Abstract：
BACKGROUND: Previous studies have reported that rituximab (RTX) therapy might be beneficial in reducing relapse rates in patients with IgG4-related disease (IgG4-RD). Therefore, we aimed to systematically assess the efficacy and safety of RTX induction treatment and the effect of RTX maintenance in patients with IgG4-RD.
METHODS: The protocol was registered in the PROSPERO (CRD42023427352). PubMed, Embase, the Cochrane database, Scopus, and the Web of Science were interrogated to identify studies that evaluated the impact of RTX on prognosis in IgG4-RD. We explored the impact of various subgroups of factors on relapse outcomes and focused on the possible role of maintenance therapy in reducing relapse rates. The pooled incidence of adverse events of RTX therapy and the influencing factors have also been evaluated.
RESULTS: Eighteen studies comprising 374 patients (mean age 56.0 ± 8.7 years; male 73.7 %) with a mean follow-up duration of 23.4 ± 16.3 months were included. The pooled estimate of the response rate, complete remission rate, overall relapse rate, adverse event rate, and serious adverse event rate of RTX induction therapy were 97.3 % (95 % CI, 94.7 %-99.1 %), 55.8 % (95 % CI, 39.6 %-71.3 %), 16.9 % (95 % CI, 8.7 %-27.1 %), 31.6 % (95 % CI, 16.7 %-48.9 %) and 3.9 % (95 % CI, 0.8 %-8.9 %), respectively. In subgroup analysis, the pooled relapse rate was significantly lower in studies with maintenance than without maintenance (2.8% vs 21.5 %, p < 0.01). Pooled Kaplan-Meier relapse curves also demonstrated that RTX maintenance therapy provided a better prognosis.
CONCLUSIONS: RTX induction therapy appears to have satisfactory efficacy in the induction of remission in IgG4-RD. In addition, prophylactic RTX maintenance therapy after induction may be beneficial in preventing relapse of IgG4-RD.
METHODS: The protocol was registered in the PROSPERO (CRD42023427352). PubMed, Embase, the Cochrane database, Scopus, and the Web of Science were interrogated to identify studies that evaluated the impact of RTX on prognosis in IgG4-RD. We explored the impact of various subgroups of factors on relapse outcomes and focused on the possible role of maintenance therapy in reducing relapse rates. The pooled incidence of adverse events of RTX therapy and the influencing factors have also been evaluated.
RESULTS: Eighteen studies comprising 374 patients (mean age 56.0 ± 8.7 years; male 73.7 %) with a mean follow-up duration of 23.4 ± 16.3 months were included. The pooled estimate of the response rate, complete remission rate, overall relapse rate, adverse event rate, and serious adverse event rate of RTX induction therapy were 97.3 % (95 % CI, 94.7 %-99.1 %), 55.8 % (95 % CI, 39.6 %-71.3 %), 16.9 % (95 % CI, 8.7 %-27.1 %), 31.6 % (95 % CI, 16.7 %-48.9 %) and 3.9 % (95 % CI, 0.8 %-8.9 %), respectively. In subgroup analysis, the pooled relapse rate was significantly lower in studies with maintenance than without maintenance (2.8% vs 21.5 %, p < 0.01). Pooled Kaplan-Meier relapse curves also demonstrated that RTX maintenance therapy provided a better prognosis.
CONCLUSIONS: RTX induction therapy appears to have satisfactory efficacy in the induction of remission in IgG4-RD. In addition, prophylactic RTX maintenance therapy after induction may be beneficial in preventing relapse of IgG4-RD.
摘要：
背景：先前的研究报道利妥昔单抗（RTX）治疗可能有利于降低IgG4相关疾病（IgG4-RD）患者的复发率。因此,我们旨在系统评估IgG4-RD患者中RTX诱导治疗的有效性和安全性以及RTX维持治疗的效果.
方法：该方案已在PROSPERO（CRD42023427352）中注册。PubMed,Embase,Cochrane数据库,Scopus,我们询问了WebofScience，以确定评估RTX对IgG4-RD预后影响的研究。我们探讨了各种亚组因素对复发结果的影响，并重点研究了维持治疗在降低复发率中的可能作用。还评估了RTX治疗不良事件的汇总发生率和影响因素。
结果：纳入了18项研究，包括374例患者（平均年龄56.0±8.7岁；男性73.7%），平均随访时间为23.4±16.3个月。反应率的汇总估计，完全缓解率,总复发率，不良事件发生率,RTX诱导治疗的严重不良事件发生率为97.3%(95%CI,94.7%-99.1%),55.8%（95%CI，39.6%-71.3%），16.9%（95%CI，8.7%-27.1%），31.6%（95%CI，16.7%-48.9%）和3.9%（95%CI，0.8%-8.9%），分别。在亚组分析中，在有维持的研究中，合并复发率显着低于无维持的研究（2.8％vs21.5％，p<0.01)。汇集的Kaplan-Meier复发曲线也表明RTX维持治疗提供了更好的预后。
结论：RTX诱导疗法在诱导IgG4-RD缓解方面似乎具有令人满意的疗效。此外,诱导后的预防性RTX维持治疗可能有利于预防IgG4-RD的复发.
方法：该方案已在PROSPERO（CRD42023427352）中注册。PubMed,Embase,Cochrane数据库,Scopus,我们询问了WebofScience，以确定评估RTX对IgG4-RD预后影响的研究。我们探讨了各种亚组因素对复发结果的影响，并重点研究了维持治疗在降低复发率中的可能作用。还评估了RTX治疗不良事件的汇总发生率和影响因素。
结果：纳入了18项研究，包括374例患者（平均年龄56.0±8.7岁；男性73.7%），平均随访时间为23.4±16.3个月。反应率的汇总估计，完全缓解率,总复发率，不良事件发生率,RTX诱导治疗的严重不良事件发生率为97.3%(95%CI,94.7%-99.1%),55.8%（95%CI，39.6%-71.3%），16.9%（95%CI，8.7%-27.1%），31.6%（95%CI，16.7%-48.9%）和3.9%（95%CI，0.8%-8.9%），分别。在亚组分析中，在有维持的研究中，合并复发率显着低于无维持的研究（2.8％vs21.5％，p<0.01)。汇集的Kaplan-Meier复发曲线也表明RTX维持治疗提供了更好的预后。
结论：RTX诱导疗法在诱导IgG4-RD缓解方面似乎具有令人满意的疗效。此外,诱导后的预防性RTX维持治疗可能有利于预防IgG4-RD的复发.
