Clinical trial of rituximab and leflunomide in the treatment of patients with systemic lupus erythematosus
10.13699/j.cnki.1001-6821.2024.11.001
- VernacularTitle:利妥昔单抗联合来氟米特治疗系统性红斑狼疮患者的临床研究
- Author:
Jia-Hui GUO
1
;
Jun-Jie ZOU
;
Yang-Yang WANG
;
Jin-Long ZHANG
;
Dan-Dan PANG
;
Xiao-Yan XU
Author Information
1. 东南大学附属中大医院药剂科,江苏南京 210003
- Keywords:
rituximab injection;
leflunomide tablet;
systemic lupus erythematosus;
clinical efficacy;
safety evaluation
- From:
The Chinese Journal of Clinical Pharmacology
2024;40(11):1547-1550
- CountryChina
- Language:Chinese
-
Abstract:
Objective To observe the clinical efficacy and safety of rituximab injection combined with leflunomide tablets in the treatment of patients with systemic lupus erythematosus(SLE).Methods The SLE patients were divided into control and treatment groups according to cohort method.The control group received leflunomide with 50 mg·d-1 after meal in the first 3 days of treatment and was adjusted to 20 mg·d-1 thereafter.On the basis of control group,the treatment group was combined with rituximab,375 mg·m-2 was given intravenously every 2 weeks in the first 3 times of treatment,and adjusted to once every 4 weeks from the 4th dose.Two groups were treated for 24 weeks.The clinical efficacy,systemic lupus erythematosus disease activity index(SLEDAI)scores,serological indicators,24-hour urinary protein and adverse drug reactions were compared between two groups.Results The treatment and control groups were enrolled 74 cases and 72 cases,respectively.After treatment,the total effective rates of treatment and control groups were 91.89％(68 cases/74 cases)and 79.17％(57 cases/72 cases)with significant difference(P＜0.05).After treatment,the SLEDAI scores of treatment and control groups were(7.21±1.67)and(9.03±1.35)points;the levels of anti-Smith/ribonucleoprotein antibodies were(81.43±18.25)and(59.38±14.61)U·mL-1;the levels of immunoglobulin G were(12.04±2.15)and(17.28±2.64)g·L-1;the levels of interleukin-10 were(33.39±7.13)and(39.87±9.02)pg·mL-1;24-hour urinary protein quantification were(1.46±0.32)and(2.67±0.54)g·24 h-1;all the differences were statistically significant(all P＜0.05).The drug adverse reactions of two groups were liver and kidney function injury and digestive tract reactions.The total incidences of drug adverse reactions in the treatment and control groups were 13.51％and 5.56％without significant difference(P＞0.05).Conclusion Rituximab injection combined with leflunomide tablets has a definitive clinical efficacy in the treatment of SLE patients,which can significantly reduce disease activity and inflammatory reactions,improve immune function,without increasing the incidence of drug adverse reactions.
