Publication: Horizon scanning of therapeutic modalities for nonalcoholic steatohepatitis
Issued Date
2021-09-01
Resource Type
ISSN
16652681
Other identifier(s)
2-s2.0-85100608446
Rights
Mahidol University
Rights Holder(s)
SCOPUS
Bibliographic Citation
Annals of Hepatology. Vol.24, (2021)
Suggested Citation
Chanthawat Patikorn, Sajesh K. Veettil, Pochamana Phisalprapa, Tuan Pham, Kris V. Kowdley, Nathorn Chaiyakunapruk Horizon scanning of therapeutic modalities for nonalcoholic steatohepatitis. Annals of Hepatology. Vol.24, (2021). doi:10.1016/j.aohep.2021.100315 Retrieved from: https://repository.li.mahidol.ac.th/handle/123456789/77935
Research Projects
Organizational Units
Authors
Journal Issue
Thesis
Title
Horizon scanning of therapeutic modalities for nonalcoholic steatohepatitis
Abstract
Many interventions have been investigated for the treatment of nonalcoholic steatohepatitis (NASH). This study aims to summarize all investigated options to date and review the use of specific endpoints at different stages of ongoing trials of noncirrhotic NASH treatments. Using a horizon scanning approach, evidence were identified including meta-analyses of randomized controlled trials (RCTs) in PubMed, EMBASE, Cochrane, and AMED (up to February 2020), recently published RCTs in PubMed (2015-April 2020), RCTs presented at conferences (AASL and EASL, 2015–2020), and ongoing RCTs in ClincalTrials.gov (2015-November 2020). We included 6 meta-analyses of RCTs, 30 published RCTs, 11 conference abstracts, and 62 ongoing RCTs. An evidence map was created to demonstrate the treatment effects of 49 therapeutic modalities for NASH. Only six interventions (6/49, 12.24%) met the histological surrogate endpoints for potential conditional FDA approval. Obeticholic acid is the only therapy demonstrating positive benefits in ≥1-point improvement in fibrosis with no worsening of NASH in a phase 3 trial. The other therapies were all phase 2 studies. ≥1-point improvement in fibrosis with no worsening of NASH was shown in patients treated with cenicriviroc. NASH resolution with no worsening of fibrosis was shown in patients treated with liraglutide, semaglutide and resmetirom. Lanifibranor achieved both surrogate histological endpoints. Five ongoing RCTs (5/62, 8.06%) will investigate histological progression to cirrhosis, death, or liver-related clinical outcomes. In conclusion, some therapeutic modalities showed promising benefits, but further studies are warranted to find a definite treatment of NASH which prevents progression to cirrhosis and adverse liver outcomes.