IBD rates are rising in communities of color. Can these innovators help?
Scientists aren’t sure what’s behind the upward trend. That’s why Johnson & Johnson Innovation put out the call to address this troubling health disparity.
An estimated 3.1 million Americans live with inflammatory bowel disease (IBD), an umbrella term for two distinct autoimmune disorders—ulcerative colitis and Crohn’s disease—that cause chronic inflammation of the gastrointestinal tract.
But like so many diseases, it doesn’t strike all populations equally.
Historically, the prevalence of IBD has been highest in non-Hispanic white individuals. Yet research suggests that incidence and prevalence have surged among people of color in the United States. From 1970 to 2010, cases of IBD increased 39% among white Americans. For people who identify as Black and Hispanic, rates of the condition rose 134% in that time period.
The reason for the disproportionate increase in cases isn’t clear, in part because of limited clinical research specifically focused on IBD patients from underserved communities. There’s also a lack of data about the health outcomes of people of color living with the disease. And the disparity might be the result of people of color being underdiagnosed with IBD due to lack of diversity in clinical trials recruitment—as underscored in research published in the journal Gastroenterology in September 2021.
Though IBD can be managed with treatment, it could also pose a serious threat to overall health. Symptoms like diarrhea, fatigue and abdominal pain don’t just affect quality of life. People with IBD have a higher risk of developing other medical conditions, such as depression and cancer.
To address the disparity, Johnson & Johnson Innovation, together with Johnson & Johnson Innovative Medicine, launched the IBD QuickFire Challenge: Innovating for Health Equity. Earlier this year, U.S.-based companies, entrepreneurs and researchers were invited to submit data-driven tools or technologies that can better address the challenges of IBD, specifically aiming to improve outcomes in communities of color.
Applicants across the nation proposed potential tools and therapies. Three awardees were announced on December 4, which marks the beginning of Crohn’s and Colitis Awareness Week.
The makers behind these innovations will receive grant funding from a total pool of $250,000 and access to the global Johnson & Johnson Innovation-JLABS network, plus mentorship from scientists and researchers across Johnson & Johnson.
Learn about these three potential solutions—and the innovators behind them—and how they could help close the IBD equity gap.
A simple blood test to diagnose IBD
Michael Mahler has been interested in autoimmune diseases ever since he completed his doctoral degree. “The idea that some people have immune systems that get out of control and attack the body’s own structures fascinated me,” says the vice president of R&D and business development for Werfen, a specialized diagnostics company in San Diego that helps hospitals and labs improve patient care.
His interest in IBD is also a personal one; a family member lives with IBD-like symptoms. “It’s very challenging to make a diagnosis,” he says, of the battery of tests people with symptoms must endure. “The pathway is very, very difficult and draining.” That’s especially true for people of color, he adds, who may face access barriers during the diagnosis process.
The awarded innovation: A simple blood test to help determine if a person has ulcerative colitis or Crohn’s disease
How it works: A blood sample is scanned for a unique biomarker, PR3-ANCA. In 2012, Mahler and the team found that patients with ulcerative colitis tested positive for this biomarker; in the years since, he’s gathered more evidence that PR3-ANCA is present in patients who have an active and severe case of ulcerative colitis. His study results have been replicated by scientists globally.
“Our goal is to make this blood test a standard test for patients suspected of having IBD,” says Mahler. The earlier a person knows which form of the condition they have, he explains, the earlier doctors can help patients make the right treatment decisions.
How the QuickFire Challenge award could help: “Because we are a specialized diagnostic company, we know a little bit about clinical trials, but we need the engagement of Johnson & Johnson experts,” says Mahler. Having access to the company’s existing clinical trial samples and/or working with Johnson & Johnson scientists to design new inclusive trials can potentially assist in accelerating the timeline for making the blood test available to the public, he adds.
What success will look like: “The first step to making this project successful is confirming that the biomarker differentiates ulcerative colitis from Crohn’s disease effectively in individuals from communities of color,” says Mahler. “Obtaining this data can then guide treatment decisions that have the potential to improve patient care.”
A digital platform to connect clinical trials to communities of color
Working as a clinical scientist in drug discovery at academic institutions and pharmaceutical companies, Kelvin Brown noticed something troubling: Trials recruited people of color at glacially slow rates. Often, individuals weren’t interested in joining, or they would quickly drop out because they didn’t anticipate that participation would be time-consuming.
