Personalizing The Gut

Personalized and digital healthcare may provide new insights in managing inflammatory bowel disease.

At least once a month, different friends or colleagues approach me to tell me that they or their children have been diagnosed with IBD, a group of diseases that I’ve been working on for the past six years. As I hear their stories—and often their desperation for more effective therapies—what is always clear is the profound impact these diseases have on people and their families. The more of these stories I hear, the more I see how critical it is for us to make progress in better understanding the disease, and in developing safer, more effective treatments for people with IBD. I think we’re getting closer.

Inflammatory bowel disease (IBD), a group of chronic diseases including ulcerative colitis (UC) and Crohn’s disease, is difficult to treat because each disease is complex, and signs, symptoms and underlying mechanisms can vary dramatically from person to person. It’s estimated that about 80% of people with moderate to severe IBD do not experience long-term remission,1 and doctors have no way of knowing how well a treatment will work in any particular patient. But what if we could predict the potential course and severity of UC or Crohn’s disease? We’d finally be able to personalize treatment for each patient—rather than over or undertreating through trial and error approach—and we might be able to deliver better outcomes.

That’s what personalized healthcare is all about, according to Amanda Tatro, group global scientific director, “Our goal is to help people to be on the right therapy at the right time. The ideal situation is knowing when the right moment is to intervene and the right treatment that each person will respond to. It’s about having a personalized care plan and using the tools we have in the most appropriate way for each patient.”

Finding Patterns Of Disease

To date, personalized healthcare has mostly been focused on finding predictive biomarkers for specific therapies, that is, specific molecules or genes that signal an increased or decreased chance of treatment success. The complexities of a condition like IBD require us to go even further by looking at information across a variety of sources.

We collect huge amounts of information in clinical trials—genetic information, tissue and stool samples, colonoscopy images, microbiome data, as well as clinical data—to assess how the disease behaves before and during therapy in people with IBD across a wide range of ages, genders and ethnicities. We also collect patient-reported outcomes and other information from real-world data sources to truly understand how the disease is behaving in diverse groups of people.

All of this information is examined using advanced analytics. Instead of looking at data in silos with the goal of evaluating a single hypothesis, we use every piece of data we acquire to paint a bigger picture. Patient data, across all of these sources, provides new information when aggregated and accumulated to ever-increasing scale, allowing us to answer new questions we couldn't have answered before. By combining and analyzing data from all available sources, we can identify patterns and understand what is driving the disease in specific subgroups of people living with IBD.

What is IBD?

The two main forms of inflammatory bowel disease (IBD) are ulcerative colitis and Crohn’s disease. Both forms are due to improper inflammatory responses in the gastrointestinal tract.2

Gaining The Patient Perspective

Analyzing large amounts of data and developing novel therapies only gets us part of the way there. Communication challenges are consistently flagged as a concern by both people with IBD and their doctors. To truly personalize healthcare, it’s critical to understand a patient’s personal experience and goals.

“We wanted to find a way to help doctors and patients bridge the gap and ensure they are talking about the same things, such as IBD causes or symptoms. For example, what do we mean when we say “flare?” says Tatro. “For physicians, it means a significant inflammatory event. For a patient, it may mean a day they ate things that meant they had to go many times to the bathroom. We needed to find a way to come to a common understanding.”

Differing views on treatment goals in IBD also causes problems. The main goal of IBD management from a doctor’s perspective might be to control the underlying disease in order to help patients in the long-term. But for someone with IBD, aspects of daily life which many of us often take for granted are also very important, such as being able to go to work or school.

This is where patient-reported outcomes (PROs) come in. PROs are health outcomes, such as symptoms of a condition or side effects of a treatment, that are directly reported by the patient who experienced them. PROs are gathered using standardized questionnaires filled out by the patient rather than their doctor or nurse. While PRO tools are being used more widely in pharmaceutical clinical trials, they’re not being utilized widely outside of that setting.

To unlock the potential of digital technology to transform IBD care, we entered a five-year collaboration with Rx.Health, a spin-off from the Mount Sinai Health System in New York, to collaborate on a pioneering digital health initiative for IBD. The first project coming out of this partnership is focused on using real-world evidence through mobile health applications to improve health outcomes in people with IBD in a more personalized way.

Our Approach

We’re looking to comprehensively personalize treatment for people with IBD. This includes not only finding patterns in disease to help us identify who would benefit from specific therapies, or accelerated or more aggressive therapy, from the start, but also looking at indicators such as laboratory data and feedback directly from patients, in an effort to predict key symptoms such as flares, which would help doctors escalate therapy before disease worsens.By applying the patterns we find to each individual, we can better support people throughout the entire journey of their disease.

Sidebar: A Gut Reaction

One exciting area of research has focused on the gut microbiome the vast ecosystem of more than 100 trillion microorganisms that live inside our intestines. Scientists believe the microbiome holds clues to the development and potential treatment of a wide range of diseases, from IBD to multiple sclerosis, diabetes and even autism. The microbiome could play an important role in advancing our understanding of IBD.