Abstract
Background: Lupus nephritis (LN) is one of the most common presentations of Systemic lupus erythematosus (SLE). Cyclophosphamide is one of the key immunosuppressive agents for the management of LN. Leflunomide is an isoxazole immunomodulatory agent has been shown to be safe, well tolerated and effective in SLE and LN. Objective: To evaluate the outcome of leflunomide in the treatment of proliferative lupus nephritis compared to cyclophosphamide. Method: This randomized clinical trial was held in Bangabandhu Sheikh Mujib Medical University (BSMMU), Dhaka, Bangladesh from July 2017 to August 2019. A total of 66 patients of proliferative lupus nephritis who need induction therapy were enrolled in this study. Leflunomide 100 mg/day for consecutive 3 days followed by 0.5 mg/kg/day in divided dose was given in experimental group (n = 32) and intravenous cyclophosphamide 0.5 gm/m2 of body surface area monthly pulse was given in control group (n = 34). All study patients have received prednisolone and hydroxychloroquine according to KDIGO guideline then followed up monthly for 6 months. Outcomes were measured at 6th month by renal function [S. Creatinine, 24 hours urinary total protein (24-hr UTP)], changes in SELENA-SLEDAI score, anti-ds DNA level, serum complement levels (serum C3 & C4), remission (complete/partial) and adverse drug responses. Result: In experimental group, remission occurred in 18 (56.3%) patients and no remission in 14 (43.7%) patients. In control group, remission occurred in 24 (70.6%) patients and no remission in 10 (29.4%) patients. Adverse effects in experimental group were: elevated ALT (6.3%), hypertension (12.5%), infection (6.3%) and amenorrhea (12.5%). In control group, adverse effects were mainly leucopenia (5.9%), infection (17.7%) and amenorrhea (29.4%). Intergroup analysis for treatment responses and adverse effects showed no significant difference (p > 0.05). Conclusion: Leflunomide combined with prednisolone is effective in the induction treatment of proliferative lupus nephritis in Bangladeshi patients in terms of response rate and adverse effects.
Highlights
Systemic lupus erythematosus (SLE) is an autoimmune disease that has potential to affect every organ in the body most commonly; the skin, kidneys, brain and joints
The current study aimed to evaluate the outcome of leflunomide in the treatment of lupus nephritis compared to cyclophosphamide
The current study revealed that, the percentage of amenorrhea was higher in cyclophosphamide group compared to that of leflunomide group; similar finding was observed in related previous studies [19] [27]
Summary
Systemic lupus erythematosus (SLE) is an autoimmune disease that has potential to affect every organ in the body most commonly; the skin, kidneys, brain and joints. That is, lupus nephritis (LN), accounts for the most morbidity and mortality in SLE [1]. Lupus nephritis (LN) is one of the most common presentations of Systemic lupus erythematosus (SLE). Objective: To evaluate the outcome of leflunomide in the treatment of proliferative lupus nephritis compared to cyclophosphamide. A total of 66 patients of proliferative lupus nephritis who need induction therapy were enrolled in this study. Leflunomide 100 mg/day for consecutive 3 days followed by 0.5 mg/kg/day in divided dose was given in experimental group (n = 32) and intravenous cyclophosphamide 0.5 gm/m2 of body surface area monthly pulse was given in control group (n = 34). Creatinine, 24 hours urinary total protein (24-hr UTP)], changes in SELENA-SLEDAI
Sign-in/Register to view highlights & summary Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a callDisclaimer: All third-party content on this website/platform is and will remain the property of their respective owners and is provided on "as is" basis without any warranties, express or implied. Use of third-party content does not indicate any affiliation, sponsorship with or endorsement by them. Any references to third-party content is to identify the corresponding services and shall be considered fair use under The CopyrightLaw.
