S164 Poster presentations

P385Relationship between adalimumab concentration andefficacy for the induction of clinical remission in pediatricpatients with moderate to severe Crohn’s disease

R. Pradhan1, S. Sharma1, R. Thakkar1, A. Robinson1, J. Hyams2,J. Rosh3, F.M. Ruemmele4, W. Awni1 *. 1Abbott Laboratories,United States, 2Connecticut Children’s Med Ctr, United States,3NJ Medical School, United States, 4Hopital Necker-EnfantsMalades, France

Background: The purpose of this analysis was to characterizethe relationship of adalimumab concentration (conc) toremission or response following an induction dose in pediatricpatients (pts) with moderate to severe Crohn’s disease (CD).Methods: Trough serum adalimumab conc and efficacy(response/remission) data were obtained at multiple timepoints from the 4-week (wk) open-label induction phase(160/80 mg or 80/40 mg at wk 0/2 based on body weight cut-off of 40 kg) of a 52-wk study. Pediatric Crohn’s Disease ActivityIndex (PCDAI) was used to quantify clinical response (PCDAIreduction of �15 from baseline) and remission (PCDAI �10) atwk 4 in all patients. The trial’s primary endpoint was PCDAIremission at Wk 26.Results: At wk 4, the mean±SD (median) serum adalimumabconc (mg/mL) in remitters, 14.5±5.79 (15.2), was slightlyhigher (p = 0.280) than in non-remitters, 13.6±7.20 (13.1). Wk4 response and remission rates were higher in pts with serumadalimumab conc above median (Figure 1). A clear exposure-response/remission relationship was evident.

Figure 1. Remission and response by adalimumab conc at Wk 4.

Additional analyses were conducted to evaluate the effect ofbody weight on the exposure-remission relationship (Figure 2).A consistent exposure remission relationship was observed infirst and third weight tertiles.

Figure 2. Remission by weight tertiles, adalimumab conc at Wk 4.

Sex, Baseline PCDAI, plasma CRP levels and prior anti-TNFtreatment did not have a statistically significant effect on theexposure-response/remission relationship.Conclusions: In general, increased exposure of adalimumabwas associated with greater levels of efficacy in pediatricCD. Additional analyses are required to further quantify these

relationships with respect to trough concentration cut-offvalues and efficacy outcomes.

P386Refractory inflammatory bowel disease, treated withanti-TNF agents in patients with hepatitis C

I. Gubonina1 *, A. Pershko1, A. Dragun2. 1Military MedicalAcademy, 2nd Therapy Dpt, St-Petersburg, RussianFederation, 2International Medical Centre “Sogaz”,Out-patient department, St-Petersburg, Russian Federation

Background: Data on the frequency of liver dysfunction inpatients with inflammatory bowel disease (IBD) treated withAnti-TNF agents and infected with hepatitis C virus arelimited.Methods: Ten patients (four men, six women and aged 28 45)with refractory IBD and HCV infection were included in ourdepartment between 2005 and 2012. Clinical records werereviewed for the type and duration of therapy used, liverfunction tests and viral markers before, during and aftertreatment.Results: All patients had refractory IBD and HCV markers(HCV-RNA positive). Six patients suffered from Crohn’s diseaseand four patients from ulcerative colitis. All patients weretreated with infliximab 5 mg/kg every 8 weeks after undergoinginduction at weeks 0, 2 and 6. The duration of infliximabtherapy was from 8 to 24 months. 9 of 10 patientsreceived combination of infliximab and immunosuppressant(azathyoprine 2.5 mg/kg/day). All patients treated withinfliximab experienced sustained improvement of their IBDsymptoms, 3 patients reached clinical remission.Liver dysfunction was observed in 2 of 10 HCV-RNA positivepatients (20%), both of them received combined infliximaband azathyoprine therapy. None of them progressed withhepatic failure. During anti-TNF therapy, none of the patientsexperienced HCV reactivation.Conclusions: Anti-TNF therapy appears to be safe and effectivefor treating refractory IBD in patients with HCV infection.

P387Reduced length of hospitalisation and treatment costswith infliximab versus ciclosporin in patients with severeulcerative colitisM. Lowenberg1 *, N. Duijvis1, C. Ponsioen1, W. Bemelman2,G. van den Brink1, P. Fockens1, G. D’Haens1. 1AMC,Gastroenterology, Amsterdam, Netherlands, 2AMC, Surgery,Amsterdam, Netherlands

Background: Efficacy and safety of treatment with ciclosporinor infliximab are comparable in patients with severe ulcerativecolitis (UC) (Laharie D et al, Lancet, 2012). Reduction ofduration of hospital stay has important impact on treatmentcosts.Aim: To analyse duration of hospital stay and costs in patientsadmitted for severe UC receiving treatment with ciclosporin orinfliximab.Methods: We carried out a retrospective analysis of patientswith steroid-refractory UC treated with intravenous ciclosporinor infliximab. Adult and paediatric patients were included whowere naïve to either therapy and admitted between March2004 and August 2012 at a single tertiary referral centre.Information was retrieved from patient records. Length ofhospital stay from initiation of rescue therapy to time ofdischarge was analyzed. Hospital costs for both treatmentgroups were analyzed.Results: A total of 42 patients (mean age 35 years; 43% female)were included in the analysis, with 26 (range 17 56 years) inthe ciclosporin and 16 (range 16 69 years) in the infliximabgroup. Patient characteristic showed no statistically significantdifference between the two groups: median duration of disease