), Sjögren’s Syndrome and Systemic Vasculitis1 . Consequently, the company decided to expand their strategy in the area of autoimmune disorders (press release March 7, 2017 and press release January 12, 2017).

Rheumatoid Arthritis

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 must 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.

Clinical need

Accurate diagnosis remains a major issue as there are no tests that can detect all RA cases. Firstly, 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. Second, 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 an estimated 3-4 million test cases in the US and Europe annually because of the shortcomings of current anti-CCP and anti-RF tests.

Current status

To address this situation Immunovia has completed three discovery studies to assess the potential of IMMray™ 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 vasculitis1 (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 place2 with ongoing implementation in the healthcare systems.

The third 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 encouraged Immunovia to continue with discovery studies in differentiating patients with early RA from the controls having other diseases than RA but exhibiting RA-like symptoms.

Systemic Lupus Erythematosus

Systemic lupus erythematosus (SLE) is a chronic inflammatory rheumatic disease affecting the connective tissues. Patients with SLE can develop a large number of symptoms, ranging from fatigue and rashes to sensitivity to sunlight and relapses of nausea, often in combination. The disease is also characterized by periodic elevations of disease activity, so called SLE flares.

In 2017, Immunovia announced impressive early results in the diagnostics of, and differentiation between, several different overlapping autoimmune diseases based on the IMMray™ technology platform i.e. Rheumatoid arthritis, Systemic Lupus Erythematosus (SLE), Sjögren’s syndrome and Systemic vasculitis1 (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 the major clinical unmet need is monitoring SLE flares and treatment. Preliminary studies published in 20163 showed that the IMMray™ platform could measure SLE high and low activity, but further large discovery studies with many samples per patient would be required to confirm these findings.

References

  1. M Ohlsson et al. Proteomic Data Analysis for Differential Profiling of the Autoimmune Diseases SLE, RA, SS, and ANCA-Associated Vasculitis. J Proteome Res 2021 Feb 5;20(2):1252-1260 Link
  2. Van Steenbergen HW et al. EULAR definition of arthralgia suspicious for progression to rheumatoid arthritis. Ann Rheum Dis 2016;0:1–6
  3. Delfani P. et al. Deciphering systemic lupus erythematosus-associated serum biomarkers reflecting apoptosis and disease activity. Lupus 26(4). September 2016