Background: Autoimmune cholestatic liver diseases (AICLDs), including primary biliary cholangitis (PBC) and primary sclerosing cholangitis (PSC), are characterized by progressive biliary injury and cholestasis, leading to an impaired quantity/quality of life. Pruritus affects 20–70% of patients and is often refractory to current treatments.
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Background: Autoimmune cholestatic liver diseases (AICLDs), including primary biliary cholangitis (PBC) and primary sclerosing cholangitis (PSC), are characterized by progressive biliary injury and cholestasis, leading to an impaired quantity/quality of life. Pruritus affects 20–70% of patients and is often refractory to current treatments. Ileal bile acid transporter (IBAT) inhibitors reduce bile acid reabsorption and may alleviate cholestatic pruritus. This systematic review and meta-analysis evaluates their efficacy and safety in adults with AICLD.
Methods: Following PRISMA guidelines, we systematically searched PubMed, Embase, and Cochrane-CENTRAL for studies assessing IBAT inhibitors in adult AICLD patients with pruritus for ≥12 weeks. The primary outcome was the change in the 5-D Pruritus Scale. Secondary outcomes included sleep quality, serum bile acids, liver biochemistry, and safety. Heterogeneity was assessed using Cochrane Q and I
2 statistics.
Results: Three studies (
n = 180) met inclusion criteria, including two RCTs and one single-arm study. Patients (78% female; 85% PBC; 77% linerixibat) showed a significant pruritus reduction (MD = −4.93, 95%CI [−6.26, −3.59],
p < 0.0001), accompanied by improved sleep quality (MD = −8.12, 95%CI [−13.54, −2.70],
p = 0.0033). Serum bile acids, FGF19, and autotaxin decreased significantly, with increased C4 levels. AST and GGT declined, while ALP, ALT, and bilirubin remained stable. Adverse events occurred in 89.7%, mainly diarrhea (22.7%), nausea (12.2%), and abdominal pain (18.2%); serious events were rare (2.2%).
Conclusions: IBAT inhibitors significantly reduce pruritus and improve sleep in AICLD, with a favorable safety profile. These findings support their potential as a novel therapeutic option for cholestatic pruritus in adults with AICLD.
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