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利妥昔单抗治疗东南亚天疱疮。

Rituximab Therapy for Treatment of Pemphigus in Southeast Asians.

机构信息

Division of Dermatology, Department of Medicine, Faculty of Medicine, Ramathibodi Hospital, Mahidol University, Bangkok, Thailand.

Graduate School of Srinakharinwirot University, Bangkok, Thailand.

出版信息

Drug Des Devel Ther. 2021 Apr 22;15:1677-1690. doi: 10.2147/DDDT.S306046. eCollection 2021.

Abstract

BACKGROUND

Rituximab provides more effective and less adverse effects than the standard dose of corticosteroids, but evidence on its efficacy and safety in the Thai population is lacking.

OBJECTIVE

To evaluate the efficacy and safety of rituximab in the treatment of pemphigus and also to determine prognostic factors linked to the treatment outcomes.

METHODS

Pemphigus patients who received rituximab from November 2017 to December 2020 were retrospectively reviewed. The outcome was evaluated by using early (end of consolidation phase [ECP]) and late endpoints (complete remission [CR] on/off therapy, immunological remission [IR], and relapse). Adverse events were noted. Prognostic factors associated with remission and relapse were analyzed.

RESULTS

Of 53 pemphigus patients, all attained ECP within 1.61 months. Almost 80% achieved CR on therapy within a median time of 6.36 months, while 33.9% reached CR off therapy in 19.74 months. Nearly half had IR within a median time of 6.88 months. Relapse occurred in 33.3% with a median time of 14 months. In multivariate analysis, receiving rituximab within 12 months of disease duration was more likely to achieve CR off therapy and IR (hazard ratio [HR] 3.79; 95% confidence interval [CI] 1.38, 10.42; P = 0.01 and HR 2.74; 95% CI 1.12, 6.69; P = 0.027, respectively), whereas older patients and positive anti-desmoglein 1 levels at the time of CR were predictive indicators for relapse (HR 1.07; 95% CI 1.01, 1.13; P = 0.036 and HR 4.38; 95% CI 1.24, 15.46; P = 0.022, respectively). The treatment-related adverse effects occurred in 33.9%.

CONCLUSION

Rituximab is effective and safe in Thai pemphigus patients. Early administration of rituximab was a predictor of clinical and immunological remission. Older age and persistently positive anti-Dsg1 were correlated with disease relapse.

摘要

背景

利妥昔单抗比标准剂量的皮质类固醇更有效且不良反应更少,但在泰国人群中其疗效和安全性的证据尚缺乏。

目的

评估利妥昔单抗治疗天疱疮的疗效和安全性,并确定与治疗结果相关的预后因素。

方法

回顾性分析 2017 年 11 月至 2020 年 12 月接受利妥昔单抗治疗的天疱疮患者。通过早期(巩固治疗结束时 [ECP])和晚期终点(治疗期间和停药后的完全缓解 [CR]、免疫缓解 [IR] 和复发)评估结局。记录不良事件。分析与缓解和复发相关的预后因素。

结果

53 例天疱疮患者均在 1.61 个月内达到 ECP。近 80%的患者在中位时间 6.36 个月内达到治疗期间的 CR,而 33.9%的患者在 19.74 个月时达到停药后的 CR。近一半的患者在中位时间 6.88 个月时达到 IR。33.3%的患者发生复发,中位时间为 14 个月。多变量分析显示,疾病发病后 12 个月内接受利妥昔单抗治疗更有可能达到停药后 CR 和 IR(风险比 [HR] 3.79;95%置信区间 [CI] 1.3810.42;P = 0.01 和 HR 2.74;95% CI 1.126.69;P = 0.027),而老年患者和 CR 时抗桥粒芯糖蛋白 1 水平阳性是复发的预测指标(HR 1.07;95% CI 1.011.13;P = 0.036 和 HR 4.38;95% CI 1.2415.46;P = 0.022)。治疗相关不良反应发生率为 33.9%。

结论

利妥昔单抗治疗泰国天疱疮患者有效且安全。早期使用利妥昔单抗是临床和免疫缓解的预测指标。年龄较大和持续抗桥粒芯糖蛋白 1 阳性与疾病复发相关。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e3ea/8075311/1e6d3b0164a3/DDDT-15-1677-g0001.jpg

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