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

Authors
  • Bossa, Fabrizio1
  • Biscaglia, Giuseppe2
  • Valvano, Maria Rosa2
  • Costantino, Giuseppe3
  • Lauria, Angelo4
  • Clemente, Rocco5
  • Ferracane, Concetta6
  • Shahini, Endrit7
  • Mendolaro, Marco8
  • Grossi, Laurino9
  • Mazzuoli, Silvia10
  • Rispo, Antonio11
  • Pranzo, Giuseppe12
  • Sebkova, Ladislava13
  • Tursi, Antonio14
  • Miranda, Agnese15
  • Patturelli, Marta16
  • Spagnuolo, Rocco17
  • Ricciardelli, Cristina18
  • Sgarro, Caterina19
  • And 15 more
  • 1 Gastroenterology Division, Fondazione Casa Sollievo della Sofferenza IRCCS, Viale Cappuccini, 1, 71013, San Giovanni Rotondo, Italy. [email protected] , (Italy)
  • 2 Gastroenterology Division, Fondazione Casa Sollievo della Sofferenza IRCCS, Viale Cappuccini, 1, 71013, San Giovanni Rotondo, Italy. , (Italy)
  • 3 Clinical Unit for Chronic Bowel Disorders, University of Messina, Messina, Italy. , (Italy)
  • 4 Grande Ospedale Metropolitano Reggio Calabria, Reggio Calabria, Italy. , (Italy)
  • 5 UOC di Medicina Generale, Ospedale Madonna delle Grazie, Matera, Italy. , (Italy)
  • 6 IBD Unit Azienda Ospedaliera per l'Emergenza "Cannizzaro", Catania, Italy. , (Italy)
  • 7 Emergency and Organ Transplantation Department, Section of Gastroenterology, AOU Policlinico, Bari, Italy. , (Italy)
  • 8 Gastroenterology and Hepatology Section, DIBIMIS, University of Palermo School of Medicine, Palermo, Italy. , (Italy)
  • 9 Gastroenterology Unit, University of Pescara, Pescara, Italy. , (Italy)
  • 10 Gastroenterology and Artificial Nutrition Department, "San Nicola Pellegrino" Hospital, Trani, Italy. , (Italy)
  • 11 Clinical Medicine and Surgery Department, Section of Gastroenterology, University "Federico II" of Naples, Naples, Italy. , (Italy)
  • 12 Surgery Unit, Valle D'Itria Hospital, Martina Franca, Italy. , (Italy)
  • 13 Gastroenterology Unit, Pugliese Ciaccio Hospital, Catanzaro, Italy. , (Italy)
  • 14 Gastroenterology Service, ASL BAT, Andria, Italy. , (Italy)
  • 15 "F. Magrassi" Clinical and Experimental Medicine Department, Università della Campania "Luigi Vanvitelli", Naples, Italy. , (Italy)
  • 16 UOSD Gastroenterologia, Università della Campania "Luigi Vanvitelli", Naples, Italy. , (Italy)
  • 17 Gastroenterology and Digestive Endoscopy Department, University of Catanzaro, Catanzaro, Italy. , (Italy)
  • 18 Gastroenterology Unit, Poggiardo Hospital, Poggiardo, Italy. , (Italy)
  • 19 Gastroenterology and Digestive Endoscopy Unit, OORR, Foggia, Italy. , (Italy)
  • 20 Gastroenterology Unit, Ospedale Annunziata, Cosenza, Italy. , (Italy)
  • 21 Internal Medicine, Medical and Pediatric Sciences Department, University of Catania, Catania, Italy. , (Italy)
  • 22 Gastroenterology Unit, Ospedale San Paolo, Bari, Italy. , (Italy)
  • 23 Gastroenterology Unit, Ospedale Santissima Annunziata, Taranto, Italy. , (Italy)
  • 24 Gastroenterology Unit, Ospedale San Giuseppe Moscati, Avellino, Italy. , (Italy)
Type
Published Article
Journal
Digestive Diseases and Sciences
Publisher
Springer-Verlag
Publication Date
Jun 01, 2020
Volume
65
Issue
6
Pages
1767–1776
Identifiers
DOI: 10.1007/s10620-019-05904-z
PMID: 31722059
Source
Medline
Keywords
Language
English
License
Unknown

Abstract

Golimumab is a new anti-TNF-alpha monoclonal antibody for patients with ulcerative colitis. To assess the short- and long-term effectiveness and safety of golimumab in daily clinical practice and to identify predictors of response. 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. 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. 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.

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