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. Terpin; Claudio C. Cortelezzi; Simone Saibeni; Arnaldo Amato; Sandro Ardizzone; Luisa Guidi; Silvio Danese; Arianna Massella; Agostino Ventra; Giulia Rizzuto; Alessandro Massari; Francesco Perri; Vito Annese; Silvia Saettone; Roberto Tari; Carlo Petruzzellis; Gianmichele Meucci; Gianni Imperiali; Francesco W. Guglielmi; Silvia Mazzuoli; Luigi Caserta; Maria Caterina Parodi; Agostino Colli; Anna Ronchetti; Daniela Pugliese; Andrea Geccherle; Francesca Rogai; Stefano Milani; Sara Renna; Andrea Cassinotti; Angelo Andriulli; Giuseppina Martino; Barbara Scrivo; Edoardo Troncone; Anna Kohn; Lorenzo Bertani; Greta Lorenzon; Silvia Ghione; Olga Nardone; Maurizio Vecchi; Angela Bertani; Matteo A. Bosani; Cristina Bezzio; Raffaele Salerno

doi:10.1093/ibd/izy264

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, Silvia Saettone, Roberto Tari, Carlo Petruzzellis, Gianmichele Meucci, Gianni Imperiali, Francesco W. Guglielmi, Silvia Mazzuoli, Luigi Caserta, Maria Caterina Parodi, Agostino Colli, Anna Ronchetti, Daniela Pugliese, Andrea Geccherle, Francesca Rogai, Stefano Milani, Sara Renna, Andrea Cassinotti, Angelo Andriulli, Giuseppina Martino, Barbara Scrivo, Edoardo Troncone, Anna Kohn, Lorenzo Bertani, Greta Lorenzon, Silvia Ghione, Olga Nardone, Maurizio Vecchi, Angela Bertani, Matteo A. Bosani, Cristina Bezzio, Raffaele Salerno

Università Cattolica del Sacro Cuore

Research output: Contribution to journal › Article

25 Citations (Scopus)

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 language	English
Pages (from-to)	568-579
Number of pages	12
Journal	Inflammatory Bowel Diseases
Volume	25
DOIs	https://doi.org/10.1093/ibd/izy264
Publication status	Published - 2019

Keywords

Adolescent
Adult
Antibodies, Monoclonal
Biosimilar
CT-P13
Crohn's disease
Female
Follow-Up Studies
Gastrointestinal Agents
Humans
Inflammatory Bowel Diseases
Inflammatory bowel disease
Inflectra
Infliximab
Italy
Male
Prognosis
Prospective Studies
Remsima
Ulcerative colitis
Young Adult

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10.1093/ibd/izy264

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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, M. L., Di Sabatino, A., Di Girolamo, M., ... Salerno, R. (2019). The PROSit cohort of infliximab biosimilar in IBD: A prolonged follow-up on the effectiveness and safety across Italy. Inflammatory Bowel Diseases, 25, 568-579. https://doi.org/10.1093/ibd/izy264

@article{194690f0673e479c86a778e1f0a873d9,

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.",

keywords = "Adolescent, Adult, Antibodies, Monoclonal, Biosimilar, CT-P13, Crohn's disease, Female, Follow-Up Studies, Gastrointestinal Agents, Humans, Inflammatory Bowel Diseases, Inflammatory bowel disease, Inflectra, Infliximab, Italy, Male, Prognosis, Prospective Studies, Remsima, Ulcerative colitis, Young Adult, Adolescent, Adult, Antibodies, Monoclonal, Biosimilar, CT-P13, Crohn's disease, Female, Follow-Up Studies, Gastrointestinal Agents, Humans, Inflammatory Bowel Diseases, Inflammatory bowel disease, Inflectra, Infliximab, Italy, Male, Prognosis, Prospective Studies, Remsima, Ulcerative colitis, Young Adult",

author = "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 and Silvia Saettone and Roberto Tari and Carlo Petruzzellis and Gianmichele Meucci and Gianni Imperiali and Guglielmi, {Francesco W.} and Silvia Mazzuoli and Luigi Caserta and Parodi, {Maria Caterina} and Agostino Colli and Anna Ronchetti and Daniela Pugliese and Andrea Geccherle and Francesca Rogai and Stefano Milani and Sara Renna and Andrea Cassinotti and Angelo Andriulli and Giuseppina Martino and Barbara Scrivo and Edoardo Troncone and Anna Kohn and Lorenzo Bertani and Greta Lorenzon and Silvia Ghione and Olga Nardone and Maurizio Vecchi and Angela Bertani and Bosani, {Matteo A.} and Cristina Bezzio and Raffaele Salerno",

