The Efficacy and Safety of Seladelpar for Primary Biliary Cholangitis: A Systematic Review and Meta-Analysis

IF 1.5 Q3 GASTROENTEROLOGY & HEPATOLOGY

JGH Open Pub Date : 2025-08-28 DOI:10.1002/jgh3.70265

Mohamed Abuelazm, Saqr Alsakarneh, Mohammad Tanashat, AlMothana Manasrah, Ahmed A. Ibrahim, Sandesh Parajuli, Hatem Eltaly, Ahmed Mazen Amin

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Abstract

Background and Objective

Seladelpar is an oral, once-daily medication that improves cholestasis through its selective peroxisome proliferator-activated receptor (PPAR-δ) agonism. It shows promising efficacy in treating primary biliary cholangitis (PBC) patients.

Methods

A systematic review and meta-analysis synthesizing evidence from randomized controlled trials (RCTs) obtained from PubMed, Cochrane, Scopus, and WOS until July 19th, 2025. Dichotomous outcomes were reported using risk ratio (RR) and continuous outcomes using mean difference (MD), with a 95% confidence interval (CI).

Results

Three RCTs with 499 patients were included. Seladelpar was significantly associated with an increased ALP normalization (RR: 21.12 with 95% CI [4.14, 107.58], p < 0.01), biochemical response (RR: 3.06 with 95% CI [2.00, 4.70], p < 0.01), and decreased pruritus NRS score change (MD: −1.47 with 95% CI [−2.73, −0.21], p = 0.02). Seladelpar was also significantly associated with a decreased incidence of pruritus (RR: 0.54 with 95% CI [0.31, 0.94], p = 0.03) but with an increased incidence of headache (RR: 3.37 with 95% CI [1.11, 10.23], p = 0.03). However, there was no significant difference between seladelpar and placebo regarding the incidence of any adverse events (RR: 0.96 with 95% CI [0.87, 1.06], p = 0.43).

Conclusion

Seladelpar improved liver biomarkers of cholestasis and reduced pruritus in patients with PBC without significantly increasing the adverse effects. This makes seladelpar a promising addition to the treatments available for PBC.

Trial Registration: PROSPERO: CRD42024521208

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Seladelpar治疗原发性胆道性胆管炎的有效性和安全性：一项系统综述和荟萃分析

背景与目的西拉得帕是一种口服，每日一次的药物，通过其选择性过氧化物酶体增殖物激活受体（PPAR-δ）激动作用改善胆汁淤积。它在治疗原发性胆管炎（PBC）患者中显示出良好的疗效。方法对截至2025年7月19日的PubMed、Cochrane、Scopus和WOS的随机对照试验（rct）进行系统评价和荟萃分析。使用风险比（RR）报告二分结果，使用平均差（MD）报告连续结果，95%置信区间（CI）。结果纳入3项随机对照试验，共499例患者。Seladelpar与ALP正常化升高（RR: 21.12, 95% CI [4.14, 107.58], p < 0.01）、生化反应（RR: 3.06, 95% CI [2.00, 4.70], p < 0.01）、瘙痒NRS评分变化降低（MD: - 1.47, 95% CI [- 2.73, - 0.21], p = 0.02）显著相关。西拉得帕还与瘙痒发生率降低显著相关（RR: 0.54, 95% CI [0.31, 0.94], p = 0.03），但与头痛发生率增加显著相关（RR: 3.37, 95% CI [1.11, 10.23], p = 0.03）。然而，在任何不良事件的发生率方面，seladelpar和安慰剂之间没有显著差异（RR: 0.96, 95% CI [0.87, 1.06], p = 0.43）。结论西拉得帕改善PBC患者胆汁淤积的肝脏生物标志物，减轻瘙痒，但不良反应未明显增加。这使得seladelpar成为PBC治疗的一个有希望的补充。试验注册：PROSPERO: CRD42024521208

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