Surfing the MASH Tsunami

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This week, our conversation From the Vault features a special, single-interview episode to give listeners a chance to learn about Jörn Schattenberg in a different way as he became the permanent Key Opinion Leader on Surfing the NASH Tsunami earlier this year. 

The Surfing the NASH Tsunami seasons start with the calendar year, but our first episode posted on April 15, 2020. As we embarked on our third year, we wanted to give listeners a chance to get to know Jörn Schattenberg a bit differently than you would just from listening to episodes. Jörn discusses how he decided to become a hepatologist, why Stephen Harrison’s phrase “Greet ’em and Street ’em” has such resonance, the basic science work his laboratory in Maïnz does, and where he sees the podcast fitting into the future of Fatty Liver disease. Louise Campbell and Roger Green ask questions and share viewpoints in this fast-moving, two-part conversation.

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This week, our conversation From the Vault features a special, single-interview episode to give listeners a chance to learn about Jörn Schattenberg in a different way as he became the permanent Key Opinion Leader on Surfing the NASH Tsunami earlier this year. 

The Surfing the NASH Tsunami seasons start with the calendar year, but our first episode posted on April 15, 2020. As we embarked on our third year, we wanted to give listeners a chance to get to know Jörn Schattenberg a bit differently than you would just from listening to episodes. Jörn discusses how he decided to become a hepatologist, why Stephen Harrison’s phrase “Greet ’em and Street ’em” has such resonance, the basic science work his laboratory in Maïnz does, and where he sees the podcast fitting into the future of Fatty Liver disease. Louise Campbell and Roger Green ask questions and share viewpoints in this fast-moving, two-part conversation.

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Surfing the NASH Tsunami begins its year-end series to reflect on a momentous 2022 for NAFLD and Season 3 of the podcast. Leading this final conversation, Roger Green asks Jörn Schattenberg what has surfaced in the past several months with the various consortia, and particularly the retrospective analysis in NAIL-NIT. Jörn starts by commenting that non-invasive testing may have more momentum now than any other areas in research. He notes the increasing number of consortia and the role they play in shaping the scope of NITs. One impact has influenced change in the original focus of how NITs could replace biopsies. The shift explores how NITs can be validated by histology via reductions in ALT, MRI-PDFF and MRE metrics. For particular data of interest, Jörn goes back a year to a study from the NASH CRN that measured severity in terms of baseline histology and then produced ratios of decompensation at different fibrosis stages. He goes on to explain that data from the single-sponsor studies, such as the resmetirom MAESTRO data, produces faster results than the larger consortium studies. Louise Campbell asks whether or how we can measure the impact of patient behavior change on outcomes in these studies. Jörn notes that the researcher can include questionnaires and app-based assessments to accommodate these factors.

At the bottom of the hour, Roger asks the group for final thoughts on changes envisioned for the next year specifically in terms of pathways. Each panelist provides thought-provoking responses to presage what is aligned to be another progressive year for the field in 2023.   

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Surfing the NASH Tsunami begins its year-end series to reflect on a momentous 2022 for NAFLD and Season 3 of the podcast. In this conversation, Surfers Jörn Schattenberg, Louise Campbell and Roger Green continue to share their respective highlights.

Louise and Jörn begin by discussing some of the benefits of FibroScan in terms of how practitioners have come to use data more appropriately with the newer iterations of the product. As Louise points out, older machines tracked kilopascals only. This could help identify disease but not support liver health as effectively. Newer machines measure liver stiffness, providing more nuanced insights into overall health. Jörn raises a question: why test when virtually everyone with liver disease has NAFLD? He suggests a test offers inexpensive therapy in the form of enhanced patient education and self-care. Louise mentions from her experiences in Australia that people even forget the role the liver plays in metabolism. She emphasizes this is in a country where the Aboriginal populations have such exceptional documentation about liver disease and education tools, both of which Louise describes in some detail. Jörn speculates that FibroScan use in the German system will continue to be limited due to low levels of reimbursement, unless there is a patient co-pay. Louise speculates that costs will come down, using her experience in the UK to support her suggestion.

The remainder of the conversation stems from Roger’s question about how digital tools will integrate with FibroScan over time. Louise believes they can work together in driving patient motivation. From a different view, Jörn suggests that in the German system, where data transfer is highly inefficient, practitioners will be challenged to integrate the data from these tools into patients records. As a result, it will remain difficult to integrate the tools themselves into patient care. Lastly, Roger notes that electronic health record systems can essentially eliminate this issue, however someone needs to pay for developing them.

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Surfing the NASH Tsunami begins its year-end series to reflect on a momentous 2022 for NAFLD and Season 3 of the podcast. In this conversation, Surfers Jörn Schattenberg, Louise Campbell and Roger Green share their respective highlights.

