Falk Gastro Info 8 i 9/2023

Mirikizumab as induction and maintenance therapy for ulcerative colitis: The interleukin-23 antibody mirikizumab was more effective than placebo in inducing and maintaining clinical remission in patients with moderately to severely active ulcerative colitis in a phase III trial program. However, opportunistic infection or cancer occurred in a small number patients treated with mirikizumab.

Chronic hepatitis D: 45% combined virological and biochemical response on bulevirtide therapy for 48 weeks. The recently published 48-week data from the ongoing MYR301 trial demonstrate that bulevirtide (2 mg/day subcutaneously) leads to a combined virological and biochemical response in 45% of patients with chronic hepatitis D (HDV RNA undetectable or decline of at least 2 log₁₀ IU/ml and normalization of alanine aminotransferase). However, HDV RNA became undetectable in only 12% of patients.

Non-alcoholic steatohepatitis (NASH): Randomized study demonstrates superiority of bariatric-metabolic surgery over lifestyle modification plus best medical care. In the study, 70% of participants who underwent Roux-en-Y gastric bypass surgery or gastric sleeve surgery achieved histological resolution of NASH without worsening of fibrosis at 1 year of follow-up, compared to only 19% in the group with lifestyle modification and optimized medical therapy.

Advanced biliary tract cancer: Randomized, double-blind, placebo-controlled phase 3 trial demonstrates superiority of adding pembrolizumab to gemcitabine and cisplatin. In the recently published KEYNOTE-966 trial, the median overall survival was 12.7 months for pembrolizumab + gemcitabine/cisplatin compared to 10.9 months in the control group (placebo + gemcitabine/cisplatin). The adverse events were comparable.

Long versus short peroral endoscopic myotomy (POEM) for the treatment of achalasia: A shorter cut length of POEM as compared with the standard treatment (8 cm vs. 13 cm) saved some procedural time with similar efficacy and comparable rates of gastroesophageal reflux disease in a non-inferiority trial comprising 200 patients.

Upadacitinib induction and maintenance therapy for Crohn’s disease: The Janus kinase inhibitor Upadacitinib was superior to placebo in achieving clinical remission and endoscopic response in this phase 3 trial program.