The term “revolutionary” is used too often in health care. New imaging modalities, pharmaceutical breakthroughs, advanced medical devices, and artificial intelligence are all regularly proclaimed to be revolutionary to attract interest and attention. But those of us trained in medicine who work in these fields know that revolutions don’t happen—it takes 17 years for new research to reach the translational stage.
In reality, the best we can hope for is a fast evolution of clinical practices. Even the new class of metabolic modulators and weight loss treatments, including Zepbound and Wegovy, which can potentially bring global obesity rates down, are based on compounds developed a dozen years ago. However, when there is critical mass—”moonshot” alignment—across health care innovators, providers, policymakers, and payers, we can increase the pace of health care’s evolution and deliver patients relief very quickly.
Advances in imaging and diagnosis of MASH
That’s why what is happening today in liver care is so exciting. We are at the nexus of several concurrent advancements in imaging and pharmaceutical development that will significantly advance the evolution of clinical care for how patients with metabolic dysfunction-associated steatohepatitis (MASH) are diagnosed, treated, and monitored. For those unfamiliar with MASH, it is a form of fatty liver disease that can cause scarring in the liver, potentially leading to cirrhosis and the need for a transplant or death. Importantly, MASH is a treatable risk factor for heart disease (like cholesterol), is driven by obesity, and affects a third of the global population.
Previously, MASH was confirmed through liver biopsy, but thanks to advances in imaging, patients can now avoid the pain, inconvenience, and the 2.4 percent risk of major complications from a large needle being stuck into their liver. What’s more, if the biopsy misses the most affected part of the liver and/or the pathologists disagree on the results, a patient might be left with an inaccurate diagnosis. Recent imaging modalities have fewer limitations. Seeing the liver, in totality, with detailed data visualizations of the organ, helps physicians and patients see the affected areas, and as treatment progresses, advanced imaging can quantify the impact of treatment and predict outcomes. Upstream MRI, blood tests, and ultrasound elastography can also identify MASH without biopsy in a community setting, which is important because MASH is largely asymptomatic.
First FDA-approved treatment for MASH in 40 years
Concurrent with these advances in imaging, pharmaceutical companies are pursuing new treatments for MASH. Recently, after 15 years of development, the FDA approved Madrigal’s drug Rezdiffra for MASH. Prior to that, there were no effective treatments in the 40 years since MASH was identified. While Madrigal was the first company to receive approval for a MASH drug, several other companies, including Akero Therapeutics, 89 Bio, and Viking Therapeutics, are all expected to seek approval for MASH drugs in the next few years. Joining the research push in this area are the makers of the GLP-1 weight loss drugs, which are also exploring their products’ viability in treating MASH.
Perhaps recognizing the important role imaging now plays in clinical trials for MASH drugs clinical trials, the FDA determined liver biopsies are not necessary for physicians to prescribe Rezdiffra. This is a moment in the evolution of MASH care that we will look back on in 10-15 years and recognize how everything has changed. Importantly, integrating scans into current and ongoing MASH therapeutic clinical trials has made it easier to introduce new MASH drugs into physician workflows.
Improving the patient journey
Using newer medical imaging products has shortened the diagnostic journey that used to take days and involve liver biopsies. Now diagnosis can be achieved in a couple of hours, allowing patients to begin treatment sooner. With the recognition that imaging results are equivalent to biopsies, noninvasive annual or semiannual scans will help physicians monitor and further customize treatment, if necessary, without inflicting unnecessary biopsy pain and risk on patients.
Madrigal spent 15 years developing Rezdiffra, and other companies will have similar timelines once their compounds are reviewed by the FDA. The use of quantitative MRIs and biomarkers to map liver disease was researched and clinically validated more than a dozen years ago. Other modalities like ultrasound elastography have been around longer. Fortunately for physicians and patients, continued advances in imaging-based diagnosis and the approval of new therapeutics are happening concurrently. Revolutions may not happen in health care, but these two exciting developments mean co-evolution is occurring, and it’s only going to get better. The use of medical imaging modalities in the lifecycle of MASH drug development and clinical care will unlock significant growth in imaging. But as important, imaging’s role in MASH can serve as an example to drug developers of how working in tandem with imaging can evolve the science of imaging to support the development of new therapeutics and, ultimately, better clinical practice.
Rajarshi Banerjee is a physician executive.
