A multidrug, multitarget regimen proves superior to intravenous cyclophosphamide (IVCY) as induction therapy for lupus nephritis (LN), according to a randomized, controlled trial being published in Annals of Internal Medicine.
LN is the inflammation of the kidney caused by systemic lupus erythematosus. Treatment is challenging and usually consists of an initial induction phase to achieve rapid remission, followed by long-term maintenance. Complete remission with current induction therapy regimens remains low. Therefore, more effective induction regimens are needed. Researchers sought to assess the efficacy and safety of a multitarget therapy consisting of tacrolimus, mycophenolate mofetil, and steroid compared with IVCY and steroid as induction therapy for patients with LN. Three hundrend sixty-eight patients between the ages of 18 and 65 with LN were randomly assigned to one of two treatment groups. All participants received intravenous methylprednisolone pulse therapy for three days, followed by a dose of oral prednisone (0.6 mg/kg per day) each morning for four weeks. The dose of prednisone was tapered by 5 mg/d every day for two weeks, and then by 2.5 mg/d every two weeks.
The maintenance dose of prednisone was 10 mg/d. After the initial treatment, the multitarget group received mycophenolate mofetil (0.5 g) and tacrolimus (2 mg) each two times per day. The IVCY group received cyclophosphamide at a dose of 0.75 g/m2 body surface area, and then adjusted the dose to 0.5 to 1.0 g/m2 body surface area every four weeks for six doses. The patients were evaluated at two and four weeks, and then every four weeks until 24 weeks for changes in levels of proteinuria and serum albumin, and drug-related adverse effects. Both groups had high adherence rates. Patients in the multitarget group had greater changes in urine protein and serum albumin and at week 24, approximately 84 percent of patients were in partial or complete remission compared to 63 percent of patients in the IVCY group. The authors suggest that the multitarget regimen should be considered as an alternative to conventional therapies for LN.