Yet the data he saw highlighted the fact that digestive disorders like IBD were a growing health problem in underserved communities. So Brown, who’s based in Ohio, founded his own company, Karneyium Health, to build a digital platform that helped clinical trials reach diverse racial and ethnic groups.
The awarded innovation: a digital platform that makes clinical trials more accessible to communities of color
How it works: Karneyium Health is an AI-driven clinical trial platform that can be used by pharmaceutical companies looking to find more diverse participants and sites. It can also be accessed by healthcare professionals in community health centers, federal medical centers and VA hospitals who want to run a clinical trial of their own. The platform combines a geographic information system with vital health data to show health and disease trends across multiple regions. Additionally, it’s designed to streamline site selection and lessen the administrative workload for physicians, simplifying their search for suitable clinical trial patients.
We want to help further the process of democratizing clinical trials in hospitals that are generally excluded from research opportunities—that’ll be a huge win for us.
How the QuickFire Challenge award could help: “Because Johnson & Johnson is involved in so many clinical trials, they’re giving us a great arena to test our project and make sure that it’s superior for the people who are going to use it,” says Brown. He hopes to have onboarded 25 to 50 community health systems and hospitals and 15 to 20 pharmaceutical companies by the time Karneyium Health launches in 2025.
What success will look like: “We want to help further the process of democratizing clinical trials in hospitals that are generally excluded from research opportunities—that’ll be a huge win for us,” Brown says. “We’ve realized that a lot of communities of color really don’t understand what clinical research is, and historically, it’s been something that they’re extremely uncomfortable with.” The data that Karneyium Health gathers can also be relayed back to clinical trial sponsors to help address some of those misunderstandings.
As the technology surrounding clinical trials continues to advance, “in the future, I really see a world where any community health system, rural healthcare center or nonacademic institution can take part in clinical trials,” says Brown. “That won’t just even the playing field when it comes to accessing clinical trials, but the outcomes themselves.”
A personalized autoimmune care team at your fingertips
Helping others has always been a driving force for Melanie Igwe. Drawing on her years of experience in healthcare management, she -founded DrugViu in 2019, a site that crowd-sourced medication reviews from people of color users. Research and user feedback led her to start thinking about ways to help people living with autoimmune conditions, such as IBD.
It’s a health concern she understands well. “I have an autoimmune condition, as do several of my family members,” says the Washington, D.C. resident. “There’s such an unmet need to address the health challenges they cause, and that really motivated me.” So Igwe and her team relaunched their company as ViuHealth, a digital health platform and app that offers “complete autoimmune day-to-day care management,” she explains.
The awarded innovation: ViuHealth, a digital health platform and mobile app that allows patients to manage their autoimmune or chronic condition with an expert-led virtual care team
How it works: The ViuHealth app helps navigate the daily challenges of living with an autoimmune condition, enabling patients to track symptoms, flares and medications all in one place.
To combat the depression and isolation that often accompany conditions like IBD, the app offers a suite of mindfulness tips and guided meditation, as well as the opportunity to connect with other users. A team of clinicians, including registered nurses and autoimmune-focused health coaches, provide one-on-one lifestyle coaching and create a comprehensive care plan that can then be shared with a user’s in-person healthcare providers.
“That way, the providers have enhanced visibility of what’s going on with their patients,” says Igwe. Users can also be matched to clinical trials relevant to their specific condition; a trial navigator guides them through the process.
How the QuickFire Challenge award could help: ViuHealth is only accessible to patients through their in-person healthcare providers. But seeing a provider might require an insurance copay, even for virtual visits—and that presents a financial burden that can block healthcare access.
“We want to make sure that we’re democratizing and providing as much access as possible,” says Igwe. The funding will also enable ViuHealth to onboard more providers who have experience treating people of color.
What success will look like: Reaching a place where patients from underserved communities are connected to new treatments and tools that help them live with an autoimmune condition and improve their quality of life.
“It’s really great to have award funding to get this program started,” says Igwe. “Our plan is to ensure we are continuously increasing access and make sure that all people have access to the best care possible.” Her moonshot goal: ViuHealth will play a role in innovating more effective treatments for people of color living with autoimmune diseases like IBD.