The PROSIT Cohort of Infliximab Biosimilar in IBD: A Prolonged Follow-up on the Effectiveness and Safety Across Italy

Alessandro Armuzzi, Gionata Fiorino, Angela Variola, Natalia Manetti, Walter Fries, Ambrogio Orlando, Giovanni Maconi, Fabrizio Bossa, Maria Cappello, Livia Biancone, Laura Cantoro, Francesco Costa, Renata D’Incà, Paolo Lionetti, Mariabeatrice Principi, Fabiana Castiglione, Maria L Annunziata, Antonio Di Sabatino, Maria Di Girolamo, Maria M TerpinClaudio C Cortelezzi, Simone Saibeni, Arnaldo Amato, Sandro Ardizzone, Luisa Guidi, Silvio Danese, Arianna Massella, Agostino Ventra, Giulia Rizzuto, Alessandro Massari, Francesco Perri, Vito Annese

Research output: Contribution to journalArticle

Abstract

We report a prospective, nationwide cohort evaluating the safety and effectiveness of CT-P13.A structured database was used to record serious adverse events (SAEs), clinical remission/response, inflammatory biomarkers (CRP and calprotectin), and endoscopic findings.Eight hundred ten patients with inflammatory bowel disease (IBD) (452 Crohn’s disease [CD]) were enrolled. Four hundred fifty-nine patients were naïve to anti-TNFα (group A), 196 had a previous exposure (group B), and the remaining 155 were switched to CT-P13 (group C). All patients were included in the safety evaluation with a mean follow-up of 345 ± 215 days and a total number of 6501 infusions. One hundred fifty-four SAEs were reported (19\, leading to cessation of the biosimilar in 103 subjects (12.7\. Infusion reactions were 71, leading to cessation of the biosimilar in 53 subjects (6.5\, being significantly more frequent in patients pre-exposed to anti-TNFα (P = 0.017). The efficacy of therapy was calculated in 754 IBD patients, with a mean follow-up of 329 ± 202 days. Forty-eight patients had a primary failure (6.4\, and 188 (25.6\ lost response during follow-up. Six hundred twenty-eight (364 CD) and 360 IBD patients (222 CD) completed the follow-up at 6 and 12 months, respectively. At 12 months, patients without loss of response were 71\ 64\ and 82\% in groups A, B, and C, respectively (log rank P = 0.01). Clinical/endoscopic scores and inflammatory biomarkers dropped significantly in CD and UC patients (P = 0.01 and P \lt; 0.0001) compared with baseline.In this large prospective cohort, no further signals of difference in safety and effectiveness of CT-P13 in IBD has been observed.
Original languageUndefined/Unknown
Pages (from-to)568-579
Number of pages12
JournalInflammatory Bowel Diseases
Volume25
Issue number3
DOIs
Publication statusPublished - Aug 1 2018

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The PROSIT Cohort of Infliximab Biosimilar in IBD: A Prolonged Follow-up on the Effectiveness and Safety Across Italy. / Armuzzi, Alessandro; Fiorino, Gionata; Variola, Angela; Manetti, Natalia; Fries, Walter; Orlando, Ambrogio; Maconi, Giovanni; Bossa, Fabrizio; Cappello, Maria; Biancone, Livia; Cantoro, Laura; Costa, Francesco; D’Incà, Renata; Lionetti, Paolo; Principi, Mariabeatrice; Castiglione, Fabiana; Annunziata, Maria L; Di Sabatino, Antonio; Di Girolamo, Maria; Terpin, Maria M; Cortelezzi, Claudio C; Saibeni, Simone; Amato, Arnaldo; Ardizzone, Sandro; Guidi, Luisa; Danese, Silvio; Massella, Arianna; Ventra, Agostino; Rizzuto, Giulia; Massari, Alessandro; Perri, Francesco; Annese, Vito.

In: Inflammatory Bowel Diseases, Vol. 25, No. 3, 01.08.2018, p. 568-579.

