RESEARCH - SLE induced by anti-TNF-alpha therapy: a French national survey

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Arthritis Res Ther. 2005; 7(3): R545–R551.

Published online 2005 March 1. doi: 10.1186/ar1715. PMCID: PMC1174953

Copyright © 2005 De Bandt et al., licensee BioMed Central Ltd.

Systemic lupus erythematosus induced by anti-tumour necrosis factor

alpha therapy: a French national survey

Michel De Bandt,1 Sibilia,2 Xavier Le Loët,3 Sebastian Prouzeau,4

Bruno Fautrel,5 Christian Marcelli,6 Boucquillard,7 Louis

Siame,8 Xavier Mariette,9 and , the Club Rhumatismes et Inflammation

1Rheumatology Department, Hôpital Ballanger, Aulnay sous Bois, France

2CHU Hautepierre, Strasbourg, France

3Hôpital Bois-Guillaume, Rouen, France

4Hôpital de Saint Lo, Saint Lo, France

5Hôpital Pitié Salpétrière, Assistance Publique-Hôpitaux de Paris, Paris, France

6CHU côte de Nacre, Caen, France

7Hôpital de Saint Pierre de la Réunion, St Pierre France

8Polyclinique de Riaumont, Liévin, France

9Hôpital de Bicêtre, Assistance Publique-Hôpitaux de Paris, Le Kremlin

Bicêtre, France

Abstract

The development of drug-induced lupus remains a matter of concern in

patients treated with anti-tumour necrosis factor (TNF) alpha. The

incidence of such adverse effects is unknown. We undertook a

retrospective national study to analyse such patients.

Between June and October 2003, 866 rheumatology and internal medicine

practitioners from all French hospital centres prescribing anti-TNF in

rheumatic diseases registered on the website of the 'Club Rhumatismes

et Inflammation' were contacted by email to obtain the files of

patients with TNF-induced systemic lupus erythematosus. Twenty-two

cases were collected, revealing two aspects of these manifestations.

Ten patients (six patients receiving infliximab, four patients

receiving etanercept) only had anti-DNA antibodies and skin

manifestations one could classify as 'limited skin lupus' or

'toxidermia' in a context of autoimmunity, whereas 12 patients (nine

patients receiving infliximab, three patients receiving etanercept)

had more complete drug-induced lupus with systemic manifestations and

at least four American Congress of Rheumatology criteria. One patient

had central nervous system manifestations. No patients had lupus

nephritis. The signs of lupus occurred within a mean of 9 months

(range 3–16 months) in patients treated with infliximab and within a

mean of 4 months (range 2–5 months) in patients treated with

etanercept. In all cases after diagnosis was determined, anti-TNF was

stopped and specific treatment introduced in eight patients: two

patients received intravenous methylprednisolone, four patients

received oral steroids (15–35 mg/day), and two patients received

topical steroids. Lupus manifestations abated within a few weeks

(median 8 weeks, standard deviation 3–16) in all patients except one

with longer-lasting evolution (6 months). At that time, cautious

estimations (unpublished data from Schering Plough Inc. and Wyeth

Inc.) indicated that about 7700 patients had been exposed to

infliximab and 3000 to etanercept for inflammatory arthritides in

France. It thus appears that no drug was more implicated than the

other in lupus syndromes, whose incidence was 15/7700 = 0.19% with

infliximab and 7/3800 = 0.18% with etanercept.

Clinicians should be aware that lupus syndromes with systemic

manifestations may occur in patients under anti-TNF alpha treatment.

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