Bezafibrate and linerixibat may be viable second-line therapies for pruritus among patients with primary biliary cholangitis (PBC), especially for those with moderate to severe pruritus, according to study results published in the Journal of Clinical Gastroenterology.
Researchers searched publication databases for double-blind, randomized, placebo-controlled clinical trials of pharmacological management for PBC, focusing on the common symptom of pruritis. A total of 33 studies that evaluated 20 medications were included in the analysis.
Using the primary outcome of postintervention pruritis score, rifampin (standardized mean difference [SMD], -3.29), bile acid binding agents (SMD, -2.30), and bezafibrate (SMD, -1.05) were favored over placebo, and cholestyramine (SMD, -0.94), flumecinol (SMD, -0.64), methotrexate (SMD, -0.20), ursodeoxycholic acid (UDCA; SMD, -0.11), and seladelpar (SMD, 0.03) were not favored over placebo.
For change in pruritis score from baseline, nalfurafine hydrochloride (SMD, -0.58), elafibranor (SMD, -0.57) and ileal bile acid transporter (IBAT) inhibitors (SMD, -0.22) were favored over placebo, and gabapentin (SMD, -1.91), seladelpar (SMD, -0.49), NGM282 (SMD, -0.23), UDCA (SMD, 0.03), and saroglitazar (SMD, 0.26) were not.
A total of 27 trials including 17 medications reported adverse events. Compared with placebo, risk for adverse events was associated with malotilate (risk ratio [RR], 21.69; 95% CI, 1.32-356.47; P =.031). Stratified by individual studies, adverse event risk was elevated in a single study of methotrexate (RR, 21.30; 95% CI, 1.40-324.87), linerixibat (RR, 4.03; 95% CI, 2.06-7.89), and maralixibat (RR, 1.61; 95% CI, 1.00-2.58) compared with placebo.
Study limitations include the high heterogeneity of studies and small sample size.
“This meta-analysis showed that bezafibrate and linerixibat should be considered as potential second-line therapies for pruritus in patients with PBC, particularly in those with moderate to severe itching,” the study authors wrote. “Further research is required to confirm the efficacy of seladelpar as recent data has shown promising results.”
Disclosure: One study author declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of the author’s disclosures.
Medina-Morales E, Bernal RB, Gerger H, et al. Pharmacological therapy of pruritus in primary biliary cholangitis: a Systematic review and meta-analysis of randomized clinical trials. J Clin Gastroenterol. Published online November 18, 2022. doi:10.1097/MCG.0000000000001797