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.

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

Bertani L.;
2019-01-01

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.
2019
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'Inca, R.; Lionetti, P.; Principi, M.; Castiglione, F.; Annunziata, M. L.; Di Sabatino, A.; Di Girolamo, M.; Terpin, M. M.; Cortelezzi, C. C.; 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, F. W.; Mazzuoli, S.; Caserta, L.; Parodi, M. C.; 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, M. A.; Bezzio, C.; Salerno, R.
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Utilizza questo identificativo per citare o creare un link a questo documento: https://hdl.handle.net/11568/1054232
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