Intravenous fontolizumab was evaluated in a phase 2 study at doses of 4 mg/kg and 10 mg/kg versus placebo in 133 patients with CD (Hommes et al. 2006). Forty-two patients received one dose and 91 patients received two doses on days 0 and 28. Fontolizumab failed to achieve the primary endpoint of response at Week 4. Efficacy was demonstrated, however, in a subgroup of patients with elevated baseline CRP concentration who received a second dose at Week 4. The safety and efficacy of fontolizumab also was evaluated in a dose-escalation study in which 45 patients with moderate to severe CD received single doses of 0.1, 1.0, and 4.0 mg/kg or placebo (Reinisch et al. 2006). By Day 29, patients with clinical response were randomized to receive three additional doses of one-half of their initial dose every 4 weeks. Safety was the primary endpoint; secondary endpoints included assessments of immunogenicity, clinical activity, and pharmacodynamic surrogates, such as CRP concentration. Fontolizumab was generally well tolerated in this study, although there were slightly more reports of chills, flulike syndrome, asthenia, nausea, and vomiting in the 1.0 and 4.0 mg/kg groups. Antibodies to fontolizumab were confirmed in one patient. Similar to the phase 2 trial, there were no differences in clinical activity parameters between active treatment and placebo. However, at Day 29, fon-tolizumab 4.0 mg/kg was associated with a decrease in median CD endoscopic index of severity (p = 0.02) and CRP concentration (p < 0.001) than placebo, suggesting biologic activity.
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