Impact of a Novel Digital Therapeutics System on Nonalcoholic Steatohepatitis: The NASH App Clinical Trial

Abstract

INTRODUCTION: Management of nonalcoholic steatohepatitis (NASH) is a currently unmet clinical need. Digital therapeutics (DTx) is an emerging class of medicine that delivers evidence-based therapeutic interventions. This study was aimed at investigating the efficacy of DTx in patients with NASH. METHODS:We conducted a multicenter, single-arm, 48-week trial in 19 patients with biopsy-confirmed NASH. All patients received a DTx intervention with a newly developed smartphone application. The primary endpoint was change in the nonalcoholic fatty liver disease activity score (NAS) without worsening of liver fibrosis. The secondary endpoints included improvement of the NAS by ‡2 points without worsening of liver fibrosis, change in the body weight, and regression of fibrosis. RESULTS:After the 48-week DTx intervention, improvement of the NAS was observed in 68.4% (13/19) of patients. The mean change in the NAS from baseline to the end of the intervention was 22.05 6 1.96 (P < 0.001 when compared with the threshold of 20.7). A decrease in the NAS by ‡ 2 points was achieved in 11 (57.9%). The average weight loss at the end of the intervention was 8.3% (P < 0.001). Reduction of the fibrosis stage was observed in 58.3% when the analysis was limited to patients with stage F2/3 fibrosis. There were no serious adverse events that could be considered as being related to the DTx intervention.DISCUSSION:DTx for NASH was found to be highly efficacious and well-tolerated. Further evaluation of the DTx intervention for NASH in a phase 3 trial is warranted.

A Promising Digital Therapeutics for Nonalcoholic Steatohepatitis: More Efforts Are Needed

“…It is with sincere gratitude that we read the comment to our article by Seidita et al (1). We appreciate their contribution made to the topic of anemia in celiac disease (CD) through their recently published paper and also with their valuable comments on our publication (2,3).…”

“…We read with interest a recent article by Sato et al (1), which was the first trial of digital therapeutics (DTx) intervention for patients with nonalcoholic steatohepatitis (NASH), using the histological outcomes as end points. This study found that after 48 weeks of DTx intervention, 19 patients with liver biopsy-confirmed NASH lost an average of 8.3% of their body weight, with the majority showing improved liver steatosis status and fibrosis limited to stage F2/3.…”

Practical Lifestyle Management of Nonalcoholic Fatty Liver Disease for Busy Clinicians

“…Indeed, the use of digital devices for health interventions is increasing, and smartphone apps can be used for self-monitoring, participating in educational and counseling sessions, and communicating with clinicians, other health care professionals, and peer support networks. Efficacy trials of such digital apps are beginning in patients with NAFLD ( 75 ). A lifestyle modification checklist for health care professionals is provided in Table 1 , and a lifestyle management algorithm for NAFLD is depicted in Figure 1 .…”

A global research priority agenda to advance public health responses to fatty liver disease

“…The use of digital technologies in healthcare settings holds great potential for supporting service delivery, 67 yet this is a relatively new area of research within the field of fatty liver disease. [68][69][70][71] The panel supported the exploration of how novel digital technologies can be utilised within healthcare settings (priority 2.5) and further exploration of the potential for artificial intelligence methods to improve diagnosis of fatty liver disease (priority 2.7). The panel also supported further understanding how digital health approaches can support patients to achieve lifestyle behavioural change (priority 2.6).…”