title: Efficacy of enteric-coated mycophenolate sodium in patients with resistant-type lupus nephritis: a prospective study.
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.
authors.affiliation: Division of Nephrology, Department of Medicine, Chulalongkorn University, Rama IV, Bangkok, Thailand.
authors.forename: O
authors.initials: O
authors.lastname: Traitanon
authors.forename: Y
authors.initials: Y
authors.lastname: Avihingsanon
authors.forename: V
authors.initials: V
authors.lastname: Kittikovit
authors.forename: N
authors.initials: N
authors.lastname: Townamchai
authors.forename: T
authors.initials: T
authors.lastname: Kanjanabuch
authors.forename: K
authors.initials: K
authors.lastname: Praditpornsilpa
authors.forename: J
authors.initials: J
authors.lastname: Wongchinasri
authors.forename: K
authors.initials: K
authors.lastname: Tungsanga
authors.forename: S
authors.initials: S
authors.lastname: Eiam-Ong
mesh_terms: D000328:Adult; D003520:Cyclophosphamide / Q000008:administration & dosage; D005260:Female; D006801:Humans; D007166:Immunosuppressive Agents / Q000008:administration & dosage* / Q000009:adverse effects; D007262:Infusions, Intravenous; D007668:Kidney / Q000473:pathology; D008181:Lupus Nephritis / Q000188:drug therapy* / Q000473:pathology; D008297:Male; D009173:Mycophenolic Acid / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D013608:Tablets, Enteric-Coated
chemical_list: D007166:Immunosuppressive Agents; D013608:Tablets, Enteric-Coated; D003520:Cyclophosphamide; D009173:Mycophenolic Acid