Loganathan Priyadarshini, Siby Ninette, Mohan Babu P, Gajendran Mahesh, Chandan Saurabh, Echavarria Juan, Saligram Shreyas, Adler Douglas G
Departments of Internal Medicine.
Long School of Medicine, UT Health Science Center, San Antonio, TX.
J Clin Gastroenterol. 2024 Sep 26. doi: 10.1097/MCG.0000000000002078.
IgG4 pancreaticobilliary disease (IgG4-PBD) typically shows a rapid improvement with glucocorticoid treatment, yet most patients experience a recurrence. Rituximab (RTX) has emerged as a hopeful approach to prevent relapses in IgG4-PBD. Nevertheless, there is a lack of data on the efficacy and safety of RTX in IgG4-PBD. In this study, we aim to perform a systematic review and meta-analysis to study the pooled efficacy of RTX in this patient population.
Multiple databases, including MEDLINE, SCOPUS, and Embase, were searched (in March 2024) using specific terms for studies evaluating the efficacy and safety of RTX in IgG4 pancreatic biliary disease. Outcomes of interest were relapse, remission, partial remission rates, and adverse events. Standard meta-analysis methods were used using the random-effects model. I2% heterogeneity was used to assess the heterogeneity.
Twelve studies were included in the study (257 patients). The pooled rate of complete remission was 68% (54% to 80%), I2 =53%, respectively. The pooled relapse rate was 23% (13% to 36%), I2=64%. The pooled rate of total adverse events was 21% (12% to 35%), I2=52%. The pooled partial remission rate is 16% (7% to 32%), I2=25%. The pooled rate of complete and partial remission was 81% (66% to 90%), I2=75%. The pooled infusion reaction and infection were 12% (7% to 18%), I2=0% and 14% (8% to 22%), I2=16%, respectively.
RTX therapy appears effective in inducing and maintaining remission of pancreaticobiliary disease with a low rate of side effects. RTX presents as a promising treatment option for patients grappling with recurrent or unresponsive IgG4-related ailments. In addition, RTX emerges as an attractive alternative for individuals intolerant to steroids or experiencing IgG4-related disease relapses. Future studies comparing RTX with other immunomodulators will offer deeper insights into relapse factors and elucidate the appropriateness of utilizing this maintenance treatment following the initial flare.
IgG4相关性胰腺胆管疾病（IgG4-PBD）通常在糖皮质激素治疗后迅速改善，但大多数患者会复发。利妥昔单抗（RTX）已成为预防IgG4-PBD复发的一种有希望的方法。然而，关于RTX在IgG4-PBD中的疗效和安全性的数据尚缺乏。在本研究中，我们旨在进行一项系统评价和荟萃分析，以研究RTX在该患者群体中的综合疗效。
使用特定术语检索了多个数据库，包括MEDLINE、SCOPUS和Embase（于2024年3月），以查找评估RTX在IgG4胰腺胆管疾病中的疗效和安全性的研究。感兴趣的结局包括复发、缓解、部分缓解率和不良事件。使用随机效应模型采用标准的荟萃分析方法。I2%异质性用于评估异质性。
该研究纳入了12项研究（257例患者）。完全缓解的合并率分别为68%（54%至80%），I2 = 53%。复发的合并率为23%（13%至36%），I2 = 64%。总不良事件的合并率为21%（12%至35%），I2 = 52%。部分缓解的合并率为16%（7%至32%），I2 = 25%。完全缓解和部分缓解的合并率为81%（66%至90%），I2 = 75%。输注反应和感染的合并率分别为12%（7%至18%），I2 = 0%和14%（8%至22%），I2 = 16%。
RTX治疗在诱导和维持胰腺胆管疾病缓解方面似乎有效，且副作用发生率低。对于患有复发性或难治性IgG4相关疾病的患者，RTX是一种有前景的治疗选择。此外，对于不耐受类固醇或经历IgG4相关疾病复发的个体，RTX是一种有吸引力的替代方案。未来比较RTX与其他免疫调节剂的研究将更深入地了解复发因素，并阐明在初始发作后使用这种维持治疗的适宜性。
