© 2005 by BMJ Publishing Group Ltd & European League Against Rheumatism
CONCISE REPORT
Lupus erythematosus with leflunomide: induction or reactivation?
1 Departments of Immunology and Rheumatology and Hospices Civils de Lyon-bioMérieux Research Unit on Rheumatoid Arthritis, Hôpital Edouard Hérriot, Lyon, France
2 Department of Dermatology, Hôpital Edouard Hérriot, Lyon, France
Correspondence to:
Correspondence to:
Professor P Miossec
Clinical Immunology Unit, Departments of Immunology and Rheumatology, Hôpital Edouard Hérriot, 69437 Lyon Cedex 03, France; miossec{at}univ-lyon1.fr
Background: Leflunomide is a new oral disease modifying antirheumatic drug with a good safety profile.
Case report: The first case of lupus erythematosus in a 58 year old white woman after administration of leflunomide for primary Sjögrens syndrome is reported. The relationship between induced lupus and leflunomide was confirmed by the resolution of the skin rash when the drug was stopped and its recurrence when it was reintroduced following a dose-response effect.
Discussion: Peripheral blood cells from this patient, from 15 patients with rheumatoid arthritis, and from healthy controls were used in a bioassay, which suggested that leflunomide affected the Th1/Th2 balance. Such a side effect might be related, in part, to the anti-tumour necrosis factor
activity of leflunomide.
Abbreviations: ELISA, enzyme linked immunosorbent assay; ENA, extractable nuclear antigen; IFN
, interferon
; IL, interleukin; PBMC, peripheral blood mononuclear cells; RA, rheumatoid arthritis; TNF
, tumour necrosis factor 
Keywords: leflunomide; lupus; side effects; Th1/Th2 balance
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