Department of Gastroenterology, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan.
Department of Clinical Laboratory Medicine, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan.
Am J Gastroenterol. 2023 Aug 1;118(8):1365-1372. doi: 10.14309/ajg.0000000000002143. Epub 2022 Dec 14.
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.
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.
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 -2.05 ± 1.96 ( P < 0.001 when compared with the threshold of -0.7). 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.
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.
非酒精性脂肪性肝炎（NASH）的治疗是目前尚未满足的临床需求。数字疗法（DTx）是一种新兴的药物类别，可提供基于证据的治疗干预措施。本研究旨在研究 DTx 在 NASH 患者中的疗效。
我们在 19 名经活检证实患有 NASH 的患者中进行了一项多中心、单臂、48 周的试验。所有患者均接受了一种新开发的智能手机应用程序的 DTx 干预。主要终点是在不加重肝纤维化的情况下，非酒精性脂肪性肝病活动评分（NAS）的变化。次要终点包括 NAS 改善≥2 分而不加重肝纤维化、体重变化和纤维化消退。
在 48 周的 DTx 干预后，68.4%（13/19）的患者观察到 NAS 的改善。从基线到干预结束时 NAS 的平均变化为-2.05±1.96（与-0.7 的阈值相比，P<0.001）。11 名患者（57.9%）达到了 NAS 下降≥2 分。干预结束时平均体重减轻 8.3%（P<0.001）。当分析仅限于 F2/3 纤维化阶段的患者时，观察到 58.3%的纤维化阶段减少。没有严重不良事件可以被认为与 DTx 干预有关。
DTx 治疗 NASH 被发现非常有效且耐受良好。需要进一步评估 NASH 的 DTx 干预在 3 期试验中的效果。
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