P362. Survey from the Registry of the Italian Group of IBD on anti-TNF α therapy in IBD
A. Redaelli1, S. Genise2, R. D'Incà3, F. Castiglione4, A. Orlando5, D. Valpiani6, R. D'Urso4, R. Pica7, M. Fortuna8, V. Annese2, on behalf of IG-IBD, 1Gastronterology, Monza, Italy, 2Gastroenterology, Florence, Italy, 3Gastroenterology, Padua, Italy, 4Gastroenterology, Naples, Italy, 5Gastroenterology, Palermo, Italy, 6Gastroenterology, Forlì, Italy, 7Gastroenterology, Rome, Italy, 8Gastroenterology, Negrer-Verona, Italy
The introduction of anti-TNF-alpha therapy has significantly changed the management of Inflammatory bowel disease (IBD), presumably with impact on disease course in terms of need of hospitalization and surgery. However, the cost of medical therapy is dramatically increasing with alarming signals from the third payer. For this reason a priority of the web-based Registry of the Italian Group for IBD (IG-IBD) has been the progressive inclusion and evaluation of patients receiving biologic therapy.
Thirty-two community and referral centers of gastroenterology with dedicated IBD units have been connected through the IG-IBD with a web-based platform. Starting from 1st January 2010 consecutive IBD patients with ongoing anti-TNF-alpha therapy have been included in the data base. In this first evaluation we focused our analysis on some preliminary aspects of the therapy.
673 patients under biologic therapy have been identified. 501 were Crohn's disease (CD) patients, with a mean age of 28±12, and mean disease duration of 7±4. 162 were Ulcerative colitis (UC) patients, with a mean age of 31±8, and mean disease duration of 6±4. Infliximab and Adalimumab were utilized in 67% and 54% of patients, respectively. 21% of patients were exposed to both agents, while 356 patients (53%) received concomitant therapy with thiopurines (84%) or methotrexate (16%). Reasons for discontinuation were remission (25%), primary failure (34%), and adverse events (13%). No drug-related mortality was reported. Main adverse events causing discontinuation were infusion reactions (54%), skin reactions (4.5%), opportunistic infections (9%), abscess (9%), neurologic symptoms (7%), and neoplasia (one case of testicular seminoma).
Because of the increasing use and raising cost of biologic therapy in IBD, the web-based platform will allow the evaluation of efficacy, adverse events, together with need for hospitalization and surgery.
IG-IBD Investigators/Centers not included in the authorships: L. Alessandro (Genova), F. Costa (Pisa), A. Lanzini (Brescia), M. Devani (Rho), P. Paoluzi (Roma), C. Papi (Roma), A. Bonfanti (S. Donato Milanese), A. Gasbarrini (Roma), F. Bossa (S. Giovanni R), W. Fries (Messina), S. Saibeni (Milano), F. Pallone (Roma), A. Ferronato (Vicenza), G. Grasso (Varese), A. Kohn (Roma), M. Cappello (Palermo), F. Magnolfi (Arezzo), G. Basilisco (Milano), A. Armuzzi (Roma), L. Benazzato (Verona), R. Sablich (Pordenone), G. Inserra (Catania), A. Azzarone (Bari).