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Outcome of Leflunomide in the Treatment of Proliferative Lupus Nephritis Compared to Cyclophosphamide

Journal of Biosciences and Medicines 2021年第3期9卷 64-76页

作者： Shahida Mullah Muhammad Rafiqul Alam Shamim Ahmed Amanur Rasul Md. Faisal Anirban Kishor Singha A. K. M. Shahidur Rahman Diwakar Manandhar Asif Mahmud Bikram Bir Bajracharya S. M. Shamsuzzaman Rafi Nazrul Islam Md. Rezaul Alam Ferdous Jahan Department of Medicine Sarkari Karmachari Hospital Dhaka Bangladesh Department of Nephrology Bangabandhu Sheikh Mujib Medical University (BSMMU) Dhaka Bangladesh Department of Rheumatology Bangabandhu Sheikh Mujib Medical University (BSMMU) Dhaka Bangladesh Department of Nephrology Dhaka Medical College Hospital (DMCH) Dhaka Bangladesh Department of Nephrology Kurmitola General Hospital Dhaka Bangladesh Lecturer of Nephrology Kist Medical College and Teaching Hospital Kathmandu Nepal Clinical Fellow ST3+ Medicine and Specialties Worcestershire Royal Hospital Worcester UK goshairhat upazila health complex Shariatpur Bangladesh Department of Nephrology & Dialysis BIRDEM General Hospital Dhaka Bangladesh

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). Concl

关键词： Cyclophosphamide Leflunomide Lupus Nephritis (LN) Systemic Lupus Erythematosus (SLE)

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