The edition · Gastroenterology & Hepatology
STRIDE showed acceptable toxicity in poor-prognosis HCC, and an expert panel set out how to use resmetirom and semaglutide for MASH
The single-arm SIERRA study gave durvalumab plus tremelimumab to patients usually excluded from HCC trials, with grade 3 or 4 treatment-related events in about one in five. An international panel maps diagnosis, choice and monitoring for the first two drugs licensed in the US for MASH fibrosis.
The edition in brief
In SIERRA, 111 patients with unresectable hepatocellular carcinoma and Child-Pugh B7/B8 liver function, ECOG performance status 2 or main portal vein tumour thrombosis received the STRIDE regimen of one tremelimumab dose plus durvalumab; grade 3 or 4 possibly treatment-related adverse events within six months occurred in 19.8% and objective response in 14.4%, lowest in the Child-Pugh B cohort (6.8%). An international expert panel review in Gut consolidates trial data and labels for resmetirom and semaglutide, both conditionally approved by the FDA for MASH with F2 to F3 fibrosis, covering non-invasive diagnosis, choice by phenotype, monitoring and switching. In a 10-day open-label randomised proof-of-concept study of 21 patients with diabetes and refractory cirrhotic ascites, empagliflozin raised urinary sodium by 92 mmol a day and halved paracentesis volume (0.6 vs 1.3 L/day). The Rome V global survey of 28,771 adults found 40.9% met criteria for at least one disorder of gut-brain interaction, matching Rome IV. The FDA recorded a supplement for the adalimumab biosimilar adalimumab-aqvh on 25 September. SIERRA is single-arm and the ascites study tiny; neither is definitive.
FDA supplement recorded for the adalimumab biosimilar Yusimry (adalimumab-aqvh)
This is a supplement to an existing adalimumab biosimilar licence; adalimumab use in IBD is unchanged.
An expert panel lays out diagnosis, choice and monitoring for resmetirom and semaglutide in MASH fibrosis
Use this panel framework to select and monitor MASH drug treatment in F2 to F3 fibrosis, starting from non-invasive staging.
Empagliflozin increased sodium excretion and halved paracentesis volume in a 10-day pilot
Treat empagliflozin for refractory ascites as research-stage; the signal is interesting but rests on 21 patients over 10 days.
Four in ten adults met Rome V criteria for a gut-brain disorder, matching Rome IV
Make positive diagnoses of gut-brain disorders using Rome V, including the newly recognised abdominal migraine and inability to belch.
Give albumin with large-volume paracentesis
Give 6 to 8 g of albumin per litre when more than 5 litres of ascites is drained.
STRIDE gave acceptable toxicity in poor-prognosis HCC usually excluded from trials, with modest response
Consider STRIDE in selected poor-prognosis HCC after multidisciplinary review, recognising acceptable toxicity but modest response, lowest in Child-Pugh B.
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