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P230. Adalimumab in active ulcerative colitis: A “real-life” observational study

A. Armuzzi1, L. Biancone2, M. Daperno3, A. Coli4, V. Annese5, S. Ardizzone6, P. Balestrieri7, F. Bossa8, F. Castiglione9, M. Cicala7, S. Danese10, R. D'Incà11, P. Dulbecco12, G. Feliciangeli13, W. Fries14, S. Genise5, P. Gionchetti15, S. Gozzi16, A. Kohn17, R. Lorenzetti18, M. Milla5, S. Onali2, A. Orlando19, L.G. Papparella17, D. Pugliese1, S. Renna19, C. Ricci20, F. Rizzello15, R. Sostegni3, L. Guidi1, C. Papi21

1Complesso Integrato Columbus, Gastroenterology Unit, Rome, Italy; 2GI Unit, “Tor Vergata” University, Rome, Italy; 3Azienda Ospedaliera Ordine Mauriziano, S.C. Gastroenterologia, c/o Segreteri Endoscopia Digestiva, Torino, Italy; 4General Medicine, Azienda Ospedaliera Universitaria Pisana, Pisa, Italy; 5University Hospital Careggi, Dept. Medical & Surgical Sciences, Division of Gastroenterology, Florence, Italy; 6IBD Unit, L. Sacco Hospital, Milan, Italy; 7University Campus Bio-Medico, Rome, Italy; 8GI Unit, IRCCS Casa Sollievo della Sofferenza, San Giovanni Rotondo, Italy; 9University Federico II Of Naples, Gastroenterology, Naples, Italy; 10IBD Unit, Istituto Clinico Humanitas, Rozzano, Italy; 11Department of Surgical and Gastroenterological Sciences, University of Padua, Padua, Italy; 12GI Unit, Department of Internal Medicine, Genoa University, Genoa, Italy; 13GI Unit, Macerata Hospital, Macerata, Italy; 14University of Messina, Dip di Medicina Interna e Terapia Medica U.O. Malattie di Fegato e dell'Apparato Digerente, Messina, Italy; 15University of Bologna, Dip di Medicina Interna e Gastroenterologia I Clinica Medica e Terapia Medica, Bologna, Italy; 16GI Unit, San Donato Hospital, Arezzo, Italy; 17San Camillo Forlanini Hospitals, U.O. Gastroenterologia, Rome, Italy; 18GI Unit, PTP Nuovo Regina Margherita, Rome, Italy; 19Palermo University, Villa Sofia‑V. Cervello Hospital/Department of Medicine, Palermo, Italy; 20GI Unit, Spedali Civili, Brescia, Italy; 21S. Filippo Neri Hospital, UOC Gastroenterologia & Epatologia, Rome, Italy

Background: The effectiveness of adalimumab (ADA) in the treatment of ulcerative colitis (UC) is under debate. Controlled trials have shown that ADA is significantly better than placebo, but the absolute benefit is small. We report data on the effectiveness of ADA in a large cohort of patients with active UC.

Methods: Patients with active UC treated with ADA in 21 Italian referral centres have been collected. Clinical characteristics before and after ADA treatment were reported in a common database. Active UC was defined as a partial Mayo score ≥2. All patients received ADA induction and maintenance regimen and concomitant medications according to clinical judgement. Co-primary endpoints were clinical remission (partial Mayo score ≤1) at 4, 12, 24 and 54 weeks. Secondary endpoints were sustained clinical remission, steroid discontinuation, endoscopic remission and need of colectomy.

Results: Eighty patients (median age 39 years, IQR 31–47) have been enrolled. Main indications for ADA treatment were steroid-dependency (45%), steroid-resistance (24%) and extraintestinal manifestations (14%). Most of patients (79%) received previous infliximab treatment. Median partial Mayo score at baseline was 6 (IQR 4–7). ADA induction regimen was 160/80 mg (90%) or 80/40 mg (10%) and maintenance treatment was 40 mg every other week for a median time of 11 months (IQR 4–16). During follow up 30% of patients required dose-escalation. Clinical remission at 4, 12, 24 and 54 weeks was achieved in 13/80 (16.2%), 20/76 (26.3%), 25/73 (34.2%) and 23/57 (40.3%) patients, respectively. Sustained clinical remission at 12, 24 and 54 weeks was achieved in 10/57 (17.5%) patients. 33 of 55 patients (60%) receiving steroids at baseline were able to discontinue them. 47 patients underwent baseline and follow-up endoscopy after a median of 11 months (IQR 3–13). Endoscopic remission was achieved in 21/47 patients (45%). During the study period, 18 patients (22.5%) underwent colectomy after a median of 5.5 months (IQR 2–14). No significant differences in remission rates at 4, 12, 24 and 54 weeks and colectomy rates were observed between anti‑TNF alpha naïve and non-naïve patients.

Conclusions: In this large “real-life” experience ADA appeared to be effective in active UC. One fourth of patients achieved clinical remission within three months. In patients receiving scheduled maintenance treatment for one year the remission rate was 40%. Although ADA shows a steroid-sparing effect, the probability of colectomy for treatment failure is high.