Real-Life Effectiveness and Safety of Golimumab and Its Predictors of Response in Patients with Ulcerative Colitis.

Autor: Bossa F; Gastroenterology Division, Fondazione Casa Sollievo della Sofferenza IRCCS, Viale Cappuccini, 1, 71013, San Giovanni Rotondo, Italy. kostu.diamantopulu@gmail.com., Biscaglia G; Gastroenterology Division, Fondazione Casa Sollievo della Sofferenza IRCCS, Viale Cappuccini, 1, 71013, San Giovanni Rotondo, Italy., Valvano MR; Gastroenterology Division, Fondazione Casa Sollievo della Sofferenza IRCCS, Viale Cappuccini, 1, 71013, San Giovanni Rotondo, Italy., Costantino G; Clinical Unit for Chronic Bowel Disorders, University of Messina, Messina, Italy., Lauria A; Grande Ospedale Metropolitano Reggio Calabria, Reggio Calabria, Italy., Clemente R; UOC di Medicina Generale, Ospedale Madonna delle Grazie, Matera, Italy., Ferracane C; IBD Unit Azienda Ospedaliera per l'Emergenza 'Cannizzaro', Catania, Italy., Shahini E; Emergency and Organ Transplantation Department, Section of Gastroenterology, AOU Policlinico, Bari, Italy., Mendolaro M; Gastroenterology and Hepatology Section, DIBIMIS, University of Palermo School of Medicine, Palermo, Italy., Grossi L; Gastroenterology Unit, University of Pescara, Pescara, Italy., Mazzuoli S; Gastroenterology and Artificial Nutrition Department, 'San Nicola Pellegrino' Hospital, Trani, Italy., Rispo A; Clinical Medicine and Surgery Department, Section of Gastroenterology, University 'Federico II' of Naples, Naples, Italy., Pranzo G; Surgery Unit, Valle D'Itria Hospital, Martina Franca, Italy., Sebkova L; Gastroenterology Unit, Pugliese Ciaccio Hospital, Catanzaro, Italy., Tursi A; Gastroenterology Service, ASL BAT, Andria, Italy., Miranda A; 'F. Magrassi' Clinical and Experimental Medicine Department, Università della Campania 'Luigi Vanvitelli', Naples, Italy., Patturelli M; UOSD Gastroenterologia, Università della Campania 'Luigi Vanvitelli', Naples, Italy., Spagnuolo R; Gastroenterology and Digestive Endoscopy Department, University of Catanzaro, Catanzaro, Italy., Ricciardelli C; Gastroenterology Unit, Poggiardo Hospital, Poggiardo, Italy., Sgarro C; Gastroenterology and Digestive Endoscopy Unit, OORR, Foggia, Italy., Paese P; Gastroenterology Unit, Ospedale Annunziata, Cosenza, Italy., Inserra G; Internal Medicine, Medical and Pediatric Sciences Department, University of Catania, Catania, Italy., Azzarone A; Gastroenterology Unit, Ospedale San Paolo, Bari, Italy., Nardone O; Clinical Medicine and Surgery Department, Section of Gastroenterology, University 'Federico II' of Naples, Naples, Italy., Fries W; Clinical Unit for Chronic Bowel Disorders, University of Messina, Messina, Italy., Buccianti N; UOC di Medicina Generale, Ospedale Madonna delle Grazie, Matera, Italy., Privitera AC; IBD Unit Azienda Ospedaliera per l'Emergenza 'Cannizzaro', Catania, Italy., Principi MB; Emergency and Organ Transplantation Department, Section of Gastroenterology, AOU Policlinico, Bari, Italy., Cappello M; Gastroenterology and Hepatology Section, DIBIMIS, University of Palermo School of Medicine, Palermo, Italy., Guglielmi FW; Gastroenterology and Artificial Nutrition Department, 'San Nicola Pellegrino' Hospital, Trani, Italy., Romano M; 'F. Magrassi' Clinical and Experimental Medicine Department, Università della Campania 'Luigi Vanvitelli', Naples, Italy., Riegler G; UOSD Gastroenterologia, Università della Campania 'Luigi Vanvitelli', Naples, Italy., Fanigliulo L; Gastroenterology Unit, Ospedale Santissima Annunziata, Taranto, Italy., Melina R; Gastroenterology Unit, Ospedale San Giuseppe Moscati, Avellino, Italy., Andriulli A; Gastroenterology Division, Fondazione Casa Sollievo della Sofferenza IRCCS, Viale Cappuccini, 1, 71013, San Giovanni Rotondo, Italy.
Jazyk: angličtina
Zdroj: Digestive diseases and sciences [Dig Dis Sci] 2020 Jun; Vol. 65 (6), pp. 1767-1776. Date of Electronic Publication: 2019 Nov 13.
DOI: 10.1007/s10620-019-05904-z
Abstrakt: Background: Golimumab is a new anti-TNF-alpha monoclonal antibody for patients with ulcerative colitis.
Aims: To assess the short- and long-term effectiveness and safety of golimumab in daily clinical practice and to identify predictors of response.
Methods: Consecutive patients treated with golimumab in 22 Italian centers were enrolled. Clinical, laboratory, and endoscopic data were prospectively collected before and during treatment. A subgroup of patients completed a questionnaire to assess personal satisfaction with a golimumab autoinjector system.
Results: A total of 196 patients were included. After 3 months, 130 patients were responders (66.3%) and showed significant reductions in mean partial, total, and endoscopic Mayo scores and in mean ESR, C-reactive protein, and fecal calprotectin levels (p < 0.001). Multivariate analysis revealed that a higher total Mayo score (p < 0.001, OR 1.5, 95% CI 1.2-1.8) and naïve status to anti-TNF-alpha (p = 0.015, OR 3.0, 95% CI 1.2-7.5) were predictive of a favorable response. Seventy-seven (39.3%) of the 130 responders maintained a response at month 12 of therapy. There were 17 adverse events, 28 patients needed hospitalization, and 15 patients underwent surgery. Self-administration of the drug was appreciated by most patients.
Conclusions: The efficacy and safety of golimumab in daily clinical practice were confirmed for the short- and long-term treatment of patients with active ulcerative colitis. Patients naïve to the anti-TNF-alpha monoclonal antibody and those with a higher total Mayo score were more likely to respond to golimumab.
Databáze: MEDLINE
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