Background For decades, high-dose intravenous cyclophosphamide (ivCY) given for 24-30 months was regarded standard therapy for systemic lupus erythematosus (SLE) patients with proliferative lupus nephritis (LN). Previously, we showed that induction therapy with short-term (5 months) high-dose ivCY followed by mycophenolate mofetil (MMF) is as effective as long-term (24 months) high-dose ivCY in preventing renal relapses, end-stage renal disease, and mortality.(1)
Objectives The aim of the present analysis was to evaluate the effect of induction therapy with short-term high-dose ivCY followed by MMF on health-related quality of life (HRQoL).
Methods Between January 2003 and November 2006, 71 patients with biopsy-proven proliferative LN were included in the second Dutch LN Study. All patients were treated with ivCY (750 mg/m2, 6 pulses in 5 months) plus oral prednisone (OP; initially 1 mg/kg/day), followed by MMF (2000 mg/day) plus OP (10 mg/day) for 18 months, and then AZA (2 mg/kg/day) plus OP (10 mg/day) (CY/MMF group). HRQoL was assessed yearly with the Short Form-36 Health Survey (SF-36) and the SLE Symptom Checklist (SSC). Data were available for 62 of the 71 (87%) patients, with a median follow-up of 36 months (range 0-49). Results of the first 2 years were compared to the first Dutch LN Study, in which patients were treated with high dose ivCY (750 mg/m2, 13 pulses in 2 years) plus OP (initially 1 mg/kg/day) (CY group; n=50) or AZA (2 mg/kg/day) combined with iv methylprednisolone (3x3 pulses of 1000 mg) and OP (initially 20 mg/day) (AZA/MP group; n=37).(2) Generalized estimating equations (GEE) was used to analyze HRQoL over time within and between treatment groups.
Results Mean age of the 62 patients was 37.0 years (SD±11.4), 76% were female, and median time since diagnosis of SLE was 2 months (range: 0-16 years). The number of complaints and total distress level according to the SSC improved significantly during treatment. Fatigue (92%), painful joints (78%), and chubby cheeks/face (75%) were the most frequently reported complaints at baseline. The percentage of patients which reported to be fatigued decreased only slightly over time (85% after 4 years of treatment), while painful joints and chubby cheeks/face occurred less frequently during treatment (58% and 46% after 4 years, p<0.01). Six of the 8 domains of the SF-36 (physical functioning, role-physical, bodily pain, social functioning, role-emotional, and mental health) as well as the physical component summary improved significantly over time. No overall significant effect of treatment was found on vitality (p=0.068), general health (p=0.248), or the mental component summary (p=0.099). The course of HRQoL parameters during the first 2 years was comparable between the CY/MMF group and the CY and AZA/MP groups.
Conclusions This open-label study shows that induction therapy with short-term high-dose ivCY followed by MMF improves both general and disease-specific HRQoL in patients with proliferative LN.
Arends S, et al. Ann Rheum Dis. 2012;71(Suppl3):540.
Grootscholten C, et al. J. Rheumatol. 2007;34:1699-1707.
Disclosure of Interest None Declared