The ability to predict long-term outcomes using MR Elastography (MRE) and other non-invasive testing methods will be pivotal to drug development and, separately, to diagnosing, staging and monitoring patients. Alina presents highlights from Mayo’s recent CGH paper and lends her own significant experience in this area. As we learned last year, Ian leads or is involved in large population-based studies in Leeds, with considerable focus on how NITs can support patient treatment most successfully and cost effectively. This is a topic where all five panelists can contribute from unique perspectives reflecting their own experiences.
8:53 – Alina Allen begins to discuss recent Mayo Clinic publication “MRE for Prediction of Long-Term Progression and Outcome in Chronic Liver Disease.”
10:22 – Source of data for this retrospective analysis
11:33 – Discussion of results starts by discussing accuracy in pre-cirrhotic patients
13:05 – Key point: biomarkers can tell us more because they are continuous numbers, not two or three level models
14:08 – Stephen Harrison asks for specific numbers that listeners can use as rules of thumb for prediction
15:08 – Alina — a 1 point increase in kPa…more than doubles the risk of cirrhosis for pre-cirrhotic patients, increases risk of decompensation by 22% in compensated cirrhotics
18:53 – Ian Rowe describes results as “great because it speaks to the development of more personal risk stratification for patients.”
19:53 – Alina expands on the benefit for clinicians who need to treat and manage individual patients more intelligently and cost effectively
22:08 – Ian describes a study he and his team in Leeds are conducting that addresses similar issues.
24:09 – Alina raises question of how to monitor sub-F2 patients in hepatology and even primary care clinics
24:59 – Louise Campbell: same metrics will allow us to individualize terminal care and palliation sooner for patients whose livers will fail. Leads to a more in-depth discussion with Ian on what should happen in the UK today vs. what is happening.
27:39 – Alina describes palliative care in the US as “an area that needs a lot more work” and raises some of the challenges
30:13 – Stephen asks whether we can reverse engineer or analyze these results for FibroScan. Ian reports that his data suggests this is a more complicated challenge.
31:41 – Stephen asks about implications for endpoint designation in pre-approval outcomes studies, then suggests an alternate design with endpoints based on MRE
33:10 – Alina agrees with idea, referring to Scott Friedman’s point in S2 E51 about the genesis of NAFLD activity scores and fibrosis levels
34:45 – Alina: “I think this connection between what we currently use to what we need to move in the future is starting to get made” and paints a picture for what trials might look like.
36:15 – Stephen asks whether we know enough to propose a Subpart H endpoint that is not biopsy driven. He and Alina agree we are close to having one key endpoint proven: a 20% decreasae in MRE correlates to a 1 level decrease in fibrosis.