Su2092 Clinical Risk Stratification Predicts Development of Endoscopic Recurrence After Crohn's Disease Surgery: Early Results From the POCER Study

G A A b st ra ct s ulcerations at ileocolonoscopy and a history of positive clinical response followed by secondary failure and/or intolerance to at least one TNFα antagonist. Patients randomized in the TNF-K group were receiving TNF-K at days 0, 7, 28, 84 and placebo at days 91 and 112. Patients randomized in the control group were receiving placebo at days 0, 7, 28, and TNFK at days 84, 91 and 112. TNF-K was injected intramuscularly at the dose of 180 mcg per injection. The primary end point was CDAI clinical remission (CDAI≤150) at week 8. Other efficacy end-points included mucosal healing at week 12 and evolution of calprotectin and C-reactive protein. Immune responses were evaluated through titration of anti-TNFα and anti-KLH antibodies. Results: All patients have been recruited. Fewmild or moderate transient local and systemic reactions have been recorded following immunizations. The only serious adverse event reported by the investigator as potentially related to the study drug was a deterioration of CD one month following administration of blinded treatment. There were no other safety concerns. Full analysis is ongoing. Conclusions: Active immunization with TNF-K in patients with Crohn's disease is safe. Full immunogenicity and clinical efficacy results will be presented.