Comparative efficacy of tacrolimus-based induction therapy with and without mycophenolate mofetil in lupus nephritis: A target trial emulation study

Objectives To compare the efficacy of tacrolimus (TAC) plus glucocorticoids (GCs) with that of TAC plus mycophenolate mofetil (MMF) and GCs for the induction of remission in proliferative lupus nephritis (LN). Methods This multicentre cohort study, designed as a target trial emulation, included patients with biopsy-proven proliferative LN who received TAC-based induction therapy. Patients were classified into the TAC + GC and TAC + MMF + GC groups. The primary outcome was total renal response at 12 months, which was defined as a complete or partial renal response. To address baseline imbalances between the groups, inverse probability of treatment weighting (IPTW) was applied. Binary logistic regression was used to estimate the odds ratio (OR) for the renal response. Results In total, 115 patients (48 with TAC + GC and 67 with TAC + MMF + GC) were included in the study. A 12-month total renal response was achieved in 16 (33.3%) patients in the TAC + GC group and 40 (59.7%) patients in the TAC + MMF + GC group (p = .009). After IPTW adjustment, the TAC + MMF + GC group showed significantly higher 12-month total renal response (IPTW-adjusted OR 2.84 [1.31-6.35]). Adverse drug reactions occurred in 7 patients in the TAC + GC group and 11 patients in the TAC + MMF + GC group. Conclusions In patients with proliferative LN, TAC + MMF + GC therapy was associated with a significantly higher 12-month renal response than TAC + GC. These findings support TAC + MMF + GC as the preferred TAC-based induction regimen for proliferative LN.