Efficacy and safety of multi-target therapy using a combination of tacrolimus, mycophenolate mofetil and a steroid in patients with active lupus nephritis

Abstract

Objectives. To examine the efficacy and safety of multi-target therapy using tacrolimus (TAC), mycophenolate mofetil (MMF) and a steroid as initial treatment for active lupus nephritis (LN).

Methods. We conducted a retrospective analysis of the data of 16 consecutive patients who received the multi-target therapy for active Classes III–V LN at our department. We also compared the outcomes of the multi-target therapy with those of TAC therapy (TAC + steroid), a study of which we had conducted previously in 13 patients with active LN (TAC group).

Results. All the patients treated with multi-target therapy achieved complete remission (CR) (mean, 4.6 ± 3.8 months; range, 1–15 months). The clinical profiles of the patients of the multi-target group were similar to those of the TAC group at baseline, except for a significantly higher level of proteinuria (4.6 ± 2.8 vs. 2.5 ± 2.1 g/gCr, p = 0.033) in the former. The CR rate at 6 months was significantly higher in the multi-target group as compared with that in the TAC group (81% vs. 38%, p = 0.018). Two cases of serious adverse events were associated with cytomegalovirus infection in the multi-target group, namely gastric ulcer and pancytopenia, both of which were successfully treated by antiviral therapy.

Conclusions. Multi-target therapy was effective as initial treatment for active LN, with CR achieved early and in a high percentage of patients. Although this therapy was generally well tolerated, it is important to bear in mind the associated risk of cytomegalovirus infection.

Keywords:

• Immunosuppressive therapy
• Multi-target therapy
• Mycophenolate mofetil
• Lupus nephritis
• Systemic lupus erythematosus
• Tacrolimus

Funding

This research received no specific grant from any funding agency in the public, commercial or not-for-profit sectors.

Conflicts of interest

H Ikeuchi has received research grants from Chugai Pharmaceutical, Co., Ltd. K Hiromura has received honoraria for lectures and research grants from Astellas Pharma Inc. Y Nojima has received honoraria for lectures and research grants from Astellas Pharma Inc and research grants from Chugai Pharmaceutical, Co., Ltd. All other authors have declared no conflicts of interest.