Research output: Contribution to journalArticle

Armuzzi, A, Fiorino, G, Variola, A, Manetti, N, Fries, W, Orlando, A, Maconi, G, Bossa, F, Cappello, M, Biancone, L, Cantoro, L, Costa, F, D’Incà, R, Lionetti, P, Principi, M, Castiglione, F, Annunziata, ML, Di Sabatino, A, Di Girolamo, M, Terpin, MM, Cortelezzi, CC, Saibeni, S, Amato, A, Ardizzone, S, Guidi, L, Danese, S, Massella, A, Ventra, A, Rizzuto, G, Massari, A, Perri, F & Annese, V 2018, 'The PROSIT Cohort of Infliximab Biosimilar in IBD: A Prolonged Follow-up on the Effectiveness and Safety Across Italy', Inflammatory Bowel Diseases, vol. 25, no. 3, pp. 568-579. https://doi.org/10.1093/ibd/izy264
Armuzzi, Alessandro ; Fiorino, Gionata ; Variola, Angela ; Manetti, Natalia ; Fries, Walter ; Orlando, Ambrogio ; Maconi, Giovanni ; Bossa, Fabrizio ; Cappello, Maria ; Biancone, Livia ; Cantoro, Laura ; Costa, Francesco ; D’Incà, Renata ; Lionetti, Paolo ; Principi, Mariabeatrice ; Castiglione, Fabiana ; Annunziata, Maria L ; Di Sabatino, Antonio ; Di Girolamo, Maria ; Terpin, Maria M ; Cortelezzi, Claudio C ; Saibeni, Simone ; Amato, Arnaldo ; Ardizzone, Sandro ; Guidi, Luisa ; Danese, Silvio ; Massella, Arianna ; Ventra, Agostino ; Rizzuto, Giulia ; Massari, Alessandro ; Perri, Francesco ; Annese, Vito. / The PROSIT Cohort of Infliximab Biosimilar in IBD: A Prolonged Follow-up on the Effectiveness and Safety Across Italy. In: Inflammatory Bowel Diseases. 2018 ; Vol. 25, No. 3. pp. 568-579.
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abstract = "We report a prospective, nationwide cohort evaluating the safety and effectiveness of CT-P13.A structured database was used to record serious adverse events (SAEs), clinical remission/response, inflammatory biomarkers (CRP and calprotectin), and endoscopic findings.Eight hundred ten patients with inflammatory bowel disease (IBD) (452 Crohn’s disease [CD]) were enrolled. Four hundred fifty-nine patients were na{\"i}ve to anti-TNFα (group A), 196 had a previous exposure (group B), and the remaining 155 were switched to CT-P13 (group C). All patients were included in the safety evaluation with a mean follow-up of 345 ± 215 days and a total number of 6501 infusions. One hundred fifty-four SAEs were reported (19\, leading to cessation of the biosimilar in 103 subjects (12.7\. Infusion reactions were 71, leading to cessation of the biosimilar in 53 subjects (6.5\, being significantly more frequent in patients pre-exposed to anti-TNFα (P = 0.017). The efficacy of therapy was calculated in 754 IBD patients, with a mean follow-up of 329 ± 202 days. Forty-eight patients had a primary failure (6.4\, and 188 (25.6\ lost response during follow-up. Six hundred twenty-eight (364 CD) and 360 IBD patients (222 CD) completed the follow-up at 6 and 12 months, respectively. At 12 months, patients without loss of response were 71\ 64\ and 82\{\%} in groups A, B, and C, respectively (log rank P = 0.01). Clinical/endoscopic scores and inflammatory biomarkers dropped significantly in CD and UC patients (P = 0.01 and P \lt; 0.0001) compared with baseline.In this large prospective cohort, no further signals of difference in safety and effectiveness of CT-P13 in IBD has been observed.",
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AU - Armuzzi, Alessandro

