Abstract
Background: Few data are available on the safety and efficacy of infliximab biosimilar CT-P13 in patients with ulcerative colitis and Crohn's disease. Methods: A prospective, multicenter, cohort study using a structured database. Results: Consecutive patients (313 Crohn's disease and 234 ulcerative colitis) were enrolled from 31 referral centers; 311 patients were naive to anti-tumor necrosis factor alpha, 139 had a previous exposure to biologics, and the remaining 97 were switched to CT-P13 after a mean of 18 ± 14 infusions of infliximab. The mean follow-up was 4.3 ± 2.8 months, and the total follow-up time was 195 patient-years. After 2061 infusions, 66 serious adverse events were reported (12.1%), 38 (6.9%) of them were infusion-related reactions. The biosimilar had to be stopped in 29 (5.3%) cases for severe infusion reactions (8 naive, 19 previous exposed, and 2 switch), and in further 16 patients (2.9%) for other serious adverse events. Infusion reactions were significantly more frequent in patients pre-exposed to infliximab than to other anti-tumor necrosis factor alpha (incidence rate ratio = 2.82, 95% CI: 1.05-7.9). The efficacy of the biosimilar was evaluated in 434 patients who received treatment for at least 8 weeks, using time-to-event methods for censored observations: 35 patients were primary failures (8.1%). After further 8, 16, and 24 weeks, the efficacy estimations were 95.7%, 86.4%, and 73.7% for naive, 97.2%, 85.2%, and 62.2% for pre-exposed, and 94.5%, 90.8%, and 78.9% for switch, respectively (log-rank P = 0.64). Conclusions: Although no direct comparison was performed, preliminary data on efficacy and safety of CT-P13 were in line with those of infliximab.
| Original language | English |
|---|---|
| Pages (from-to) | 233-243 |
| Number of pages | 11 |
| Journal | Inflammatory Bowel Diseases |
| Volume | 23 |
| Issue number | 2 |
| DOIs | |
| Publication status | Published - Feb 1 2017 |
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Keywords
- biosimilar
- Crohn's disease
- CT-P13
- inflammatory bowel disease
- Inflectra
- Infliximab
- Remsima
- ulcerative colitis
ASJC Scopus subject areas
- Immunology and Allergy
- Gastroenterology
Cite this
The PROSIT-BIO Cohort : A Prospective Observational Study of Patients with Inflammatory Bowel Disease Treated with Infliximab Biosimilar. / Fiorino, Gionata; Manetti, Natalia; Armuzzi, Alessandro; Orlando, Ambrogio; Variola, Angela; Bonovas, Stefanos; Bossa, Fabrizio; Maconi, Giovanni; D'Incà, Renata; Lionetti, Paolo; Cantoro, Laura; Fries, Walter; Annunziata, Maria L.; Costa, Francesco; Terpin, Maria M.; Biancone, Livia; Cortelezzi, Claudio C.; Amato, Arnaldo; Ardizzone, Sandro; Danese, Silvio; Guidi, Luisa; Rizzuto, Giulia; Massella, Arianna; Andriulli, Angelo; Massari, Alessandro; Lorenzon, Greta; Ghione, Silvia; Kohn, Anna; Ventra, Agostino; Annese, Vito; Principi, Mariabeatrice; Di Girolamo, Maria; Bertani, Angela; Saettone, Silvia; Tari, Roberto; Petruzzellis, Carlo; Guglielmi, Francesco W.; Mazzuoli, Silvia; Cappello, Maria; Viola, Anna; Castiglione, Fabiana; Nardone, Olga; Di Sabatino, Antonio; Saibeni, Simone; Bezzio, Cristina; Caserta, Luigi; Parodi, Maria Caterina; Meucci, Gianmichele; Ronchetti, Anna; Vecchi, Maurizio; The PROSIT-BIO Cohort.
In: Inflammatory Bowel Diseases, Vol. 23, No. 2, 01.02.2017, p. 233-243.Research output: Contribution to journal › Article
}
TY - JOUR
T1 - The PROSIT-BIO Cohort
T2 - A Prospective Observational Study of Patients with Inflammatory Bowel Disease Treated with Infliximab Biosimilar
AU - Fiorino, Gionata
AU - Manetti, Natalia
AU - Armuzzi, Alessandro
AU - Orlando, Ambrogio
AU - Variola, Angela
AU - Bonovas, Stefanos
AU - Bossa, Fabrizio
AU - Maconi, Giovanni
AU - D'Incà, Renata
AU - Lionetti, Paolo
AU - Cantoro, Laura
AU - Fries, Walter
AU - Annunziata, Maria L.
AU - Costa, Francesco
AU - Terpin, Maria M.
AU - Biancone, Livia
AU - Cortelezzi, Claudio C.
