The effect of tacrolimus combined with mycophenolate mofetil or cyclophosphamide on renal response in systemic lupus erythematosus patients

Abstract Objective This study aimed to determine the therapeutic effect of tacrolimus (TAC) and its combination with mycophenolate mofetil (MMF) or cyclophosphamide (CYC) on the complete response (CR) in patients with systemic lupus erythematosus (SLE). Methods A retrospective cohort study based on medical data was conducted among SLE patients taking at least one of TAC, MMF and CYC during 2010–2021. Odds ratio (OR) and 95% confidence interval (CI) were calculated and multiplicative interactions were estimated using logistic regression models. Results Among 793 SLE patients, 27.9% (221 cases) patients achieved CR after at least 3 months. TAC use was positively associated with CR with adjusted OR (95% CI) of 2.82(1.89, 4.22) in overall, as well as in subgroups of SLE patients with SLEDAI score > 12, moderate or severe urinary protein and comorbidities. The dose-response effect on CR was further observed at the dose of TAC more than 4 mg/d and more than 180 days, with adjusted OR (95% CI) of 5.65(2.35, 13.55), and 3.60(2.02, 6.41) respectively. Moreover, the combined effect of TAC with MMF or CYC was better than monotherapy with the significant multiplicative interaction, with adjusted OR (95% CI) of 2.43(1.20,4.92) and 3.14(1.49,6.64), respectively, and similar results were also observed for the combination of different doses of TAC with MMF or CYC. Conclusion TAC can effectively alleviate the condition of patients with SLE and may interact with MMF or CYC, suggesting that the combination therapy of TAC with MMF or CYC may produce greater benefits for patients with SLE. Trial registration: This is a purely observational study that does not require registration.