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Effectiveness and Safety of Golimumab in Treating Outpatient Ulcerative Colitis: A Real-Life Prospective, Multicentre, Observational Study in Primary Inflammatory Bowel Diseases Centers

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Antonio Tursi1, Leonardo Allegretta2, Nello Buccianti3, Nicola Della Valle4, Walter Elisei5, Giacomo Forti6, Roberto Faggiani7, Sara Gallina7, Yusef Hadad8, Tiziana Larussa9, Angelo Lauria10, Francesco Luzza9, Roberto Lorenzetti11, Giammarco Mocci12, Antonio Penna13, Natale Polimeni10, Giuseppe Pranzo14, Cristina Ricciardelli15, Costantino Zampaletta7, Marcello Picchio16

1) Gastroenterology Service, ASL BAT, Andria;
2) Div. Gastroenterology, Santa Caterina Novella Hospital, Galatina (LE);
3) Div. Internal Medicine, Madonna delle Grazie Hospital, Matera;
4) Div. Gastroenterology, A.O. Ospedali Riuniti, Foggia;
5) Div.Gastroenterology, ASL Roma 6, Albano Laziale, Roma;
6) Div.Digestive Endoscopy, S. Maria Goretti Hospital, Latina;
7) Div.Gastroenterology, Belcolle Hospital, Viterbo;
8) Div.Internal Medicine, Card. Panico Hospital, Tricase (LE);
9) Depart.Health Science, University of Catanzaro, Catanzaro;
10) Div. Gastroenterology, A.O. Bianchi-Melacrino-Morelli, Reggio Calabria;
11) Div. Gastroenterology, PTP Nuovo Regina Margherita, Roma;
12) Div. Gastroenterology, Brotzu Hospital, Cagliari;
13) Div. Gastroenterology, S. Paolo Hospital, Bari;
14) Ambulatory for IBD Treatment, Valle D’Itria Hospital, Martina Franca (TA);
15) Div. Veris Delli Ponti Hospital, Scorrano (LE);
16) Div. General Surgery, P. Colombo Hospital, ASL Roma 6, Velletri, Roma, Italy

DOI: http://dx.doi.org/10.15403/jgld.2014.1121.263.trs

Background & Aims: Golimumab (GOL) has been recently approved in Italy for the treatment of ulcerative colitis (UC) unresponsive to standard treatments. Our aims were to assess the real-life efficacy and safety of GOL in managing UC outpatients in Italian primary Inflammatory Bowel Diseases (IBD) centres.
Methods: Consecutive UC outpatients with at least 3-months follow-up were enrolled. Primary end-point was the induction and maintenance of remission in UC, defined as Mayo score ≤2, at 6-month follow-up.
Results: Ninety-three patients were enrolled. At 6-month follow-up, remission was obtained in 34 (36.5%) patients. Shorter duration of disease was the only significant predictive factor of remission. Clinical response was achieved in 60 (64.5%) patients, while mucosal healing (MH) was obtained in 18 (19.3%) patients. Sixteen (47.0%) patients under remission were still under therapy with steroids. C-reactive protein and fecal calprotectin significantly dropped during the follow-up (p<0.001 for both proteins). Adverse events occurred in 4 (4.3%) patients and 3 of them stopped treatment. Colectomy was performed in only one patient (1.1%).
Conclusions: Golimumab seems to be safe and effective in inducing and maintaining remission in real life UC outpatients.
Key words: induction – golimumab – remission – treatment – ulcerative colitis.
Abbreviations: ADA: Adalimumab; CRP: C-reactive Protein; GOL: Golimumab; FC: Fecal calprotectin; IBD: Inflammatory Bowel Diseases; IFX: Infliximab; IQR: Interquartile range; MH: Mucosal Healing; SC: Subcutaneously; TBC: Tuberculosis; TNFα: Tumor necrosis factor α; UC: Ulcerative Colitis.