All three agree that a return to in-person meetings offered both opportunities to reconnect and meet for the first time those who have been part of the podcast since launching in 2020. This leads Jörn to harken back to how the role of the podcast changed through the duration of the pandemic. At the outset, it was possibly one of the only places for colleagues to exchange and engage in regular discussion about pivotal medical issues. Today, he notes, while colleagues can once again meet fairly regularly at different meetings, the podcast remains a source of excitement and valuable discourse. Roger points out that the transition to on-site meetings actually coincided with a rise in listenership. This rise is attributed to the explosion of knowledge about drugs, devices and pathophysiology alongside burgeoning discussions around guidelines and care pathways.

The discussion next focuses on an announcement from Louise that NICE is expected to approve FibroScan for primary care under specific circumstances. In light of this news, the trio take a minute to review the history and process by which NICE came to modify its initial position on the subject. Jörn notes that FibroScan is not only a tool for detecting liver disease, but also that it provides patients with a way to improve liver health. As the conversation winds down, Louise, who is recording in Perth, describes that FibroScan use in Australia is late and limited, possibly contributing to the country’s rapid rise in NASH prevalence. 

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Surfers Jörn Schattenberg, Louise Campbell and Roger Green host the Season 3, Year-in-Review episode to reflect on major themes and takeaways from a momentous 2022 in NAFLD.

The trio begin by highlighting the rewarding return to in-person conferences and events, and meeting fellow surfers for the first time offline. In response to his stepping into the role of permanent co-host, Jörn comments on the value he has derived from engaging in the ongoing dialogue supported by podcasting - something that continues to excite him even as life reverts somewhat to pre-pandemic, face-to-face interactions. The transition to on-site meetings, Roger notes, actually coincided with a rise in listenership. This leads the group to suggest the density and quality of data emerging from the field as deserving of more space for discourse outside of meetings alone. Louise also points to the diversity of perspectives championed through these conversations. For her, bringing the strength of patients to pathway development is critical and something she enjoys tuning in for on the episodes where she is absent. Roger adds that this year, the platform has really broadened its scope beyond simply drugs.

Louise segues to the subject of non-invasive technologies, pointing to some new and exciting news: NICE is on its way to approve FibroScan for all primary care physicians in the UK, so long as the patient is in a liver pathway. This predominantly includes NAFLD, Hepatitis B and fibrosis over the age of 16. FibroScan is noted to often be confused with a radiology test and not properly recognized as a type of liver elastography. It is through education and the rewriting of a pathway that FibroScan can be effectively used to achieve earlier diagnosis in many more patients with liver disease, liver fibrosis and risk in metabolic health. Jörn suggests this breakthrough supports a cross-sectional correlation between driving wellness through patient lifestyle management and cutting costs, for example, through the reduction of incidence of diabetes. From a wider metabolic perspective, assessing health through liver fat is a powerful tool to be harnessed for patient empowerment and demonstrating the influence of lifestyle interventions.

The conversation continues to address the expanding aperture of insights available not only through FibroScan, but additional technologies contributing to patient empowerment. Digital apps amongst other tools hold the possibility to reinforce the recurring theme on this podcast that liver health needs to be measured and monitored in a preventative manner as opposed to an end-stage disease outcome. Roger and Jörn briefly discuss digital tools for automating and scheduling functions built within health care systems, comparing progress in Europe versus the US. Jörn adds that, provided feasibility regarding information security concerns, linking data on a holistic level would pave a tremendous step forward for the patient experience. Roger next shifts focus to ask Jörn for any updates on the NAIL-NIT retrospective analysis previously discussed in April. Jörn refers to his experience of contributing to the LITMUS Consortia and its aim to validate a biomarker to replace liver biopsy as an outcome in clinical trials. He notes both retrospective and emerging prospective data supported an improved understanding of how a biomarker is linked to histology, and how a changed biomarker is linked to a change in histology.

At the bottom of the hour, Roger asks the group for final thoughts on changes envisioned for the next year specifically in terms of pathways. Each panelists provides thought-provoking responses to presage what is aligned to be another progressive year for the field in 2023.  

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Lars Johannson’s 2021 Paris NASH presentation, “Innovations in Imaging Assessment of Fibrosis“,” introduced his audience to a dynamic, multidimensional view of tools that can show us how the liver works. His viewpoint combined with discussion on novel imaging tools and approaches creates an episode From the Vault that might leave you repeatedly thinking “Oh, Wow!” 

