ABT-874 is a fully human IgG1, antibody isolated from a human antibody phage display library and optimized in a collaboration between Abbott Laboratories and Cambridge Antibody Technology Inc. Results of a phase 2 placebo-controlled, double-blind study in 79 patients with CD have been published (Mannon et al. 2004). In cohort 1, patients received ABT-874 1 mg/kg or 3 mg/kg or placebo subcutaneously. One injection was followed 4 weeks later by one injection per week for 6 weeks. In cohort 2, patients received ABT-874 1 mg/ kg or 3 mg/kg versus placebo subcutaneously weekly for 7 weeks. The primary end point was safety; secondary endpoints included clinical response (CDAI reduction > 100) and remission (CDAI <150). Patients were followed for 18 weeks. Patients receiving ABT-874 in cohort 1 did not have a significantly different response versus placebo. In cohort 2, patients receiving ABT-874 at a dose of 3 mg/kg after 7 weeks of uninterrupted therapy (end of dosing) achieved greater response rates than placebo (75% vs. 25%; p = 0.03). As expected, response diminished over time after the completion of dosing at 7 weeks, and the difference between the groups was no longer significant at the end of 18 weeks (69% vs. 25%; p = 0.08). Remission rates did not differ at the end of dosing or at the end of the 18-week observation period. Patients with mucosal biopsies showed a post-treatment improvement of mucosal histologic score. Additionally, these patients had decreased secretion of IFN-y, TNF, IL-6, and IL-17bystimulated T cells and decreased secretion of IL-12 and IL-23 by stimulated antigen-presenting cells, which were associated with clinical improvement in patients treated with ABT-874. With the exception of a higher rate of local reactions at the injection site among ABT-874 patients, adverse events were similar among the groups.
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