AU - Fiorino, Gionata

AU - Variola, Angela

AU - Manetti, Natalia

AU - Fries, Walter

AU - Orlando, Ambrogio

AU - Maconi, Giovanni

AU - Bossa, Fabrizio

AU - Cappello, Maria

AU - Biancone, Livia

AU - Cantoro, Laura

AU - Costa, Francesco

AU - D’Incà, Renata

AU - Lionetti, Paolo

AU - Principi, Mariabeatrice

AU - Castiglione, Fabiana

AU - Annunziata, Maria L

AU - Di Sabatino, Antonio

AU - Di Girolamo, Maria

AU - Terpin, Maria M

AU - Cortelezzi, Claudio C

AU - Saibeni, Simone

AU - Amato, Arnaldo

AU - Ardizzone, Sandro

AU - Guidi, Luisa

AU - Danese, Silvio

AU - Massella, Arianna

AU - Ventra, Agostino

AU - Rizzuto, Giulia

AU - Massari, Alessandro

AU - Perri, Francesco

AU - Annese, Vito

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N2 - We report a prospective, nationwide cohort evaluating the safety and effectiveness of CT-P13.A structured database was used to record serious adverse events (SAEs), clinical remission/response, inflammatory biomarkers (CRP and calprotectin), and endoscopic findings.Eight hundred ten patients with inflammatory bowel disease (IBD) (452 Crohn’s disease [CD]) were enrolled. Four hundred fifty-nine patients were naïve to anti-TNFα (group A), 196 had a previous exposure (group B), and the remaining 155 were switched to CT-P13 (group C). All patients were included in the safety evaluation with a mean follow-up of 345 ± 215 days and a total number of 6501 infusions. One hundred fifty-four SAEs were reported (19\, leading to cessation of the biosimilar in 103 subjects (12.7\. Infusion reactions were 71, leading to cessation of the biosimilar in 53 subjects (6.5\, being significantly more frequent in patients pre-exposed to anti-TNFα (P = 0.017). The efficacy of therapy was calculated in 754 IBD patients, with a mean follow-up of 329 ± 202 days. Forty-eight patients had a primary failure (6.4\, and 188 (25.6\ lost response during follow-up. Six hundred twenty-eight (364 CD) and 360 IBD patients (222 CD) completed the follow-up at 6 and 12 months, respectively. At 12 months, patients without loss of response were 71\ 64\ and 82\% in groups A, B, and C, respectively (log rank P = 0.01). Clinical/endoscopic scores and inflammatory biomarkers dropped significantly in CD and UC patients (P = 0.01 and P \lt; 0.0001) compared with baseline.In this large prospective cohort, no further signals of difference in safety and effectiveness of CT-P13 in IBD has been observed.

AB - We report a prospective, nationwide cohort evaluating the safety and effectiveness of CT-P13.A structured database was used to record serious adverse events (SAEs), clinical remission/response, inflammatory biomarkers (CRP and calprotectin), and endoscopic findings.Eight hundred ten patients with inflammatory bowel disease (IBD) (452 Crohn’s disease [CD]) were enrolled. Four hundred fifty-nine patients were naïve to anti-TNFα (group A), 196 had a previous exposure (group B), and the remaining 155 were switched to CT-P13 (group C). All patients were included in the safety evaluation with a mean follow-up of 345 ± 215 days and a total number of 6501 infusions. One hundred fifty-four SAEs were reported (19\, leading to cessation of the biosimilar in 103 subjects (12.7\. Infusion reactions were 71, leading to cessation of the biosimilar in 53 subjects (6.5\, being significantly more frequent in patients pre-exposed to anti-TNFα (P = 0.017). The efficacy of therapy was calculated in 754 IBD patients, with a mean follow-up of 329 ± 202 days. Forty-eight patients had a primary failure (6.4\, and 188 (25.6\ lost response during follow-up. Six hundred twenty-eight (364 CD) and 360 IBD patients (222 CD) completed the follow-up at 6 and 12 months, respectively. At 12 months, patients without loss of response were 71\ 64\ and 82\% in groups A, B, and C, respectively (log rank P = 0.01). Clinical/endoscopic scores and inflammatory biomarkers dropped significantly in CD and UC patients (P = 0.01 and P \lt; 0.0001) compared with baseline.In this large prospective cohort, no further signals of difference in safety and effectiveness of CT-P13 in IBD has been observed.

U2 - 10.1093/ibd/izy264

DO - 10.1093/ibd/izy264

M3 - Articolo

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SP - 568

EP - 579

JO - Inflammatory Bowel Diseases

JF - Inflammatory Bowel Diseases

SN - 1078-0998

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