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CECILE GROOTSCHOLTEN, FRANK J. SNOEK, MARC BIJL, HANS C. van HOUWELINGEN, RONALD H.W.M. DERKSEN, and JO H.M. BERDEN, for the Dutch Working Party on SLE

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. (First Release July 15 2007; J Rheumatol 2007;34:1699-707)

Key Indexing Terms:

SYSTEMIC LUPUS ERYTHEMATOSUS
LUPUS NEPHRITIS
QUALITY OF LIFE
QUESTIONNAIRE
HEALTH STATUS
DISEASE ACTIVITY

From the Division of Nephrology, Radboud University Nijmegen Medical Center, Nijmegen; Department of Medical Psychology, VU University Medical Center, Amsterdam; Division of Clinical Immunology, University Medical Center Groningen, Groningen; Department of Medical Statistics, Leiden University Medical Center, Leiden; and Department of Rheumatology and Clinical Immunology, University Medical Center Utrecht, Utrecht, The Netherlands.

Supported by the Dutch Kidney Foundation (C94.1363), the Dutch Arthritis Association (No. 735), and the Netherlands Organization for Scientific Research (Fellowship for Clinical Investigators, NWO No. 920-03-115).

C. Grootscholten, MD, PhD; J.H.M. Berden, MD, PhD, Division of Nephrology, Radboud University Nijmegen Medical Center; F.J. Snoek, PhD, Department of Medical Psychology, VU University Medical Center; M. Bijl, MD, PhD, Division of Clinical Immunology, University Medical Center Groningen; H.C. van Houwelingen, PhD, Department of Medical Statistics, Leiden University Medical Center; R.H.W.M. Derksen, MD, PhD, Department of Rheumatology and Clinical Immunology, University Medical Center Utrecht, for the Dutch Working Party on SLE.

Address reprint requests to Dr. J.H.M. Berden, Division of Nephrology (464), Radboud University Nijmegen Medical Center, PO Box 9101, 6500 HB Nijmegen, The Netherlands. E-mail: j.berden@nier.umcn.nl

Accepted for publication May 13, 2007.