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.

Lupus
|July 16, 2008
PubMed

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.