The conversation focuses on advances in research, collaboration and insight creation the entire MASLD research community has made in 2023 and what this new perspective portends for the future of MASLD research.
Michelle starts by using the word “momentum” to characterize the MASLD research community in 2023. She says the pace of change makes it impossible to summarize or describe the year easily, For example, the adoption of new nomenclature came six months ago at EASL, but it feels like it was far longer than that. Roger compares the optimism in the field to 2019 while awaiting what was the anticipated approval of OCA. Today, he notes, the entire community understands so much more about MASLD and has so much more confidence in resmetirom than in OCA that we see optimism about future drug developments along with a greater appreciation of the potential scale of the global crisis around MASLD.
Michelle comments that in the aftermath of OCA, the scientific community has been “willing to adapt and eat humble pie.” Today, we see proposals for future studies that demonstrate how fast researchers are adopting new knowledge and using it in new study designs. In particular, she notes that the year’s FDA workshop showcased a shift in drug development strategies and a deeper understanding of surrogate endpoints, reflecting a desire within the field to embrace new insights for advancement.
Louise adds to the dialogue by discussing the swift adoption of new terminology and the integration of noninvasive diagnostic technologies, emphasizing the patient’s perspective and the importance of comprehensible communication about their health condition. She advocates for broader inclusivity in future Delphi processes, specifically seeking greater involvement for nurses and allied health professionals, groups that provide line communication with patient communities.
Roger notes a newfound humility within the academic medical community that promotes collaboration and ongoing improvement. Michelle agrees, stressing the need to dismantle barriers such as pride and the critical role of cross-sector collaboration in addressing the field’s unmet needs and the lack of approved therapies. She designates 2023 as a turning point, with a shift toward a more open, conservative, and cooperative mindset in the scientific community, departing from previous attitudes.
The discussion moves to the intricacies of interpreting histology data from clinical trials, where Michelle points out the importance of a nuanced understanding of such data, including the timing of biopsies and the correlation with noninvasive testing results.
As an example of the new nuances, Roger cites bariatric data shared at EASL suggesting that it takes five years for the liver fat reduction associated with bariatric surgery to translate into a one-level regression of fibrosis and a HistoIndex study suggesting a consistent “true” placebo rate of 34%, which is far higher than we see in drug studies. Michelle acknowledges that aligning the ideal scientific method with business realities is a pivotal, realistic challenge. The group concludes with predictions for 2024, expecting significant advancements, possibly including new therapy approvals. Despite potential obstacles, there is a shared optimism for rapid progress and enhanced collaboration in hepatology research and clinical practice.