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

Fabrizio Bossa, Giuseppe Biscaglia, Maria Rosa Valvano, Giuseppe Costantino, Angelo Lauria, Rocco Clemente, Concetta Ferracane, Endrit Shahini, Marco Mendolaro, Laurino Grossi, Silvia Mazzuoli, Antonio Rispo, Giuseppe Pranzo, Ladislava Sebkova, Antonio Tursi, Agnese Miranda, Marta Patturelli, Rocco Spagnuolo, Cristina Ricciardelli, Caterina SgarroPietro Paese, Gaetano Inserra, Alessandro Azzarone, Olga Nardone, Walter Fries, Nello Buccianti, Antonino Carlo Privitera, Maria Beatrice Principi, Maria Cappello, Francesco William Guglielmi, Marco Romano, Gabriele Riegler, Libera Fanigliulo, Raffaele Melina, Angelo Andriulli

Research output: Contribution to journalArticle

Abstract

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.

Original languageEnglish
JournalDigestive Diseases and Sciences
DOIs
Publication statusAccepted/In press - Jan 1 2019

Fingerprint

Ulcerative Colitis
Safety
Tumor Necrosis Factor-alpha
Monoclonal Antibodies
golimumab
Leukocyte L1 Antigen Complex
Self Administration
C-Reactive Protein
Hospitalization
Therapeutics
Multivariate Analysis

Keywords

  • Anti-TNF-alpha
  • Biologics
  • Golimumab
  • Inflammatory bowel disease
  • Ulcerative colitis

ASJC Scopus subject areas

  • Physiology
  • Gastroenterology

Cite this

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

In: Digestive Diseases and Sciences, 01.01.2019.

Research output: Contribution to journalArticle

Bossa, F, Biscaglia, G, Valvano, MR, Costantino, G, Lauria, A, Clemente, R, Ferracane, C, Shahini, E, Mendolaro, M, Grossi, L, Mazzuoli, S, Rispo, A, Pranzo, G, Sebkova, L, Tursi, A, Miranda, A, Patturelli, M, Spagnuolo, R, Ricciardelli, C, Sgarro, C, Paese, P, Inserra, G, Azzarone, A, Nardone, O, Fries, W, Buccianti, N, Privitera, AC, Principi, MB, Cappello, M, Guglielmi, FW, Romano, M, Riegler, G, Fanigliulo, L, Melina, R & Andriulli, A 2019, 'Real-Life Effectiveness and Safety of Golimumab and Its Predictors of Response in Patients with Ulcerative Colitis', Digestive Diseases and Sciences. https://doi.org/10.1007/s10620-019-05904-z
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. / Real-Life Effectiveness and Safety of Golimumab and Its Predictors of Response in Patients with Ulcerative Colitis. In: Digestive Diseases and Sciences. 2019.
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abstract = "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 na{\"i}ve 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 na{\"i}ve 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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T1 - Real-Life Effectiveness and Safety of Golimumab and Its Predictors of Response in Patients with Ulcerative Colitis

AU - Bossa, Fabrizio

AU - Biscaglia, Giuseppe

AU - Valvano, Maria Rosa

AU - Costantino, Giuseppe

AU - Lauria, Angelo

AU - Clemente, Rocco

AU - Ferracane, Concetta

AU - Shahini, Endrit

AU - Mendolaro, Marco

AU - Grossi, Laurino

AU - Mazzuoli, Silvia

AU - Rispo, Antonio

AU - Pranzo, Giuseppe

AU - Sebkova, Ladislava

AU - Tursi, Antonio

AU - Miranda, Agnese

AU - Patturelli, Marta

AU - Spagnuolo, Rocco

AU - Ricciardelli, Cristina

AU - Sgarro, Caterina

AU - Paese, Pietro

AU - Inserra, Gaetano

AU - Azzarone, Alessandro

AU - Nardone, Olga

AU - Fries, Walter

AU - Buccianti, Nello

AU - Privitera, Antonino Carlo

AU - Principi, Maria Beatrice

AU - Cappello, Maria

AU - Guglielmi, Francesco William

AU - Romano, Marco

AU - Riegler, Gabriele

AU - Fanigliulo, Libera

AU - Melina, Raffaele

AU - Andriulli, Angelo

PY - 2019/1/1

Y1 - 2019/1/1

N2 - 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.

AB - 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.

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KW - Biologics

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KW - Inflammatory bowel disease

KW - Ulcerative colitis

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