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One year study of efficacy and safety of infliximab in the treatment of patients with ocular and neurological Behçets disease refractory to standard immunosuppressive drugs
Rheumatology International, 10/30/09

Giardina AR et al. – The aim of the study was to assess the long-term efficacy and safety of Infliximab therapy in the treatment of patients with Behçet’s disease refractory to standard immunosuppressive agents.

Methods

21 patients that did not respond to corticosteroids and to at least 1 immunosuppressant (cyclosporin, methotrexate, azathioprine, cyclophosphamide) for presence of ocular and/or CNS involvement enrolled
18 patients completed study up to 54 weeks
Stable doses of prednisone (<10 mg/day) permitted, immunosuppressants discontinued at least 4 weeks prior baseline visit
Patients received three infusions of 5 mg/kg Infliximab (at weeks 0, 2 and 6) and infusions of 5 mg/kg Infliximab every 8 weeks
At each visit data on clinical symptoms, response to therapy and adverse events collected
Primary outcome of interest to assess clinical efficacy (total or partial recovery) of infliximab
Secondary end points were to evaluate quality of life and monitor safety of drug

Results

18 patients achieved total remission
2 patients achieved a partial remission and relapsed after 3 months from discontinuation of therapy
Infliximab well tolerated
Case of non-Hodgkin lymphoma observed within 6 months
Minor side effects were headache, dizziness, tachycardia that regressed spontaneously and did not entail interruption
Anti-nuclear antibodies not detected during period of observation

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