Abstract: SA-PO249

Comparison of Tacrolimus and Mycophenolate Mofetil for Induction of Remission in Lupus Nephritis in Thailand: A Multicenter Randomized Controlled Trial

Session Information

Category: Glomerular

  • 1005 Clinical Glomerular Disorders

Authors

  • Ophascharoensuk, Vuddhidej, Chiang Mai University, Chiang Mai, Thailand
  • Sumethkul, Vasant, Ramathibodi Hospital, Bangkok, Thailand
  • Ingsathit, Atiporn, Faculty of Medicine Ramathibodi Hospital, Mahidol University, Bangkok, Thailand
  • Anutrakulchai, Sirirat, Khon Kaen University, Khon Kaen, Thailand
  • Avihingsanon, Yingyos, King Chulalongkorn Memorial hospital, Chulalongkorn University, Bangkok, Thailand
  • Chawanasuntorapoj, Ratana, Siriraj Hospital, Bangkok, Thailand
  • Sangthawan, Pornpen, Prince of Songkla University Hospital, Songkhla, Thailand
  • Kasitanon, Nuntana, Chiang Mai University, Chiang Mai, Thailand
  • Pichaiwong, Warangkana, RAJAVITHI HOSPITAL, Bangkok, Thailand
  • Ngamjanyaporn, Pintip, Ramathibodi Hospital, Bangkok, Thailand

Group or Team Name

  • warangkana
Background

We conducted a prospective multi-center, opened-label, parallel, randomized, controlled trial to compare tacrolimus (TAC) and mycophenolate mofetil (MMF) for induction of remission in lupus nephritis (LN).

Methods

Adult patients with biopsy-proven LN ISN/RPS Class III-V and active nephritis were receive prednisolone (0.7-1.0 mg/kg/day for 4 weeks of run in period and tapered) and randomly assigned to receive TAC (0.1 mg/kg/day) or MMF (1.5–2 g/day) for 6 months. All patients who had remission received AZA 1-2 mg/kg/day as standard treatment in the maintenance phase. The primary outcome was the probability of complete remission (CR) at 6 and 12 months and the secondary outcomes included CR or partial remission (PR), renal parameter (UPCR, serum creatinine, and GFR), adverse events (infection, leukopenia, GI symptoms, new onset DM/hyperglycemia, and alopecia) and health related quality of life scores (EQ5D).

Results

84 patients were randomized. One patient who was randomized to TAC group withdrew from the study immediately after randomization. Therefore, 42 patients were received MMF and 41 patients were received TAC.
Median times to complete remission were 6.1 months and 5.1 months in MMF and TAC groups (P= 0.82). The probability of CR was similar between 2 groups (HR=0.99; 95%CI 0.53 to 1.85; P=0.97). The reduction in UPCR were similar between 2 groups during induction period but there were significantly increasing UPCR in TAC group at 12 months (P=0.03). There were worsening serum creatinine and GFR in TAC group compared with MMF group during induction period but both serum creatinine and GFR were similar after maintenance therapy. Infection occurred more frequently in MMF group. Other adverse events and EQ5D scores were similar between 2 groups.

Conclusion

TAC is effective as MMF for induction therapy of active LN class III-IV. It have less infections than MMF but transiently increased serum creatinine and decreased GFR compared with MMF.
ClinicalTrials.gov ID: NCT01580865

Funding

  • Commercial Support