Safety and efficacy of tumor necrosis factor α blockade in systemic lupus erythematosus: An open‐label study

作者：Martin Aringer, Winfried B. Graninger, G Steiner, Josef S Smolen · 发表于：Arthritis & Rheumatism · 年份：2004 · DOI：10.1002/art.20576 · 被引用次数：342 · 研究领域：Systemic Lupus Erythematosus Research、Liver Diseases and Immunity、Rheumatoid Arthritis Research and Therapies

OBJECTIVE: To investigate the safety of therapeutic tumor necrosis factor alpha (TNFalpha) blockade in patients with systemic lupus erythematosus (SLE), in whom this proinflammatory cytokine is significantly increased and may be involved in the disease pathogenesis. METHODS: In an open-label study, 6 patients with moderately active SLE (4 with nephritis and 3 with arthritis refractory to other therapies) were given 4 300-mg doses of infliximab, a chimeric anti-TNFalpha antibody, in addition to immunosuppression with azathioprine or methotrexate. RESULTS: The only significant adverse events observed were urinary tract infection in 3 patients, 1 of which was accompanied by Escherichia coli bacteremia, and a prolonged febrile episode of putatively viral origin in 1 of them. These patients had similar infectious conditions in the past. In none of the patients was it necessary to terminate the treatment prematurely. Levels of antibodies to double-stranded DNA and cardiolipin increased in 4 patients each, but this was not associated with a decrease in serum complement levels, with vascular events, or with flares. In contrast, disease activity declined during therapy. All 3 patients with joint involvement experienced remission of arthritis, which relapsed 8-11 weeks after the last infliximab infusion. In the 4 patients with lupus nephritis, proteinuria decreased significantly within 1 week after initiation of therapy and was diminished by > or = 60% within 8 weeks, remaining at low ...