The aim of the study was to assess the long-term eYcacy and safety of InXiximab therapy in the treatment of patients with Behçet's disease refractory to standard immunosuppressive agents. Twenty-one patients that did not respond to corticosteroids and to at least one immunosuppressant (cyclosporin, methotrexate, azathioprine, cyclophosphamide) for the presence of ocular and/or CNS involvement were enrolled. Eighteen patients completed the study up to 54 weeks. Stable doses of prednisone (<10 mg/day) were permitted, immunosuppressants were discontinued at least 4 weeks prior baseline visit. The patients received three infusions of 5 mg/kg InXiximab (at weeks 0, 2 and 6) and then infusions of 5 mg/kg InXiximab every 8 weeks. At each visit data on clinical symptoms, response to therapy and adverse events were collected. The primary outcome of interest was to assess the clinical eYcacy (total or partial recovery) of inXiximab. Secondary end points were to evaluate quality of life and to monitor the safety of the drug. Eighteen patients achieved a total remission. Two patients achieved a partial remission and relapsed after 3 months from discontinuation of therapy. InXiximab was well tolerated throughout the study. A case of non-Hodgkin lymphoma was observed within 6 months.Minor side eVects were headache, dizziness, tachycardia that regressed spontaneously and did not entail interruption. Anti-nuclear antibodies were not detected during the period of observation.
Behçet's disease is a multisystem disorder that is characterized by oral and genital ulcers, and mucocutaneous, ocular, joint, vascular and central nervous system involvement. It is particularly frequent in countries along the Silk Route, from the Mediterranean area to Japan, and is strongly associated with HLA-B51 [1].Various micro-organisms such as streptococci and herpes simplex virus have been implicated in the pathogenesis of Behçet's disease. There is also evidence of immunological dysregulation, including neutrophil hyperfunction, autoimmune manifestations, and several phenotypic and functional lymphocyte abnormalities, possibly resulting from complex interactions of genetic and environmental factors DMAPP = dimethylallyl pyrophosphate; EF = expansion factor; FACS = fluorescence activated cell sorting; FITC = fluorescein isothiocyanate; IL = interleukin; mAb = monoclonal antibody; PBMC = peripheral blood mononuclear cell; PBS = phosphate buffered saline; PE = phycoerythrinlabelled; TCR = T-cell receptor; TNF = tumour necrosis factor.
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