Retrospective Comparative Study of Tacrolimus and Cyclophosphamide Treatment in Pediatric Lupus Nephritis

Summary

This retrospective study compared tacrolimus plus glucocorticoids versus cyclophosphamide in 112 pediatric lupus nephritis patients. Tacrolimus-based regimen showed higher remission rates, better renal and immune outcomes, and fewer adverse events, supporting its efficacy and safety in this population.

Abstract

Lupus nephritis (LN) is a kidney injury caused by systemic lupus erythematosus (SLE) and can lead to serious impairment of renal function. Glucocorticoid (GC) combined with cyclophosphamide (CTX) is currently a commonly used treatment for LN; however, it is associated with several limitations, including a high proportion of refractory cases, a high recurrence rate after remission, and a long treatment cycle. The purpose of this study was to evaluate the safety and efficacy of Tacrolimus (Tac) combined with GC in the treatment of lupus nephritis.

This retrospective cohort study included 112 pediatric LN patients at Inner Mongolia Autonomous Region People's Hospital (January 2022 to June 2025), divided into two groups (n = 56 each): Tac group [Tac + GC] and CTX group (CTX + GC), with a treatment duration of 6 months. Primary endpoints included post-treatment overall response rate, pre/post-treatment renal function, and disease activity scores. Secondary endpoints included immune-inflammatory markers, immune function parameters, anti-dsDNA antibody positivity rate (pre/post-treatment), and adverse reaction incidence.

Baseline characteristics showed no significant difference between the two groups (P > 0.05). Post-treatment, the Tac group had a significantly higher complete remission rate than the CTX group (P < 0.05). Both groups exhibited improved renal function, reduced immune-inflammatory markers, immunoglobulins, and anti-dsDNA positivity (P < 0.05), and increased complement C3 and C4 levels (P < 0.05). The Tac group showed more pronounced improvements and a lower overall adverse reaction incidence (P < 0.05). Tac combined with GC can improve renal function and immune-inflammatory status in children with lupus nephritis, with good safety.

Introduction

Childhood-onset lupus nephritis (CLN) constitutes a serious complication of pediatric systemic lupus erythematosus (SLE), characterized by renal involvement that may lead to chronic kidney disease and renal failure¹. The prevalence of renal involvement in children with Childhood Systemic Lupus Erythematosus (cSLE) is as high as 35%–60%¹. Compared to adult-onset Lupus Nephritis (LN), CLN typically presents with more severe manifestations and a poorer prognosis^2,3. The incidence of cSLE varies between 3.3 and 8.8 per 100,000 pediatric individuals, with higher numbers repo....

Protocol

Ethical approval was obtained from the Institutional Ethics Committee of Inner Mongolia Autonomous Region People's Hospital (approval No.202515810K) prior to data collection. All procedures complied with the National Measures for Ethical Review of Biomedical Research Involving Human Beings and the Declaration of Helsinki²⁶. Anonymized retrospective medical records were used, and all personal information was de-identified to maintain confidentiality.

Inclusion criteria
The inclusion criteria were age ≤ 12 years old; LN diagnosis by renal biopsy and pathological examination according to the Interna....

Results

Baseline characteristics of the study population
Baseline characteristics of the Tac group (n = 56) and CTX group (n = 56) are compared in Table 1. There was no significant difference in sex, age, age of onset, SLEDAI-2000 score, duration of disease, organ damage, clinical classification and pathological classification between the two groups (P > 0.05), indicating that the two groups had balanced baseline and good comparability.

Discussion

This study found that the Tac group’s complete remission rate of 69.6% and total remission rate of 94.6% were significantly higher than those in the CTX group, and this outcome is broadly comparable to findings from recent research in adult LN. Amudalapalli et al.³² confirmed in a randomized controlled trial published in 2025 that Tac as an induction therapy can achieve a complete remission rate of 65%-70% in adult LN, and the onset time is ~4–6 weeks shorter than that of traditional i.......

Materials

List of materials used in this article

Name	Company	Catalog Number	Comments
Automatic biochemical analyzer	Hitachi	7600-020
Automatic blood cell analyzer	Beckman coulter	DxH 800
Automatic urine analyzer	Roche	cobas 6800
Electrocardiograph	Mindray	iMEC 12
Electronic sphygmomanometer	OMRON	HEM-907
G*Power software	Heinrich-Heine-Universität Düsseldorf	Version 3.1	RRID:SCR_013726
Ifosfamide	Qilu Pharmaceutical (Hainan) Co., Ltd	86905847000094
Medical Dictionary for Regulatory Activities (MedDRA, version 26.0	RRID:SCR_003751
microscope	Olympus	CX23
Prednisone Acetate Tablets	Jichuan Pharmaceutical Group Co., Ltd	86901453001371
SPSS 25.0 statistical software	IBM	Version 25.0	RRID:SCR_002865
Tacrolimus Capsules	Sinopharm Chuankang Pharmaceutical Co., Ltd	86902014000215