This conversation excerpt begins with a comment from Louise Campbell that this entire approach might play a significant role in moving us beyond the biopsy. Lars agrees, noting that studying fibrosis and fat reduction places too much emphasis on “what shouldn’t be'' in the liver instead of focusing on “what should be,” which are high functioning hepatocytes. To explore hepatocyte function, he discusses use of gadolinium contrast agents, more than 50% of which are taken up by hepatocytes. This provides a setting to combine dynamic functional inputs based on hepatocyte function with static measures based on stiffness and PDFF. This provides a truly dynamic look at liver disease, which is particularly important given the liver’s ability to regenerate. Stephen spends the last few minutes of the conversation discussing the results this approach can yield and contrasting it favorably to the techniques we use today, some of which are difficult to implement and none of which provide the richness of information achievable with the imaging techniques Lars describes.

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The Liver Forum aims to advance the regulatory sciences for the treatment of NAFLD/NASH and liver fibrosis by providing a neutral, independent venue for ongoing multi-stakeholder dialogue. Their work facilitates the best science-based decisions on how to study efficacy and safety in real-time by using collective knowledge and experience with therapies for advancing liver disease. In this final conversation, Executive Director Veronica Miller joins guest Manal Abdelmalek and co-host Jörn Schattenberg (both Steering Committee members) to discuss the Liver Forum, its unique processes and valuable work. 

Roger Green starts this conversation suggesting that the findings of the Placebo Arm Database Project need to translate into guidelines for researchers to formally standardize. Veronica describes elements of how the Forum is organizing the trial and what she considers some of the critical success factors for a placebo cohort. She notes this should benefit individual pharmaceutical sponsors because they can assess data in the context of placebo response and how to recruit patients for clinical trials. She also believes that if these metrics are feasible to implement, they will find ways into clinical practice as well. Manal notes that another benefit might be to give regulators access to larger data sets that mirror how the trials are done, leveraging resources and providing benchmarks at the same time. Jörn notes the Forum to be an open process and provides examples of what he considers to be some key benefits to this. Veronica concludes the main conversation by discussing the idea that a shared placebo arm might be possible and would have tremendous benefit. Roger poses the final question: each panelist provides the strongest takeaway for what they hope listeners glean from this episode. Surf on to find out more. 

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The Liver Forum aims to advance the regulatory sciences for the treatment of NAFLD/NASH and liver fibrosis by providing a neutral, independent venue for ongoing multi-stakeholder dialogue. Their work facilitates the best science-based decisions on how to study efficacy and safety in real-time by using collective knowledge and experience with therapies for advancing liver disease. Previously, Executive Director Veronica Miller had introduced ongoing work with the Placebo Arm Database Project, co-chaired by Manal Abdelmalek.

Jörn Schattenberg leads this conversation with the observation that in Manal's past appearances on the podcast, she has discussed the value of stabilizing disease. Jörn asks whether the Forum is creating new insights on that front. Manal circles back to the challenges presented by an inability to predict an a priori placebo response rate and several issues in managing samples through trials. She notes that if researchers can integrate placebo arms from multiple trials, this will lead to far larger data sets.  Additionally, this will strengthen the ability to create deeper insights and more robust solutions to issues surrounding the best way to manage and standardize these trial elements. From here, Jörn’s question shifts focus toward composite trial endpoints. After a brief discussion on this issue, the conversation turns to the value of AI and better controlled study analysis. Roger poses a question regarding reducing placebo rates. Manal suggests that the goal is not to lower placebo rates, but instead to standardize them in the most accurate ways possible. The conversation concludes with Jörn noting that he is constantly concerned about whether he is matching patient and trial to maximum benefit.

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Previously, Executive Director Veronica Miller explained how she arrived to the field of NAFLD and the history of the Liver Forum. This conversation begins with recollections from Manal Abdelmalek and Jörn Schattenberg on their respective introductions to the Liver Forum. Before the collaborative space existed, Manal points out that when industry first began to ponder NASH drugs there were no road maps for trial design or endpoints. Jörn then describes his first attendance of a Liver Forum meeting. He found the experience to be uniquely valuable for its welcoming diversity of stakeholder inclusion and participation. Today, he is on the steering committee. 

The remainder of the session revolves around the panelists’ responses to questions from Roger Green, beginning with the intentionality behind using the word “forum” to represent their work. Following, Veronica discusses an ongoing project aimed to develop research tools and metrics that can capture the richness available in a plethora of data emerging from NASH studies. She envisions the field of omics to potentially illuminate a myriad of patient-specific biomarkers. Comparatively, she deems the biopsy a “very blunt tool.” She goes on to note that the COVID-19 pandemic complicated the challenges of conducting trials and developing data. Stakeholders are now returning to sieve through huge quantities of emerging data, distilling them into lessons that will shape how we diagnose and treat Fatty Liver patients. At the end of this session, Veronica begins to introduce the Placebo Arm Database Project, co-chaired by Manal.