AU - Amato, Arnaldo
AU - Ardizzone, Sandro
AU - Danese, Silvio
AU - Guidi, Luisa
AU - Rizzuto, Giulia
AU - Massella, Arianna
AU - Andriulli, Angelo
AU - Massari, Alessandro
AU - Lorenzon, Greta
AU - Ghione, Silvia
AU - Kohn, Anna
AU - Ventra, Agostino
AU - Annese, Vito
AU - Principi, Mariabeatrice
AU - Di Girolamo, Maria
AU - Bertani, Angela
AU - Saettone, Silvia
AU - Tari, Roberto
AU - Petruzzellis, Carlo
AU - Guglielmi, Francesco W.
AU - Mazzuoli, Silvia
AU - Cappello, Maria
AU - Viola, Anna
AU - Castiglione, Fabiana
AU - Nardone, Olga
AU - Di Sabatino, Antonio
AU - Saibeni, Simone
AU - Bezzio, Cristina
AU - Caserta, Luigi
AU - Parodi, Maria Caterina
AU - Meucci, Gianmichele
AU - Ronchetti, Anna
AU - Vecchi, Maurizio
AU - The PROSIT-BIO Cohort
PY - 2017/2/1
Y1 - 2017/2/1
N2 - Background: Few data are available on the safety and efficacy of infliximab biosimilar CT-P13 in patients with ulcerative colitis and Crohn's disease. Methods: A prospective, multicenter, cohort study using a structured database. Results: Consecutive patients (313 Crohn's disease and 234 ulcerative colitis) were enrolled from 31 referral centers; 311 patients were naive to anti-tumor necrosis factor alpha, 139 had a previous exposure to biologics, and the remaining 97 were switched to CT-P13 after a mean of 18 ± 14 infusions of infliximab. The mean follow-up was 4.3 ± 2.8 months, and the total follow-up time was 195 patient-years. After 2061 infusions, 66 serious adverse events were reported (12.1%), 38 (6.9%) of them were infusion-related reactions. The biosimilar had to be stopped in 29 (5.3%) cases for severe infusion reactions (8 naive, 19 previous exposed, and 2 switch), and in further 16 patients (2.9%) for other serious adverse events. Infusion reactions were significantly more frequent in patients pre-exposed to infliximab than to other anti-tumor necrosis factor alpha (incidence rate ratio = 2.82, 95% CI: 1.05-7.9). The efficacy of the biosimilar was evaluated in 434 patients who received treatment for at least 8 weeks, using time-to-event methods for censored observations: 35 patients were primary failures (8.1%). After further 8, 16, and 24 weeks, the efficacy estimations were 95.7%, 86.4%, and 73.7% for naive, 97.2%, 85.2%, and 62.2% for pre-exposed, and 94.5%, 90.8%, and 78.9% for switch, respectively (log-rank P = 0.64). Conclusions: Although no direct comparison was performed, preliminary data on efficacy and safety of CT-P13 were in line with those of infliximab.
AB - Background: Few data are available on the safety and efficacy of infliximab biosimilar CT-P13 in patients with ulcerative colitis and Crohn's disease. Methods: A prospective, multicenter, cohort study using a structured database. Results: Consecutive patients (313 Crohn's disease and 234 ulcerative colitis) were enrolled from 31 referral centers; 311 patients were naive to anti-tumor necrosis factor alpha, 139 had a previous exposure to biologics, and the remaining 97 were switched to CT-P13 after a mean of 18 ± 14 infusions of infliximab. The mean follow-up was 4.3 ± 2.8 months, and the total follow-up time was 195 patient-years. After 2061 infusions, 66 serious adverse events were reported (12.1%), 38 (6.9%) of them were infusion-related reactions. The biosimilar had to be stopped in 29 (5.3%) cases for severe infusion reactions (8 naive, 19 previous exposed, and 2 switch), and in further 16 patients (2.9%) for other serious adverse events. Infusion reactions were significantly more frequent in patients pre-exposed to infliximab than to other anti-tumor necrosis factor alpha (incidence rate ratio = 2.82, 95% CI: 1.05-7.9). The efficacy of the biosimilar was evaluated in 434 patients who received treatment for at least 8 weeks, using time-to-event methods for censored observations: 35 patients were primary failures (8.1%). After further 8, 16, and 24 weeks, the efficacy estimations were 95.7%, 86.4%, and 73.7% for naive, 97.2%, 85.2%, and 62.2% for pre-exposed, and 94.5%, 90.8%, and 78.9% for switch, respectively (log-rank P = 0.64). Conclusions: Although no direct comparison was performed, preliminary data on efficacy and safety of CT-P13 were in line with those of infliximab.
KW - biosimilar
KW - Crohn's disease
KW - CT-P13
KW - inflammatory bowel disease
KW - Inflectra
KW - Infliximab
KW - Remsima
KW - ulcerative colitis
UR - http://www.scopus.com/inward/record.url?scp=85010905756&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85010905756&partnerID=8YFLogxK
U2 - 10.1097/MIB.0000000000000995
DO - 10.1097/MIB.0000000000000995
M3 - Article
AN - SCOPUS:85010905756
VL - 23
SP - 233
EP - 243
JO - Inflammatory Bowel Diseases
JF - Inflammatory Bowel Diseases
SN - 1078-0998
IS - 2
ER -