Mycophenolate mofetil or tacrolimus compared with azathioprine in long-term maintenance treatment for active lupus nephritis

Abstract

This study aimed to evaluate the efficacy and safety of mycophenolate mofetil (MMF) or tacrolimus (TAC) compared with azathioprine (AZA) as maintenance therapy for active lupus nephritis (ALN). Patients with ALN who responded to 24 weeks of induction treatment were enrolled. Patients who received MMF or TAC as induction therapy continued MMF or TAC treatment during the maintenance period, whereas those who received intravenous cyclophosphamide were subjected to AZA treatment. The primary endpoint was the incidence of renal relapse. Secondary endpoints included extrarenal flares and composite endpoints (deaths, end-stage renal disease, or doubling of serum creatinine levels). A total of 123 ALN patients (47 in the MMF group, 37 in the TAC group, and 39 in the AZA group) were enrolled. The median follow-up time was 60 months. Ten MMF-treated patients, ten TAC-treated patients, and eight AZA-treated patients experienced renal relapses (P = 0.844). The cumulative renal relapse rates in the MMF group (P = 0.934) and TAC group (P = 0.673) were similar to the renal relapse rate in the AZA group. No significant difference in the incidence of severe adverse event was observed among the groups. Long-term maintenance therapies with MMF or TAC might have similarly low rates of renal relapse and similar safety profiles compared with AZA.

Keywords

lupus nephritis / mycophenolate mofetil / tacrolimus / maintenance therapy

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Acknowledgements

The present study was supported by the National Natural Science Foundation of China (No. 81170671), Shanghai Health and Family Planning Committee Hundred Talents Program (No. 2018BR37). The investigators wish to thank the study participants and individuals who made the trial possible.

Compliance with ethics guidelines

Qianying Zhang, Peng Xing, Hong Ren, Xiaonong Chen, Jingyuan Xie, Wen Zhang, Pingyan Shen, Xiao Li, and Nan Chen declare that they have no conflict of interest. The study was approved by the Ethics Committees of Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, and the registration number in the Chinese Clinical Trial Registry is ChiCTR-TRC-10000896. All patients signed written informed consent forms.

Electronic Supplementary Material

Supplementary material is available in the online version of this article at https://doi.org/10.1007/s11684-021-0849-2 and is accessible for authorized users.

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