year = "2019",

doi = "10.1093/ibd/izy264",

language = "English",

volume = "25",

pages = "568--579",

journal = "Inflammatory Bowel Diseases",

issn = "1078-0998",

publisher = "Lippincott, Williams & Wilkins:530 Walnut Street:Philadelphia, PA 19106:(800)638-3030, (301)223-2300, EMAIL: orders@lww.com, INTERNET: http://www.lww.com, Fax: (301)223-2320, (301)223-2320",

}

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, Saettone, S, Tari, R, Petruzzellis, C, Meucci, G, Imperiali, G, Guglielmi, FW, Mazzuoli, S, Caserta, L, Parodi, MC, Colli, A, Ronchetti, A, Pugliese, D, Geccherle, A, Rogai, F, Milani, S, Renna, S, Cassinotti, A, Andriulli, A, Martino, G, Scrivo, B, Troncone, E, Kohn, A, Bertani, L, Lorenzon, G, Ghione, S, Nardone, O, Vecchi, M, Bertani, A, Bosani, MA, Bezzio, C & Salerno, R 2019, 'The PROSit cohort of infliximab biosimilar in IBD: A prolonged follow-up on the effectiveness and safety across Italy', Inflammatory Bowel Diseases, vol. 25, pp. 568-579. https://doi.org/10.1093/ibd/izy264

TY - JOUR

T1 - The PROSit cohort of infliximab biosimilar in IBD: A prolonged follow-up on the effectiveness and safety across Italy

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

AU - Saettone, Silvia

AU - Tari, Roberto

AU - Petruzzellis, Carlo

AU - Meucci, Gianmichele

AU - Imperiali, Gianni

AU - Guglielmi, Francesco W.

AU - Mazzuoli, Silvia

AU - Caserta, Luigi

AU - Parodi, Maria Caterina

AU - Colli, Agostino

AU - Ronchetti, Anna

AU - Pugliese, Daniela

AU - Geccherle, Andrea

AU - Rogai, Francesca

AU - Milani, Stefano

AU - Renna, Sara

AU - Cassinotti, Andrea

AU - Andriulli, Angelo

AU - Martino, Giuseppina

AU - Scrivo, Barbara

AU - Troncone, Edoardo

AU - Kohn, Anna

AU - Bertani, Lorenzo

AU - Lorenzon, Greta

AU - Ghione, Silvia

AU - Nardone, Olga

AU - Vecchi, Maurizio

AU - Bertani, Angela

AU - Bosani, Matteo A.

AU - Bezzio, Cristina

AU - Salerno, Raffaele

PY - 2019

Y1 - 2019

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.

KW - Adolescent

KW - Adult

KW - Antibodies, Monoclonal

KW - Biosimilar

KW - CT-P13

KW - Crohn's disease

KW - Female

KW - Follow-Up Studies

KW - Gastrointestinal Agents

KW - Humans

KW - Inflammatory Bowel Diseases

KW - Inflammatory bowel disease

KW - Inflectra

KW - Infliximab

KW - Italy

KW - Male

KW - Prognosis

KW - Prospective Studies

KW - Remsima

KW - Ulcerative colitis

KW - Young Adult

KW - Adolescent

KW - Adult

KW - Antibodies, Monoclonal

KW - Biosimilar

KW - CT-P13

KW - Crohn's disease

KW - Female

KW - Follow-Up Studies

KW - Gastrointestinal Agents

KW - Humans

KW - Inflammatory Bowel Diseases

KW - Inflammatory bowel disease

KW - Inflectra

KW - Infliximab

KW - Italy

KW - Male

KW - Prognosis

KW - Prospective Studies

KW - Remsima

KW - Ulcerative colitis

KW - Young Adult

UR - http://hdl.handle.net/10807/155054

U2 - 10.1093/ibd/izy264

DO - 10.1093/ibd/izy264

M3 - Article

SN - 1078-0998

VL - 25

SP - 568

EP - 579

JO - Inflammatory Bowel Diseases

JF - Inflammatory Bowel Diseases

ER -

The PROSit cohort of infliximab biosimilar in IBD: A prolonged follow-up on the effectiveness and safety across Italy

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