P-177 Long-term Safety of Adalimumab in Pediatric Patients with Crohnʼs Disease

Abstract

Purpose: The safety profile of adalimumab (ADA) in children with moderately to severely active Crohn's disease (CD) enrolled in the clinical trial IMAgINE 1 up to week 52 has been reported previously.1 Cumulative safety data including the ongoing open-label extension (OLE) is presented in this report. Methods: Patients (pts) who completed IMAgINE 11 had the option to continue in the ongoing OLE. Treatment-emergent adverse events (AEs) were monitored regularly and by spontaneous reporting. Rates of AEs were assessed per 100 patient-years (PY) of exposure for any pt enrolled in the double-blind clinical trial IMAgINE 1 and followed through the 31 July 2011 cut-off or up to 70 days After the last dose of ADA. Subgroup analysis by prior infliximab (IFX) use was also performed. Results: 192 pediatric pts had received ADA for CD, totaling 304.1 PY of exposure. As of 31 Jul 2011, 29/192 (15%) pts had up to 3 years of exposure. The most common AE for all pts was injection site reaction; all were non-serious. The most common serious AE (SAE) was flare or worsening of CD. Rates of SAEs, infections and AEs leading to discontinuation were consistent with IMAGINE 1.1 Serious AEs were experienced by significantly more pts exposed to prior IFX than IFX-naive pts (Table). No malignancies, TB, demyelinating disease, or deaths were reported. Conclusion: Prolonged ADA treatment, up to 3 years, in children with moderately to severely active CD has a safety profile that is consistent with known ADA data1 and no new safety signals have been identified. (Table Presented).