The PROSIT Cohort of Infliximab Biosimilar in IBD

A Prolonged Follow-up on the Effectiveness and Safety Across Italy

PROSIT Investigators

Research output: Contribution to journalArticle

Abstract

Background: We report a prospective, nationwide cohort evaluating the safety and effectiveness of CT-P13.

Methods: A structured database was used to record serious adverse events (SAEs), clinical remission/response, inflammatory biomarkers (CRP and calprotectin), and endoscopic findings.

Results: 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 < 0.0001) compared with baseline.

Conclusions: In this large prospective cohort, no further signals of difference in safety and effectiveness of CT-P13 in IBD has been observed.

Original languageEnglish
JournalInflammatory Bowel Diseases
DOIs
Publication statusE-pub ahead of print - Aug 18 2018

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Biosimilar Pharmaceuticals
Inflammatory Bowel Diseases
Italy
Safety
Crohn Disease
Biomarkers
Leukocyte L1 Antigen Complex
Infliximab

Cite this

@article{9dc0515568f3490fa45f989b47f2566b,
title = "The PROSIT Cohort of Infliximab Biosimilar in IBD: A Prolonged Follow-up on the Effectiveness and Safety Across Italy",
abstract = "Background: We report a prospective, nationwide cohort evaluating the safety and effectiveness of CT-P13.Methods: A structured database was used to record serious adverse events (SAEs), clinical remission/response, inflammatory biomarkers (CRP and calprotectin), and endoscopic findings.Results: 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 < 0.0001) compared with baseline.Conclusions: In this large prospective cohort, no further signals of difference in safety and effectiveness of CT-P13 in IBD has been observed.",
author = "{PROSIT Investigators} and Alessandro Armuzzi and Gionata Fiorino and Angela Variola and Natalia Manetti and Walter Fries and Ambrogio Orlando and Giovanni Maconi and Fabrizio Bossa and Maria Cappello and Livia Biancone and Laura Cantoro and Francesco Costa and Renata D'Inc{\`a} and Paolo Lionetti and Mariabeatrice Principi and Fabiana Castiglione and Annunziata, {Maria L} and {Di Sabatino}, Antonio and {Di Girolamo}, Maria and Terpin, {Maria M} and Cortelezzi, {Claudio C} and Simone Saibeni and Arnaldo Amato and Sandro Ardizzone and Luisa Guidi and Silvio Danese and Arianna Massella and Agostino Ventra and Giulia Rizzuto and Alessandro Massari and Francesco Perri and Vito Annese",
year = "2018",
month = "8",
day = "18",
doi = "10.1093/ibd/izy264",
language = "English",
journal = "Inflammatory Bowel Diseases",
issn = "1078-0998",
publisher = "Oxford University Press",

}

TY - JOUR

T1 - The PROSIT Cohort of Infliximab Biosimilar in IBD

T2 - A Prolonged Follow-up on the Effectiveness and Safety Across Italy

AU - PROSIT Investigators

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

PY - 2018/8/18

Y1 - 2018/8/18

N2 - Background: We report a prospective, nationwide cohort evaluating the safety and effectiveness of CT-P13.Methods: A structured database was used to record serious adverse events (SAEs), clinical remission/response, inflammatory biomarkers (CRP and calprotectin), and endoscopic findings.Results: 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 < 0.0001) compared with baseline.Conclusions: In this large prospective cohort, no further signals of difference in safety and effectiveness of CT-P13 in IBD has been observed.

AB - Background: We report a prospective, nationwide cohort evaluating the safety and effectiveness of CT-P13.Methods: A structured database was used to record serious adverse events (SAEs), clinical remission/response, inflammatory biomarkers (CRP and calprotectin), and endoscopic findings.Results: 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 < 0.0001) compared with baseline.Conclusions: 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 - Article

JO - Inflammatory Bowel Diseases

JF - Inflammatory Bowel Diseases

SN - 1078-0998

ER -