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

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...

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Bibliographic Details
Published in:Digestive diseases and sciences 2020-06, Vol.65 (6), p.1767-1776
Main Authors: Bossa, Fabrizio, Biscaglia, Giuseppe, Valvano, Maria Rosa, Costantino, Giuseppe, Lauria, Angelo, Clemente, Rocco, Ferracane, Concetta, Shahini, Endrit, Mendolaro, Marco, Grossi, Laurino, Mazzuoli, Silvia, Rispo, Antonio, Pranzo, Giuseppe, Sebkova, Ladislava, Tursi, Antonio, Miranda, Agnese, Patturelli, Marta, Spagnuolo, Rocco, Ricciardelli, Cristina, Sgarro, Caterina, Paese, Pietro, Inserra, Gaetano, Azzarone, Alessandro, Nardone, Olga, Fries, Walter, Buccianti, Nello, Privitera, Antonino Carlo, Principi, Maria Beatrice, Cappello, Maria, Guglielmi, Francesco William, Romano, Marco, Riegler, Gabriele, Fanigliulo, Libera, Melina, Raffaele, Andriulli, Angelo
Format: Article
Language:English
Subjects:
Analysis
Antibodies
Biochemistry
Clinical medicine
Endoscopy
Feces
Gastroenterology
Hepatology
Inflammation
Inflammatory bowel disease
Laboratories
Medical colleges
Medical research
Medicine
Medicine & Public Health
Medicine, Experimental
Monoclonal antibodies
Oncology
Original Article
Patients
Questionnaires
Safety and security measures
Studies
TNF inhibitors
Transplant Surgery
Tumor necrosis factor
Ulcerative colitis
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Summary: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  
ISSN:0163-2116
1573-2568
DOI:10.1007/s10620-019-05904-z