Methotrexate in patients with moderate systemic lupus erythematosus (exclusion of renal and central nervous system disease)

doi:10.1136/ard.56.6.382

Annals of the Rheumatic Diseases 1997;56:382-385; doi:10.1136/ard.56.6.382

Ann Rheum Dis 1997;56:382-385 ( June )

Concise reports

Methotrexate in patients with moderate systemic lupus erythematosus (exclusion of renal and central nervous system disease) S Gansauge,^b A Breitbart,^a N Rinaldi,^a M Schwarz-Eywill^a

^a Medizinische Klinik und Poliklinik V, Universität Heidelberg, Germany , ^b St Vincenz und Elisabeth Hospital, Mainz, Germany

Correspondence to: Dr S Gansauge, St Vincenz und Elisabeth Hospital, Abteilung Rheumatologie, An der Goldgrube 11, 55131 Mainz, Germany.

Accepted for publication 10 March 1997

OBJECTIVES $---$ Methotrexate (MTX) has been used in several autoimmune diseases. Apart from its use in rheumatoid arthritis, MTX has beenassessed in small studies in patients with vasculitis, uveitis,and inflammatory bowel disease. The aim of this study was to evaluatethe efficacy of MTX in a particular group of patients with systemiclupus erythematosus(SLE).
PATIENTS $---$ In an open prospective study 22 patients fulfilling the ACR criteria for SLE were included. Patients had one or more of thefollowing manifestations: active non-destructive polyarthritis,dermatitis, vasculitis of the skin, pleuritis. All patients hadbeen treated with corticosteroids for at least six months withoutachieving remission. Sixteen patients were taking antimalarialdrugs in addition to corticosteroids, which were stopped at thebeginning of the trial. Patients with renal and central nervousinvolvement were excluded from the study. All patients receivedMTX orally at a dose of 15 mg/week over six months. Corticosteroidswere continued. As additional medication only indomethacin upto 100 mg/day was permitted if used before the start of the study.The outcome was evaluated using the SLE disease activity index(SLEDAI).
RESULTS $---$ Disease activity was evaluated after six months of MTX treatment. All patients completed the study period. The SLEDAI decreasedsignificantly from mean (SD) 12.2 (3.99) to 4 (3.75) (p=0.001).The prednisolone dose was reduced from a mean (SD) of 17.4 (12.8)at the beginning to 8.8 (5.36) mg/day at the end point of thestudy (p=0.01). MTX was well tolerated. Four patients complainedof general malaise. Two patients had transient increases in liverenzymes. In no case did MTX have to bestopped.
CONCLUSIONS $---$ In an open prospective study methotrexate was used in SLE patients with particular clinical characteristics. MTX was shownto be effective in reducing disease activity and sparing the doseof corticosteroids. Further controlled studies arenecessary.

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