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Abstract Number: 1432

Safety and Efficacy of Etanercept in Systemic LUPUS Erythematosus

Josefina Cortes-Hernandez1, Natalia Egri1, Miquel Vilardell-Tarres1 and Josep Ordi-Ros2, 1Medicine Department. Systemic Autoimmune Diseases Unit, Hospital Universitari Vall dxHebron, Institut de Recerca (VHIR),, Barcelona, Spain, 2Internal Medicine, Vall De Hebron General Hospt, Barcelona, Spain

Meeting: 2012 ACR/ARHP Annual Meeting

Keywords: Etanercept and systemic lupus erythematosus (SLE)

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Session Information

Title: Systemic Lupus Erythematosus: Clinical Aspects

Session Type: Abstract Submissions (ACR)

Background/Purpose: TNF is a strong mediator of inflammation with a controversial role in SLE. Whereas few open-label studies have shown efficacy of anti-TNFα agents in patients with SLE arthritis and renal disease, many others have reported its potential risk of autoantibody formation. The aim of the study was to evaluate the efficacy and safety of etanercept in patients with moderate active SLE without renal involvement.

Methods: In this open-label study, 42 SLE patients with cardiopulmonary and/or articular involvement (10 with serositis, 6 with shrinking lung syndrome (SLS) and 35 with arthritis) refractory to other therapies were given etanercept (50 mg/weekly) in addition to conventional immunosuppression therapy. Clinical response was categorized in complete response when a complete resolution of the symptoms and/or SLEDAI score <4 was achieved; partial response when there was a 50% clinical improvement and no response when there was no clinical improvement.

 Results: Forty two lupus patients (34 female and 8 male, mean age 38.2 (18-60) were included and followed up prospectively for 24 months (3-6). Two of them withdrew from the study due to significant local reactions. Of the remaining patients, clinical improvement was observed in 38 of them (95%). Six patients had to be switched to adalimumab due to etanercept side-effects or lack of efficacy. Eight of the ten patients (90%) with pleuropericarditis achieved clinical remission in a mean period of 5.67±2.65 weeks. In four patients (80%) with SLS, FVC (%) rose from 43±12 to 58±16 (p<0.05) at the end of treatment. Thirty-five patients (92%) with joint involvement achieved remission of arthritis. Relapse was frequent after stopping medication and occurred 8-11 weeks after stopping treatment. The main adverse effects were local reactions (14%) and urinary tract infection (5%). Levels of ANA and/or anti-dsDNA rose in 6 patients (14%), but were not associated with lupus flare.

Conclusion: Anti-TNF agents are safe and efficacious in SLE and did not lead to an increase SLE activity. In view of their anti-inflammatory properties they can be a therapeutical alternative for refractory serositis and SLS.


Disclosure:

J. Cortes-Hernandez,
None;

N. Egri,
None;

M. Vilardell-Tarres,
None;

J. Ordi-Ros,
None.

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