The efficacy and safety of low-dose rituximab in the treatment of pemphigus vulgaris: a cohort study

Abstract

Background

Rituximab (RTX) is considered the first-line treatment for pemphigus vulgaris (PV), which is a B-cell-mediated acquired autoimmune disease. However, no consensus on the optimum dosage has been achieved.

Objectives

To investigate the efficacy and safety of low-dose RTX (a single infusion of 500 mg) for the treatment of PV, a cohort study was conducted for patients with PV, along with a 12-month follow-up following the administration of RTX.

Methods

Patients with moderate or severe PV were divided into group A (low-dose RTX combined with corticosteroids) and group B (corticosteroids alone). Data on complete remission (CR) rates, doses of corticosteroids, cumulative doses of corticosteroids at the third, sixth, and twelfth months, pemphigus disease area index and adverse effects (AEs) were collected.

Results

Forty-four patients with moderate or severe PV were enrolled in this study (19 in group A and 25 in group B). Patients treated with low-dose RTX had higher CR rates, lower doses of corticosteroids at the third, sixth, and twelfth months, lower cumulative doses of corticosteroids at the sixth and twelfth months, and fewer AEs than those who received corticosteroids alone.

Conclusions

This study indicated that low-dose RTX may be a beneficial and secure therapy option for patients with moderate to severe PV.

Keywords:

• Pemphigus vulgaris
• low-dose
• rituximab
• corticosteroids
• adverse events

Ethical approval

The study protocol was approved by the Ethics Committee of WCH, Sichuan University (2017, No. 96) and registered in the Chinese Clinical Trial Registry (ChiCTR 1800020382). The patients provided their written informed consent to participate in this study.

Author contributions

Wei Li contributed to the conception of the study and made constructive discussions in manuscript; Xingli Zhou, Tongying Zhan, Xiaoxi Xu mainly helped perform the study and wrote the manuscript; Tianjiao Lan performed the data analysis; Jinqiu Wang and Dengmei Xia helped perform the evaluations of PDAI and record the occurrence of AEs during the follow-up period; Hongxiang Hu, Yiyi Wang, Yue Xiao and Yuxi Zhou contributed to the collection of laboratory results and data recording.

Disclosure statement

No potential conflict of interest was reported by the author(s).

Data availability statement

The original contributions presented in the study are included in the article/supplementary material. Further inquiries can be directed to the corresponding authors.

Additional information

Funding

This work was supported by the National Natural Science Foundation of China (82304062) and the Postdoctoral Fund of Sichuan University (No. 2023SCU12065).