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利妥昔单抗作为天疱疮的辅助治疗:来自单一中心61例患者的长期随访经验。

Rituximab as an adjuvant therapy for pemphigus: experience in 61 patients from a single center with long-term follow-up.

作者信息

Sharma Vinod K, Gupta Vishal, Bhari Neetu, Singh Vishwajeet

机构信息

Department of Dermatology and Venereology, All India Institute of Medical Sciences, New Delhi, India.

Department of Biostatistics, All India Institute of Medical Sciences, New Delhi, India.

出版信息

Int J Dermatol. 2020 Jan;59(1):76-81. doi: 10.1111/ijd.14546. Epub 2019 Jun 30.

Abstract

BACKGROUND

Rituximab is increasingly being used as an adjuvant treatment for recalcitrant or relapsed pemphigus, but information on its use as a first-line agent is limited. We describe the long-term effectiveness and safety of rituximab in the treatment of pemphigus and compare the treatment outcomes when rituximab is used as first-line treatment vis-à-vis after treatment failure or relapse.

METHODS

This was a retrospective review of 61 patients with pemphigus treated with rituximab at our center from March 2012 to October 2018.

RESULTS

Of the 61 patients, 51 achieved complete remission (on or off treatment) and 10 had partial remission. Forty-nine (80.33%) patients achieved complete remission off prednisolone over a mean period of 8.08 ± 4.45 (range 3-20) months. Seventeen (27.9%) patients relapsed after a mean period of 23.94 ± 13.15 months after first rituximab cycle and 15.97 + 13.7 months after stopping prednisolone. Treatment-related serious adverse effects were noted in six (9.8%) patients. Eighteen (29.5%) patients were administered rituximab as the first-line adjuvant, while 43 (70.5%) patients received it after treatment failure or relapse. In both groups, remission rates on prednisolone (88.9%, 81.4%) and off prednisolone (88.9%, 76.7%) were comparable (P > 0.05). Relapse rates in the group which received rituximab as first-line treatment were about half of those who received rituximab after relapse or treatment failure (16.7% vs. 32.6%, P = 0.348). No statistically significant difference was seen in the times to different treatment endpoints (disease control, complete remission on and off prednisolone, and relapse) between the two groups.

CONCLUSIONS

Rituximab is a safe and effective adjuvant in the treatment of pemphigus. Treatment outcomes were better for patients who received rituximab as first-line treatment, but the difference was not statistically significant.

摘要

背景

利妥昔单抗越来越多地被用作顽固性或复发性天疱疮的辅助治疗药物,但关于其作为一线治疗药物的使用信息有限。我们描述了利妥昔单抗治疗天疱疮的长期有效性和安全性,并比较了利妥昔单抗作为一线治疗与治疗失败或复发后使用时的治疗效果。

方法

这是一项对2012年3月至2018年10月在我们中心接受利妥昔单抗治疗的61例天疱疮患者的回顾性研究。

结果

61例患者中,51例实现完全缓解(治疗中或治疗后),10例部分缓解。49例(80.33%)患者在平均8.08±4.45(3 - 20)个月内停用泼尼松龙后实现完全缓解。17例(27.9%)患者在首个利妥昔单抗疗程后平均23.94±13.15个月、停用泼尼松龙后15.97 + 13.7个月复发。6例(9.8%)患者出现与治疗相关的严重不良反应。18例(29.5%)患者接受利妥昔单抗作为一线辅助治疗,43例(70.5%)患者在治疗失败或复发后接受该治疗。两组中,泼尼松龙治疗时的缓解率(88.9%,81.4%)和停用泼尼松龙后的缓解率(88.9%,76.7%)相当(P>0.05)。接受利妥昔单抗作为一线治疗的组的复发率约为复发或治疗失败后接受利妥昔单抗治疗组的一半(16.7%对32.6%,P = 0.348)。两组在达到不同治疗终点(疾病控制、泼尼松龙治疗中和治疗后完全缓解以及复发)的时间上无统计学显著差异。

结论

利妥昔单抗是治疗天疱疮的一种安全有效的辅助药物。接受利妥昔单抗作为一线治疗的患者治疗效果更好,但差异无统计学意义。

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