RESEARCH - Adverse events and efficacy of TNF blockade with Remicade in patients with SLE

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Rheumatology Advance Access published online on September 11, 2009

Rheumatology, doi:10.1093/rheumatology/kep270

Adverse events and efficacy of TNF- blockade with infliximab in

patients with systemic lupus erythematosus: long-term follow-up of 13

patients

Aringer1,2, Frederic Houssiau3, Caroline Gordon4, Winfried B.

Graninger5, Reinhard E. Voll6, Eva Rath2, Guenter Steiner2 and f

S. Smolen2

1Department of Medicine III, Division of Rheumatology, University

Clinical Center Carl Gustav Carus at the Technical University of

Dresden, Dresden, Germany, 2Department of Rheumatology, Internal

Medicine III, Medical University of Vienna, Vienna, Austria,

3Department of Rheumatology, Cliniques Universitaires St Luc,

Université Catholique de Louvain, Bruxelles, Belgium, 4School of

Immunity and Infection, College of Medical and Dental Sciences,

University of Birmingham, Birmingham, UK, 5Department of Medicine,

Division of Rheumatology, Medical University of Graz, Graz, Austria

and 6Department of Internal Medicine III and Institute of Clinical

Immunology, University Hospital Erlangen, University of

Erlangen-Nuremberg, Erlangen, Germany.

Abstract

Objective. To follow-up on all available infliximab-treated SLE

patients for safety and long-term efficacy in order to extract

information that is useful for planning appropriate controlled trials

with infliximab in SLE.

Methods. We analysed charts of six patients treated in an open-label

safety trial and seven additional patients treated with infliximab on

a compassionate care basis for uncontrolled SLE organ inflammation.

Results. Out of nine patients with lupus nephritis, six had a

long-term response after four infusions of infliximab in combination

with AZA, lasting for up to 5 years. All five patients with lupus

arthritis responded, but this response did not last for >2 months

after the last infusion. One additional patient had a long-lasting

improvement in SLE interstitial lung disease. No symptoms suggestive

of infliximab-induced SLE flares occurred in any patients. Short-term

treatment appeared relatively safe, but one patient developed

deep-vein thrombosis and several infections. Under long-term therapy,

two patients had life-threatening or fatal events, namely CNS lymphoma

and Legionella pneumonia. Retreatment and treatment without

concomitant immunosuppression led to drug reactions.

Conclusions. Short-term therapy with four infusions of infliximab in

combination with AZA was relatively safe, and had remarkable long-term

efficacy for lupus nephritis and, potentially, also interstitial lung

disease. Long-term therapy with infliximab, however, was associated

with severe adverse events in two out of three SLE patients, which may

have been provoked by infliximab and/or by their long-standing

refractory SLE and previous therapies.

http://rheumatology.oxfordjournals.org/cgi/content/abstract/kep270v1?papetoc

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