Objective: To assess the effectiveness and safety of a protocol using medium doses of prednisone to treat lupus nephritis.
Methods: Patients receiving the 'Cruces-protocol cohort' (CPC) were paired 1:2 with patients from the 'historic cohort' (HC). The CPC received medium doses of prednisone combined with methyl-prednisolone pulses, hydroxychloroquine and immunosuppressive drugs, usually cyclophosphamide. The HC received cyclophosphamide and high-dose prednisone. Partial and complete remission rates and glucocorticoid-related toxicity were assessed.
Results: 15 CPC and 30 HC patients were analysed. The mean (SD) initial dose of prednisone was 22 (8) mg/d in the CPC vs. 49 (19) mg/d in the HC (p<0.001). The 6-month mean (SD) cumulative dose of prednisone was 1.7 (0.5) g (average daily dose 9mg) vs. 4.5 (2.1) g (average daily dose 25mg), respectively (p<0.001). The median cumulative dose of cyclophosphamide at six months was 3 (0-4.5) g in the CPC vs. 5 (0-16.8) in the HC (p<0.001). 15/15 (100%) vs. 10/30 (33%) patients were treated with hydroxychloroquine (p<0.001). At six months, 12/15 (80%) patients in the CPC achieved partial or complete remission vs. 14/30 (47%) in the HC (p=0.015). At 12months, 13/15 (87%) vs. 19/30 (63%) patients, respectively, were in complete or partial remission (p=0.055). Toxicity attributable to glucocorticoids was observed in 1/15 (7%) vs. 20/30 (67%) patients, respectively (p<0.0001).
Conclusion: A combination of medium-dose prednisone, methylprednisolone pulses, cyclophosphamide and hydroxychloroquine is at least as effective in achieving remission of lupus nephritis as regimes containing high-dose prednisone and causes less toxicity.
Keywords: Adverse effects; Glucocorticoids; Hydroxychloroquine; Osteonecrosis; Osteoporosis; Systemic lupus erythematosus.