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This negative study showed that visilizumab at a dose of 5 µg/kg for two consecutive days was not effective for severe, corticosteroid-refractory ulcerative colitis and was, in fact, associated with increased cardiac and vascular adverse events.
Visilizumab is a monoclonal antibody therapy directed toward CD3, a surface T cell marker. Visilizumab was designed to reduce Fc receptor binding, thus diminishing cytokine-release syndrome, complement fixation, and activation of resting T cells, while at the same time selectively inducing apoptosis of active T cells. Open-label Phase I and IIA trials of visilizumab in severe, intravenous-corticosteroid-refractory ulcerative colitis (UC) showed evidence of efficacy, with a dose of 5 µg/kg administered on two consecutive days suggested to be an appropriate clinical dose [1,2].