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

• Published in: Journal of gastrointestinal and liver diseases : JGLD 2021-12, Vol.30 (4), p.456-461
• Main Authors: Tursi, Antonio, Mocci, Giammarco, Elisei, Walter, Allegretta, Leonardo, Colucci, Raffaele, Della Valle, Nicola, De Medici, Antonio, Faggiani, Roberto, Ferronato, Antonio, Forti, Giacomo, Larussa, Tiziana, Lorenzetti, Roberto, Luzza, Francesco, Penna, Antonio, Pranzo, Giuseppe, Rodinò, Stefano, Sacco, Rodolfo, Sebkova, Ladislava, Zampaletta, Costantino, Graziosi, Camilla, Picchio, Marcello, Bergna, Irene Maria Bambina, Maconi, Giovanni
• Format: Article
• Language: English
• ISSN: 1841-8724; 1842-1121
• DOI: 10.15403/jgld-3992

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.