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

Authors

Alekhya Amudalapalli, Rasmi Ranjan Sahoo, Ashlesha Shukla, Abhichandra Maddineni, Sandeep Nagar, Roshani Sridhar, Sudhish Gadde, Harish Buvanahalli Venkatshappa, Sumanth Madan, Gargi Sasmal, Pradeepta Sekhar Patro

Published in

Lupus. Pages 9612033251361560. Jul 14, 2025. Epub Jul 14, 2025.

Abstract

ObjectiveTo compare the efficacy of cyclophosphamide (IV CYC), mycophenolate mofetil (MMF), and tacrolimus (TAC), as induction treatment for lupus nephritis (LN).MethodsThis randomized, open-label, non-inferiority, active-controlled three-arm study included children and adult patients aged ≥10 years with clinical or biopsy-proven LN over a period of 1 year. Patients were randomized in a 1:1:1 ratio to receive IV CYC (0.5-0.75 g/m² monthly for 6 doses), MMF (2-3 g/day), or TAC (0.08-1 mg/kg/day). The primary outcome was the proportion of patients achieving renal response [complete (CR) or partial (PR)] at week 24 and secondary outcomes included the proportion of CR, PR, change in complements, anti-dsDNA antibody, and 24-hour urine protein levels, SLEDAI-2K and renal-SLEDAI scores from baseline to week 24. Serum CXCL10 was assessed at baseline and follow-up. Intention-to-treat analysis was performed.Results82 patients (94% females; median age 27.5 years) were randomized to receive IV CYC (28), MMF (27), and TAC (27). At 24 weeks, the renal response rates were 53.5%, 66.6%, and 62.9% in IV CYC, MMF, and, TAC groups, respectively. The lower limit of the confidence interval for the difference in renal response at 24 weeks between treatment groups was less than 20% (non-inferiority margin) (p = .58). Serum CXCL10 reduced significantly post-treatment in all three groups (p < .001). Three patients in the IV CYC group and one patient in TAC group died due to serious infections.ConclusionTAC was non-inferior compared to IV CYC and MMF for LN as induction therapy, with a comparable safety profile during the study period.

PMID:
40653982
Bibliographic data and abstract were imported from PubMed on 14 Jul 2025.

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