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Efficacy of enteric-coated mycophenolate sodium in patients with resistant-type lupus nephritis: a prospective study
O Traitanon1, Y Avihingsanon, V Kittikovit
1Division of Nephrology, Department of Medicine, Chulalongkorn University, Rama IV, Bangkok, Thailand.
Abstract:
The role of mycophenolate mofetil (MMF) is still controversial in the treatment of cyclophosphamide-resistant proliferative lupus nephritis (PLN). Enteric-coated mycophenolate sodium (EC-MPS) has less gastrointestinal adverse effects than MMF and is, therefore, increasingly utilised in organ transplantation. The aim of this study was to compare the efficacy and safety of EC-MPS versus an extended-course of intravenous cyclophosphamide (ED-IVCY) in resistant-type PLN. Thirty-one, biopsy-proven PLN, patients who failed to respond to an induction of IVCY were enrolled in a prospective, open-labelled, historically controlled study. Patients received 6 month of EC-MPS (720 mg b.i.d.) treatment. The patients in the ED-IVCY group, collected from a database, received a repeated 6-month course of monthly IVCY 0.5-1 g/m(2) of body surface area. Both groups received 0.5-1 mg/kg/day of prednisolone. Primary outcomes were partial or complete responses. A repeated kidney biopsy was performed to evaluate the histological response. No serious adverse events or patient deaths were observed during the study. Both groups had comparable baseline characteristics. At 6 months, the EC-MPS group had a comparable response rate with the ED-IVCY group. There were significantly less adverse events in the EC-MPS group. Repeated biopsies showed significant improvement in the EC-MPS group. EC-MPS provides salutary efficacy and safety in the treatment of resistant-type PLN and can be a suitably alternative treatment to ED-IVCY.
Insights
Enteric-coated mycophenolate sodium (EC-MPS) is effective and safe for treating cyclophosphamide-resistant proliferative lupus nephritis (PLN). This treatment showed comparable efficacy to extended intravenous cyclophosphamide but with fewer adverse events.
Area of Science:
- Nephrology
- Immunology
- Pharmacology
Background:
- The efficacy of mycophenolate mofetil (MMF) in cyclophosphamide-resistant proliferative lupus nephritis (PLN) remains debated.
- Enteric-coated mycophenolate sodium (EC-MPS) offers improved gastrointestinal tolerability compared to MMF, leading to its increased use in transplantation.
Purpose of the Study:
- To compare the efficacy and safety of EC-MPS against an extended-course of intravenous cyclophosphamide (ED-IVCY) in patients with resistant-type PLN.
- To evaluate histological and clinical responses in patients with refractory PLN treated with EC-MPS versus ED-IVCY.
Main Methods:
- A prospective, open-label, historically controlled study enrolled 31 patients with biopsy-proven PLN who were resistant to initial IVCY induction.
- Patients received 6 months of EC-MPS (720 mg b.i.d.) or a repeated 6-month course of monthly IVCY (0.5-1 g/m2), alongside prednisolone (0.5-1 mg/kg/day).
- Primary outcomes included partial or complete response rates, with repeated kidney biopsies assessing histological improvement.
Main Results:
- Both treatment groups exhibited comparable baseline characteristics.
- At 6 months, EC-MPS demonstrated a response rate similar to ED-IVCY.
- The EC-MPS group experienced significantly fewer adverse events compared to the ED-IVCY group.
- Repeated kidney biopsies revealed significant histological improvements in the EC-MPS cohort.
Conclusions:
- EC-MPS presents a safe and effective therapeutic option for patients with resistant-type proliferative lupus nephritis.
- EC-MPS serves as a viable alternative treatment to extended-course intravenous cyclophosphamide for refractory PLN, with a better safety profile.
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