Mizoribine or Cyclophosphamide for Lupus Nephritis: A Randomized Clinical Trial

Dong, Z; Luo, P; Sun, S; Ni, Z; He, Y; Huang, X; Liu, Z; Wu, Z; Zhang, X; Liao, Y; Zhao, J; Lin, H; Zhang, X; Fu, R; Ding, G; Xu, Y; Wang, L; Xiao, Y; Shi, S; Zuo, X; Li, Z; Qiao, L; Wang, R; Li, W; Wan, J; Li, Y; Guan, T; Deng, X; Wu, X; Zheng, H; Chen, J; He, L; Yamaguchi, S; Wang, H; Cai, GY; Zhang, L; Chen, X

doi:10.1001/jamanetworkopen.2025.0648

Lupus & antiphospholipid syndrome

Mizoribine or Cyclophosphamide for Lupus Nephritis: A Randomized Clinical Trial

JAMA Netw OpenPublished 3 Mar 2025Randomised controlled trial

Primary result · Total remission rateResultRelative risk ratio 0.861 95% CI 0.729–1.016

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Authors' conclusion

This randomized clinical trial shows that compared with intravenous cyclophosphamide, oral mizoribine was noninferior and well tolerated when used with glucocorticoid for induction therapy of active lupus nephritis.

Study context

Population: Chinese patients aged 18 to 70 years with class III, III+V, IV, IV+V or V LN, 24-hour urinary protein ≥1.0 g and SLE disease activity index ≥8; 40 centres in China243 treated
Participants: 250 patients

Comparison: Oral mizoribine vs IV cyclophosphamide as induction therapy, plus oral GC
Mizoribinen = 123
Cyclophosphamiden = 120reference
Primary endpoint: Total remission rate (complete plus partial remission rate) (prespecified)
Follow-up: 52 weeks

Methodological detailsprospective, multicentre, parallel-group, open-label, phase 3, non-inferiority, First patient enrolled November 29, 2014; study finished March 14, 2019; follow-up 52 weeks

Prospective
Multicentre
Parallel-group
Open-label
Phase 3
Non-inferiority
First patient enrolled November 29, 2014; study finished March 14, 2019; follow-up 52 weeks

Primary result

Total remission rate

Relative risk ratio

0.861

95% CI 0.729–1.016

Events by treatment group

Mizoribine66.1%76

Cyclophosphamide76.8%86

Mizoribinevs Cyclophosphamide

relative risk ratio 0.861 (95% CI 0.729–1.016)

As reported in the abstract

Further findings

Changes in other immune parameters and kidney function

Generally similar between the groups

Safety

Any treatment-related treatment-emergent adverse events

Mizoribine80.5%

Cyclophosphamide78.7%

Upper respiratory tract infection (most frequent adverse event)

Mizoribine33.3%

Cyclophosphamide30.3%

Any treatment-related treatment-emergent adverse events: denominators 123 and 122 patients

Reference

Authors: Dong Z, Luo P, Sun S, Ni Z, He Y, Huang X, et al.
All 37 authors
Dong Z, Luo P, Sun S, Ni Z, He Y, Huang X, Liu Z, Wu Z, Zhang X, Liao Y, Zhao J, Lin H, Zhang X, Fu R, Ding G, Xu Y, Wang L, Xiao Y, Shi S, Zuo X, Li Z, Qiao L, Wang R, Li W, Wan J, Li Y, Guan T, Deng X, Wu X, Zheng H, Chen J, He L, Yamaguchi S, Wang H, Cai GY, Zhang L, Chen X
Journal: JAMA Network Open
Published: 3 Mar 2025
DOI: 10.1001/jamanetworkopen.2025.0648
PubMed: 40085084
Registration: NCT02256150

Topic: Lupus & antiphospholipid syndrome

Intervention details

Mizoribine: oral mizoribine 50 mg 3 times a day for 52 weeks plus oral GC
Cyclophosphamide: 6 IV doses at 0.5-1.0 g/m² body surface area (max 1.0 g/d) for 52 weeks plus oral GC

Key notes

Lower limit of 2-sided 95% CI greater than non-inferiority margin of 0.726
Non-inferiority margin 0.726; mizoribine noninferior to cyclophosphamide

More notes

Denominators 115 and 112 patients

Original publication

Mizoribine or Cyclophosphamide for Lupus Nephritis: A Randomized Clinical Trial. JAMA Netw Open. Published 3 March 2025. doi:10.1001/jamanetworkopen.2025.0648

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