BioCentury
ARTICLE | Clinical News

TNF-Kinoid: Final Phase IIa data

December 3, 2012 8:00 AM UTC

Final data from the double-blind, international Phase II TNF-K-005 trial in 60 patients with moderate to severe CD who have failed >=1 anti-TNF therapy showed that 3 doses of 180 µg TNF-Kinoid produced an immune response in 65% of patients with active disease (CDAI score of >150 points) and no residual anti-TNF antibodies at baseline. Additionally, a fourth dose of TNF-Kinoid given at day 84 caused a rebound in antibody titers to a peak higher than that seen after the initial 3 doses. In patients who received placebo and crossed over to receive 3 doses of 180 µg TNF-Kinoid at day 84, 33% of patients who had an immune response and had no residual anti-TNF antibodies were in clinical remission 3 months later vs. 0% of patients who did not have an immune response. Data from patients with active disease and no residual anti-TNF antibodies from both treatment groups showed that TNF-Kinoid produced a clinical remission rate of 27% in patients who had an immune response vs. 12.5% of patients who did not have an immune response. ...