Pediatric rheumatology

Comparative efficacy of intravenous cyclophosphamide, mycophenolate mofetil, and tacrolimus as induction therapy for lupus nephritis: A randomized controlled open-label trial

LupusPublished Randomised controlled trial

Authors' conclusion

TAC was non-inferior compared to IV CYC and MMF for LN as induction therapy, with a comparable safety profile during the study period.

Study context

Population
Children and adults aged ≥10 years with clinical or biopsy-proven lupus nephritis (LN)94% females
Participants
82 children
Comparison
IV CYC vs mycophenolate mofetil (MMF) vs tacrolimus (TAC) as induction therapy for LN
  • IV CYCn = 28reference
  • MMFn = 27
  • TACn = 27
Primary endpoint
Proportion achieving renal response (CR or partial (PR))
Follow-up
Week 24
Methodological detailsopen-label, non-inferiority, active-controlled, three-arm
  • Open-label
  • Non-inferiority
  • Active-controlled
  • Three-arm

Primary result

As reported in the abstract

Renal response (CR or PR) · 24 weeks

P = 0.58

Secondary outcomes

Events

OutcomeIV CYCTAC
Deaths due to serious infections31

Serum CXCL10 post-treatment

Reduced significantly post-treatment in all three groups
P < 0.001

Original publication

Comparative efficacy of intravenous cyclophosphamide, mycophenolate mofetil, and tacrolimus as induction therapy for lupus nephritis: A randomized controlled open-label trial. Lupus. Published 14 July 2025. doi:10.1177/09612033251361560

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