Long-term, Real-life, Observational Study in Treating Outpatient Ulcerative Colitis with Golimumab

Authors

  • 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

DOI:

https://doi.org/10.15403/jgld-3992

Keywords:

induction, follow-up, golimumab, remission, treatment, ulcerative colitis

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.

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Published

2021-12-21

How to Cite

1.
Tursi A, Mocci G, Elisei W, Allegretta L, Colucci R, Della Valle N, De Medici A, Faggiani R, Ferronato A, Forti G, Larussa T, Lorenzetti R, Luzza F, Penna A, Pranzo G, Rodinò S, Sacco R, Sebkova L, Zampaletta C, Graziosi C, Picchio M, Bergna IMB, Maconi G. Long-term, Real-life, Observational Study in Treating Outpatient Ulcerative Colitis with Golimumab. JGLD [Internet]. 2021 Dec. 21 [cited 2026 May 17];30(4):456-61. Available from: https://jgld.ro/jgld/index.php/jgld/article/view/3992

Issue

Vol. 30 No. 4: December 2021

Section

Original Article