Precision Medicine in the Biologic Era: What is Personalized Medicine?

Explore the theme of BIOLOGIC THERAPIES VII SUMMIT, April 6-8, 2017

Precision Medicine in the Biologic Era: What is Personalized Medicine?

By Leonard Calabrese, DO


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The development and availability of an armamentarium of biologic therapeutics over the past two decades has blessed the field of autoimmunity in ways that few could have imagined a generation ago. Single agents can control and achieve deep remission in such seemingly disparate diseases as rheumatoid arthritis, uveitis, inflammatory bowel disease, spondyloarthritis and many others. These agents have given patients a new lease on life and have allowed clinicians who care for autoimmune diseases to literally stop these disorders in their tracks in many patients.

At the same time, our crude disease activity scales – asking patients how they feel, pinching their joints – have stalled the field in many ways; for inflammatory bowel disease, we have even less robust and precise disease activity measures. Similarly, while a remarkable array of therapeutics covers a wide swath of the integrated immune system and targets numerous cytokines, signal transduction pathways and cellular targets, we are still in the dark about how to choose the best agent and how to sequence the rest.

Too much information

Patients are inundated with information on the role of the microbiome, exercise and stress in immune health. They choose their diets, exercise prescriptions, and lifestyle based on competing New York Times’ bestsellers. Many of these patient-oriented publications extol the bounty of “big data” (i.e., the mass of omics including genomics, proteomics, metabolomics, microbiomics and beyond) that can help them achieve their personal health goals. Yet the science is dense and few clinicians are confident they can understand such data in clinically meaningful ways.

In other words, our patients are floundering, trying to decipher the meaning of our exponentially growing database of medical science while their providers – we – are not far ahead.


Earning our successes

For our optimism about the future to manifest, we must adjust our goals (no, we will not live to be 164 years old) and achieve our success the old fashioned way – by earning it.

The President’s Precision Medicine Initiative® Cohort Program is one exciting means toward this end. It will have the scale and scope to enable research for a wide range of diseases, as well as increase our understanding of healthy states. It will assemble a cohort of 1 million people on which to collect and curate all types of data. It is believed a cohort of this size will have the statistical power to detect associations between genetic and/or environmental exposures and a wide variety of health outcomes.

Keeping up with the science

As clinicians, we must challenge ourselves to stay abreast of cutting-edge science in these areas in order to learn from these initiatives. For example:

  • Genetics is no longer viewed solely from a Mendelian perspective, and we need to become more confident in understanding the science of personal genomics and the implications of epigenetics.
  • In immunology, we no longer can interpret homeostasis on the basis of cell populations rigidly defined by single cell surface markers, but as viewed from the complex system of combinatorially defined cell populations that change continuously as we age and defend ourselves from danger.
  • Finally, in cytokine biology, we have demonstrated remarkable successes with our biologic agents targeting TNF administered to over 3 million people worldwide. We now recognize that individuals with autoimmune diseases display their own cytokine fingerprints (referred to as endotypes) that we may be able to harness to more specifically and successfully craft our therapies.

Biologics Summit VII

To address these learning opportunities, we will be holding a summit April 6-8, 2017, at the Intercontinental Hotel and Conference Center in Cleveland, Ohio, designed for all clinicians caring for patients with autoimmune and or autoinflammatory diseases. The summit will highlight the hopes and challenges of precision medicine for the nearly 50 million people in the U.S. with disorders of immunity. Come and explore this rapidly changing field with us. Learn more and register at:


This activity has been approved for AMA PRA Category 1 Credit™.

Dr. Calabrese is Director of the R.J. Fasenmyer Center for Clinical Immunology in Cleveland Clinic’s Department of Rheumatic and Immunologic Diseases.

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