We have conducted a series of clinical investigations involving patients with systemic lupus erythematosus - a chronic, relapsing and remitting disorder characterized by immune-mediated inflammation. The current studies have mainly focused on patients with lupus glomerulonephritis in an attempt to assess practical issues related to therapy with the alkylating agent cyclophosphamide and, in particular, to investigate new approaches to disease management. A feasibility study has demonstrated that outpatient therapy with bolus oral cyclophosphamide is safe and effective and an improved regimen for minimizing cyclophosphamide-induced nausea has been studied. A small pilot study of a murine monoclonal anti-CD5 ricin A chain immunoconjugate in 6 patients documented a chronic reduction in peripheral T cell populations with evidence of clinical improvement in two patients with lupus nephritis.
