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

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Arthritis Res Ther. 2005;7(3):R545-51. Epub 2005 Mar 1.

Systemic lupus erythematosus induced by anti-tumour necrosis factor alpha

therapy: a French national survey.

Rheumatology Department, Hopital Ballanger, Aulnay sous Bois, France.

m.debandt@...

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 At that time, cautious estimations (unpublished data from Schering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.

PMID: 15899041

http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=pubmed & cmd=Retrieve & dopt=Abstra\

ctPlus & list_uids=15899041

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