There is growing concern over the current ‘one-size-fits-all’ approach to drugs used in the treatment of autoimmune (AI) disease, which is in no small part a result of the difficulty associated with identifying AI disease subgroups. This inability to effectively stratify patient populations means that a drug designed to manage specific symptoms can have a range of effects in different patients based on an individual’s genetic predisposition and unique physiological responses. In fact, most drugs used to treat autoimmune diseases show a maximum response rate of only 50 percent1. The result is a large number of patients undergo an often-lengthy trial and error period as clinicians search for the most effective treatment.
To mitigate the imprecise path to the most appropriate treatments, physicians are increasingly looking to companion diagnostics (CDx) that can help to evaluate and define patient subgroups with respect to their unique molecular profile and personalized responses to a particular drug, CDx allow for better patient stratification, and can significantly contribute to improved patient wellbeing, quality of life and long-term prognosis when paired with effective, personalized therapeutics.
CDx Challenges and Benefits
In order to enable the effective development of a companion diagnostic, the drug development program must be aligned with a CDx program from very early in the process. Unlike the development of a cancer drug CDx where the specific targeted genetic mutations are often known from the beginning, development of CDx for autoimmune diseases can be problematic, as no such genetic predispositions or stratification biomarkers are readily available. Thus, due to the lack of appropriate biomarkers drugs are often developed for the full market and the stratification need may not become apparent until relatively late in a clinical development program. Often this information is only brought to light when larger patient groups are being recruited in phase III trials and once their clinical responses or often lack of them are observed.
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