Health-related quality of life and treatment burden in patients with proliferative lupus nephritis treated with cyclophosphamide or azathioprine/ methylprednisolone in a randomized controlled trial

Abstract

Objective: To study prospectively the effect of treatment with cyclophosphamide pulses (CYC) or azathioprine with methylprednisolone (AZA), both for 24-month periods, on health-related quality of life (HRQOL) in patients with proliferative lupus nephritis (LN) in a randomized controlled trial. We expected better HRQOL during AZA treatment.

Methods: HRQOL and disease activity were measured at start and after 12 and 24 months. Generic questionnaires [patient's visual analog scale (VAS), Medical Outcomes Study Short Form-36 Health Survey (SF-36), Profile of Mood States] and a disease-specific measure [Systemic Lupus Erythematosus (SLE) Symptom Checklist] were used. Treatment burden was assessed at 24 months. Disease activity was measured with the SLE Disease Activity Index (SLEDAI) and physician's VAS.

Results: Complete questionnaire data were available from 47 of the 87 patients included in the trial. These patients were representative of the whole group, except that completers were more often Caucasian. HRQOL scores improved significantly during treatment, particularly during the first year, on both generic and disease-specific outcomes. No statistically significant differences were found in HRQOL between the CYC and AZA groups, except for the SF-36 mental component summary scale, which showed more favorable scores in the AZA group. The mean reported treatment burden at 24 months was significantly higher in the CYC group. HRQOL scores did not correlate with the SLEDAI and physician's VAS. The disease activity measures correlated positively with each other.

Conclusion: Treatment of patients with proliferative LN with immunosuppressive drugs and corticosteroids improves HRQOL, particularly in the first year. Due to the small groups studied, the absence of differences between AZA and CYC for most HRQOL scales should be interpreted cautiously: our data suggest that there may be no significant differences. Differences were a higher perceived treatment burden and worse mental HRQOL in the CYC group.