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Affiliations
Antonio Tursi
Territorial Gastroenterology Service, ASL BAT, Andria; Department of Medical and Surgical Sciences, Post- graduate School of Digestive Diseases, Catholic University, Rome, Italy
Giammarco Mocci
Division of Gastroenterology, Brotzu Hospital, Cagliari, Italy
Walter Elisei
Division of Gastroenterology, S. Camillo Hospital, Rome, Italy
Leonardo Allegretta
Division of Gastroenterology, Santa Caterina Novella Hospital, Galatina (LE), Italy
Raffaele Colucci
Digestive Endoscopy Unit, San Matteo degli Infermi Hospital, Spoleto (PG), Italy
Nicola Della Valle
Division of Gastroenterology, A.O. Ospedali Riuniti, Foggia, Italy
Antonio De Medici
Territorial Gastroenterology Service, PST Catanzaro Lido, Catanzaro, Italy
Roberto Faggiani
Division of Gastroenterology, S. Camillo Hospital, Rome, Italy
Antonio Ferronato
Digestive Endoscopy Unit, AULSS7 Pedemontana, Santorso (VI), Italy
Giacomo Forti
Division of Digestive Endoscopy, S. Maria Goretti Hospital, Latina, Italy
Tiziana Larussa
Department of Health Science, University of Catanzaro, Catanzaro, Italy
Roberto Lorenzetti
Division of Gastroenterology, PTP Nuovo Regina Margherita, Roma, Italy
Francesco Luzza
Department of Health Science, University of Catanzaro, Catanzaro, Italy
Antonio Penna
Territorial Gastroenterology Service, ASL BA, Bari, Italy
Giuseppe Pranzo
Ambulatory for IBD Treatment, Valle D’Itria Hospital, Martina Franca (TA), Italy
Stefano Rodinò
Division of Gastroenterology, Ciaccio-Pugliese Hospital, Catanzaro, Italy
Rodolfo Sacco
Division of Gastroenterology, A.O. Ospedali Riuniti, Foggia, Italy
Ladislava Sebkova
Division of Gastroenterology, Ciaccio-Pugliese Hospital, Catanzaro, Italy
Costantino Zampaletta
Division of Gastroenterology, Belcolle Hospital, Viterbo, Italy
Camilla Graziosi
Division of Gastroenterology, Belcolle Hospital, Viterbo, Italy
Marcello Picchio
Division of General Surgery, P. Colombo Hospital, ASL Roma 6, Velletri (Roma), Italy
Irene Maria Bambina Bergna
Gastroenterology Unit, Department of Biomedical and Clinical Sciences, L. Sacco University Hospital, Milan, Italy
Giovanni Maconi
Gastroenterology Unit, Department of Biomedical and Clinical Sciences, L. Sacco University Hospital, Milan, Italy
How to Cite
Long-term, Real-life, Observational Study in Treating Outpatient Ulcerative Colitis with Golimumab
- Antonio Tursi ,
- Giammarco Mocci ,
- Walter Elisei ,
- Leonardo Allegretta ,
- Raffaele Colucci ,
- Nicola Della Valle ,
- Antonio De Medici ,
- Roberto Faggiani ,
- Antonio Ferronato ,
- Giacomo Forti ,
- Tiziana Larussa ,
- Roberto Lorenzetti ,
- Francesco Luzza ,
- Antonio Penna ,
- Giuseppe Pranzo ,
- Stefano Rodinò ,
- Rodolfo Sacco ,
- Ladislava Sebkova ,
- Costantino Zampaletta ,
- Camilla Graziosi ,
- Marcello Picchio ,
- Irene Maria Bambina Bergna ,
- Giovanni Maconi
Abstract
Background and Aims: Several studies have found Golimumab (GOL) effective and safe in the short-term treatment of ulcerative colitis (UC), but few long-term data are currently available from real world. Our aim was to assess the long-term real-life efficacy and safety of GOL in managing UC outpatients in Italy.
Methods: A retrospective multicenter study assessing consecutive UC outpatients treated with GOL for at least 3-month of follow-up was made. Primary endpoints were the induction and maintenance of remission in UC, defined as Mayo score ≤2. Several secondary endpoints, including clinical response, colectomy rate, steroid free remission and mucosal healing, were also assessed during the follow-up.
Results: One hundred and seventy-eight patients were enrolled and followed up for a median (IQR) time of 9 (3-18) months (mean time follow-up: 33.1±13 months). Clinical remission was achieved in 57 (32.1%) patients: these patients continued with GOL, but only 6 patients (3.4%) were still under clinical remission with GOL at the 42nd month of follow-up. Clinical response occurred in 64 (36.4%) patients; colectomy was performed in 8 (7.8%) patients, all of them having primary failure. Steroid-free remission occurred in 23 (12.9%) patients, and mucosal healing was achieved in 29/89 (32.6%) patients. Adverse events occurred in 14 (7.9%) patients.
Conclusions: Golimumab does not seem able to maintain long-term remission in UC in real life. The safety profile was good.