贝利尤单抗联合传统方案治疗儿童活动性狼疮性肾炎疗效分析

doi:10.12372/jcp.2024.23e0911

Abstract

Abstract:

Objective To investigate the efficacy of combining Belimumab with traditional therapy in treating active lupus nephritis (LN) in children during the early induction period, and to provide a novel diagnostic and therapeutic framework for the future treatment of LN in children. Method Clinical data were collected from 58 children with active LN newly diagnosed from January 2018 to August 2021. Participants were divided into observation group (32 cases) and control group (26 cases) based on the use of Belimumab in the induction stage. Serum biochemical markers(ALB, BUN, Cr, eGRF), immune markers (IgG, C3, C4, CD19⁺B count, anti-nuclear antibody), along with urinary microalbumin, urinary protein quantity at at 24h and SLEDAI-2K score were were assessed at baseline and after 4, 12, and 24 weeks of treatment. The compliance rate, recurrence rate and glucocorticoid dosage of the two groups were also followed up. Results No significant differences were found in renal pathological type and traditional treatment between the two groups (P>0.05), there were no significant differences in blood ALB, BUN, CR, C3 and C4 between the two groups(P>0.05). However, statistically significant differences were observed among all groups (P<0.05).The eGFR was higher in the observation group at 4 and 12 weeks, but no statistically significant difference was noted between the two groups (P>0.05). After 12 and 24 weeks of treatment,urinary microalbumin and urinary protein quantity at 24h were significantly reduced compared to the control group, with statistical significance (P<0.05); intergroup comparisons also showed significant differences (P<0.05). In the observation group at 24 weeks, the CD19⁺B cell count decreased from 653 (438-933.25) cells/μL to 45 (30.50-66.50) cells/μL, IgG decreased from 14.84 (12.03-17.64) g/L to 5.45 (5.11-5.79) g/L. The positive rate of anti-nuclear antibodies decreased from 100% to 46.87%, SLEDAI-2K score reached disease-free activity status. The complete remission rate (87.50%) and total efficiency (93.75%) in the observation group were significantly higher than those in the control group (65.38% and 84.62%, respectively), with statistical significance (P<0.05). The glucocorticoid dosage was reduced to 5 mg/d in 87.50% of children in the observation group after 24 weeks, compared to 76.92% in the control group, with statistically significant differences (P<0.05). After 2 years follow-up, the compliance rate in the observation group (93.75%) was significantly higher than that in the control group (61.54%), while the recurrence rate (6.25%) was lower than that of the control group (30.77%), with statistical significance (P<0.05). Conclusion The combination of Belimumab and traditional therapy is effective in treating active LN in children during the induction period. This approach alleviates proteinuria, improves disease activity in systemic lupus erythematosus (SLE), facilitates early glucocorticoid reduction, and enhances overall outcomes, demonstrating superior efficacy compared to traditional therapy alone.

Key words: active lupus nephritis, belimumb, standard treatment, child

PENG Qianqian, YANG Huandan, YUAN Tingting, QIU Shan, LI Yan, ZHOU Suqin, LU Qian. Efficacy of Belimumab combined with traditional regimen in the treatment of active lupus nephritis in children[J].Journal of Clinical Pediatrics, 2024, 42(11): 975-982.

Figures/Tables 5

References 34

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治疗方案	观察组（n=32）	对照组（n=26）	统计量	P
GC+HCQ+ACEI+MMF	9	7	2.14	0.677
Ⅲ型	3	4
Ⅲ+Ⅴ型	2	0
Ⅳ型	2	1
Ⅳ+Ⅴ型	0	0
Ⅴ型	2	2
GC+HCQ+ACEI+CTX	13	13	2.55	0.329
Ⅲ型	0	0
Ⅲ+Ⅴ型	2	4
Ⅳ型	10	6
Ⅳ+Ⅴ型	1	3
Ⅴ型	0	0
GC+HCQ+ACEI+FK506	8	3	1.94	0.709
Ⅲ型	0	0
Ⅲ+Ⅴ型	0	0
Ⅳ型	3	0
Ⅳ+Ⅴ型	3	1
Ⅴ型	2	2
GC+HCQ+ACEI+MMF +FK506	2	3	-	0.400^1）
Ⅲ型	0	0
Ⅲ+Ⅴ型	0	0
Ⅳ型	0	2
Ⅳ+Ⅴ型	2	1
Ⅴ型	0	0

