Autoimmune diseases and the power of separation
As scientific progression continues its march forward, the word ‘separation’ is something that we rarely hear. Instead, the trend is towards integration: integrated methodologies, integrated systems, integrated research. However, when it comes to diagnostics (Dx) and disease treatment, there is power in separation and stratification. In the challenging area of autoimmune disease Dx, patients frequently present with a complex mix of disease non-specific symptoms that can rise and fall in both severity and location. This makes an accurate and timely diagnosis a difficult task for even the most experienced medical professional.
The inability to separate patients with different autoimmune diseases has a huge negative impact on any subsequent treatment. In fact, the current selection of drugs available to treat autoimmune disease are effective in only around 50% of cases. It’s abundantly clear the old ‘one-size-fits-all’ approach is woefully inefficient when it comes to treating autoimmune diseases. Instead, we are in dire need of a more personalized approach to treating these diseases.
Separating individuals from the mix
In order to treat patients effectively, their disease first needs to be understood, separated from similar yet non-related diseases, and then targeted with a personalized therapy. This approach is facilitated by the development of powerful biomarkers capable of stratifying patient subgroups and aiding in treatment response prediction. Biomarkers are already used in the context for other diseases in the form of companion diagnostics (CDx): the breast cancer drug Herceptin® for example, is used only in conjunction with its CDx, HER-2/neu, identifying those with greatly improved chances of benefiting from Herceptin.
The power of CDx is clear, but their uptake has been slow with just twenty FDA-approved tests. This will all begin to change as we improve our approach to using biomarkers in more complex combinations, bringing together different markers, such as single nucleotide polymorphisms (SNPs), cytokines and autoantibodies, into a single multimarker panel. Despite the time and financial investment underpinning multimarker panels, they have enormous potential to lay the foundations of CDx. In this case, the integration of different markers will aid in the separation and stratification of patients suffering with autoimmune diseases.
A spectrum of benefits
CDx offer benefits, first and foremost, to the patient. If a doctor, able to employ multimarker Dx used in the development of CDx, can accurately differentiate between autoimmune diseases, then the most effective course of treatment can be administered right away. But the benefits extend beyond a diagnosis. Patient selection for clinical trials of novel treatments could be based on biomarker data and response prediction, making endpoints more likely to be achieved. This has a knock on effect for the time required to achieve regulatory approval; we’ve already seen this with Zelboraf® and Xalkori® – both approved with their respective CDx – reaching markets in under five years after clinical trials. CDx benefits all stakeholders involved, and although it may take time and education for industry and healthcare systems to realize, CDx will promote cheaper, more effective patient healthcare for those with autoimmune diseases.
by Georg Lautscham, Protagen Diagnostcs