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Monday, October 22, 2012

Type: Session title: Time: Room: Poster Session IBD I 09.00-17.00 Hall 1 CLINICAL RELEVANCE OF ADALIMUMAB SERUM CONCENTRATION AND ANTI-ADALIMUMAB ANTIBODIES IN PATIENTS WITH CROHN DISEASE DURING LONG-TERM FOLLOW-UP Giorgia Bodini Vincenzo Savarino Lorenzo Gemignani Valentina Fazio Elisa Giambruno Pietro Dulbecco Edoardo Savarino Poster Presenter Co-Author Co-Author Co-Author Co-Author Co-Author Co-Author

P0296

INTRODUCTION/OBJECTIVES: Trough serum levels of Adalimumab (ADA) and anti-ADA antibodies have been associated to loss of response in patients with inflammatory-related diseases. However, little is known regarding the clinical influence of these features in patients with Crohns disease (CD) during long-term follow-up. AIMS & METHODS: To evaluate the course of ADA serum concentration and anti-ADA antibodies formation and their clinical relevance during a long-term (2 year) follow-up period of patients with CD. In this prospective study, 22 consecutive infliximab-nave patients (13M/9F) with CD, who achieved remission and in maintenance treatment with ADA, were included in a follow-up program. Blood samples were drawn at standardized time points (i.e. at 6, 12, 18, 24 months and in case of CD relapse) just before injection of ADA. Trough ADA serum concentration and anti-ADA antibodies were measured using an enzyme-linked immunosorbent assays (Matriks biotek). Disease activity was assessed at the same points by means of the Harvey-Bradshaw Index score (HBI, remission <5, mild disease 5-7, moderate disease 8-16, severe disease > 16) and CRP blood level (normal if <5 mg/L). RESULTS: Data on clinical features are shown as mean (range) in the table. Based on HBI score, 10/22 (45%) patients demonstrated sustained clinical remission until the end of follow-up. Out of the remaining 12 patients , 3 (14%) developed a mild disease, 6 (27%) a moderate disease and 3 (14%) a severe disease requiring therapeutic intervention. CRP levels paralleled with the HBI scores, since patients in remission had a mean CRP level within the normal range and lower than patients with disease activity (p<0.01). Significantly higher ADA trough serum concentrations were measured throughout the follow-up period in patients in remission as compared to patients who developed disease activity, independently of the severity (p<0.01). Anti-ADA antibodies were present in 9% of the patients and did not affected ADA trough serum concentration.

Patients with CD classified by means of HBI Remission n=10 Parameters p Value (Anova) HBI score, n ADA concentration, mcg/ml CRP, mg/L 4 (3-4) 8,1 (6,7-9,2) 1 (0,-4) 6 (5-7) 5,8 (5,26,1) 3 (1.5,6) 9 (8-11) 3,9 (3,2-4,7) 10 (3,5-18,7) 17 (16-17) 1 (0,1-2,6) 18 (5,934,3) <0,01 <0,01 <0,01 Mild Disease n=3 Moderate Disease n=6 Severe Disease n=3

CONCLUSION: Lower ADA trough serum concentrations are associated with loss of response and both clinical and biological relapse during a 2 year follow-up period. Development of anti-ADA is a rare event and seems not to modify patients outcome.