P562 Effectiveness and safety of golimumab in inducing remission in outpatient ulcerative colitis patients: a first ‘real-life’ experience in primary gastroenterology centres in Italy
A. Tursi1, L. Allegretta2, N. Della Valle3, Y. Hadad4, A. Penna*5, G. Pranzo6, C. Ricciardelli7, P. Paiano7, M. Picchio8
1Azienda Sanitaria Locale BAT, Servizio di Gastroenterologia Territoriale, Andria, Italy, 2’Santa Caterina Novella’ Hospital, Division of Gastroenterology, Galatina (LE), Italy, 3A.O. ‘Ospedali Riuniti’, Division of Gastroenterology, Foggia, Italy, 4’Card. Panico’ Hospital, Division of Internal Medicine, Tricase (LE), Italy, 5’S. Paolo’ Hospital, Division of Gastroenterology, Bari, Italy, 6’Valle D’Itria’ Hospital, Ambulatory of IBD, Martina Franca (TA), Italy, 7’Veris Delli Ponti’ Hospital, Division of Gastroenterology, Scorrano (LE), Italy, 8’P. Colombo’ Hospital, ASL RMH, Division of Surgery, Velletri (Rome), Italy
Golimumab (GOL) has been approved in Italy for the treatment of ulcerative colitis (UC) unresponsive to standard treatments. Our aim was to assess the efficacy and safety of GOL in inducing remission in outpatients UC patients in primary gastroenterology centres in Apulia (Southern Italy).
Enrolled were 23 patients (11 male and 12 female, median age 44 years, range 21–65 years), 4 of them previously treated with infliximab (IFX). Clinical activity severity was scored according to the Mayo score. Patients were clinically assessed at entry, after 2, 6, and 8 weeks. The primary endpoint was clinical remission, defined as partial Mayo score ≤ 2, at week 8. The secondary endpoints included clinical response to treatment, defined as partial Mayo score reduction of at least 2 points, as well as safety of the drug, defined as occurrence of adverse events during induction. Induction dose of GOL was 200 mg at week 0, 100 mg at week 2, and then 100 or 50 mg at week 6 according to body weight.
Clinical remission was obtained in 8 (34.8%) patients. Clinical response to treatment was obtained in all patients. At univariate analysis female sex and Mayo score ≤ 8 at entry were significantly related to clinical remission. At logistic regression, only Mayo score ≤ 8 was significantly associated with clinical remission.
GOL seem to be effective in inducing remission in outpatient UC patients in real life. Mayo score is the single independent factor influencing the outcome.