指标	组别	基线	4周	12周	24周	F值	P
ALB/g·L^-1	观察组	27.17±6.28	33.54±4.94	40.42±3.97	43.72±3.49	6.11	<0.001
ALB/g·L^-1	对照组	29.25±5.77	34.68±5.13	40.74±3.87	43.42±2.98	2.82	0.004
t值		1.30	0.86	0.30	0.34
P		0.199	0.395	0.762	0.734
BUN/mmol/L^-1	观察组	8.38±3.83	6.52±1.61	4.96±0.78	4.24±0.77	3.46	<0.001
BUN/mmol/L^-1	对照组	7.95±3.15	6.18±1.24	4.99±0.66	4.32±0.60	3.55	<0.001
t值		0.46	0.88	0.18	0.44
P		0.647	0.384	0.861	0.661
Cr/μmol·L^-1	观察组	73.09±25.13	51.56±10.68	43.38±4.94	41.16±5.12	3.54	<0.001
Cr/μmol·L^-1	对照组	76.31±25.97	57.57±12.53	45.91±5.85	41.27±5.36	2.73	<0.001
t值		-0.48	1.97	1.79	0.08
P		0.635	0.054	0.079	0.9351
eGRF/mL·min^-1·1.73m^-2	观察组	109.51±39.18	143.07±29.60	164.23±17.38	173.70±18.26	1.02	0.533
eGRF/mL·min^-1·1.73m^-2	对照组	99.46±31.03	124.59±25.81	152.14±20.11	168.77±18.49	1.20	0.422
t值		1.07	2.50	2.46	1.02
P		0.292	0.015	0.017	0.313

指标	组别	基线	4周	12周	24周	统计量	P
C3[M(P₂₅~P₇₅)]/g·L^-1	观察组	0.39 （0.29~0.50）	0.75 （0.68~0.85）	1.03 （0.97~1.13）	1.23 （1.14~1.35）	H=105.79	<0.001
C3[M(P₂₅~P₇₅)]/g·L^-1	对照组	0.32 （0.25~0.46）	0.75 （0.71~0.80）	0.98 （0.91~1.21）	1.32 （1.23~1.34）	H=12.75	<0.001
Z值		1.16	0.19	0.44	0.98
P		0.247	0.851	0.661	0.328
C4[M(P₂₅~P₇₅)]/g·L^-1	观察组	0.05 （0.03~0.07）	0.13 （0.10~0.15）	0.20 （0.16~0.23）	0.25 （0.24~0.30）	H=100.89	<0.001
C4[M(P₂₅~P₇₅)]/g·L^-1	对照组	0.04 （0.03~0.05）	0.14 （0.24~0.30）	0.20 （0.16~0.23）	0.26 （0.24~0.30）	H=9.98	<0.001
Z值		1.93	0.47	-0.02	0.28
P		0.054	0.637	0.987	0.781
IgG[M(P₂₅~P₇₅)]/g·L^-1	观察组	14.84 （12.03~17.64）	8.81 （7.38~10.25）	6.53 （5.77~7.29）	5.45 （5.11~5.79）	H=60.13	<0.001
IgG[M(P₂₅~P₇₅)]/g·L^-1	对照组	14.92 （11.41~17.21）	8.46 （7.35~9.50）	6.36 （6.06~6.95）	5.25 （5.21~6.02）	H=12.84	<0.001
Z值		0.60	1.08	0.74	0.34
P		0.547	0.280	0.457	0.731
CD19⁺B[M(P₂₅~P₇₅)]/ 个·μL^-1	观察组	653 （438~933.25）	342 （295.25~439.50）	105 （99~122.25）	45 （30.50~66.50）	H=102.64	<0.001
CD19⁺B[M(P₂₅~P₇₅)]/ 个·μL^-1	对照组	543 （279.25~695.75）	345 （315~481.75）	181 （113.50~217.50）	156 （98.50~191.25）	H=4.70	<0.001
Z值		2.18	0.32	3.32	5.24
P		0.029	0.748	0.001	<0.001
抗ds-DNA抗体[n（%）]	观察组	32（100）	32（100）	25（78.13）¹⁾	15（46.87）²⁾	χ²=14.94	0.001
抗ds-DNA抗体[n（%）]	对照组	26（100）	26（100）	23（88.46）	20（76.92）	χ²=6.160	0.046
χ²值		7.55	7.55	4.31	3.66
P		<0.001	<0.001	<0.001	<0.001

指标	组别	基线	4周	12周	24周	H值	P
尿微量白蛋白/mg·d^-1	观察组	257 （84.01~402.75）	73.40 （35.31~103.52）	5.93 （2.42~15.66）	1.24 （0.98~2.65）	93.22	<0.001
尿微量白蛋白/mg·d^-1	对照组	191.60 （30.36~136.45）	66.03 30.36~136.46）	15.36 （3.98~45.64）	6.91 （1.36~20.83）	51.98	<0.001
Z值		-0.625	-0.023	-2.205	-3.120
P		0.532	0.981	0.027	0.002
24 h尿蛋白定量	观察组	2.39 （0.90~4.75）	0.86 （0.53~1.26）	0.21 （0.14~0.45）	0.12 （0.08~0.25）	90.55	<0.001
24 h尿蛋白定量	对照组	1.86 （0.67~3.50）	0.21 （0.14~0.45）	0.42 （0.17~0.74）	0.30 （0.13~0.36）	2.42	0.002
Z值		1.00	0.16	2.30	3.18
P		0.317	0.870	0.021	0.001

	基线	12周	24周	χ²值	P
观察组	32（100）	20（62.50）	28（87.50）	16.63	<0.001
对照组	26（100）	13（50.00）	20（76.92）	17.45	<0.001
χ²值	7.55	5.68	6.86
P	<0.001	<0.001	<0.001

Efficacy of Belimumab combined with traditional regimen in the treatment of active lupus nephritis in children

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