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 |
|---|---|
| Journal | Inflammatory Bowel Diseases |
| DOIs | |
| Publication status | E-pub ahead of print - Aug 18 2018 |
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The PROSIT Cohort of Infliximab Biosimilar in IBD : A Prolonged Follow-up on the Effectiveness and Safety Across Italy. / PROSIT Investigators .
In: Inflammatory Bowel Diseases, 18.08.2018.Research output: Contribution to journal › Article
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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 -