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.

The PROSIT-BIO Cohort: A Prospective Observational Study of Patients with Inflammatory Bowel Disease Treated with Infliximab Biosimilar / G. Fiorino, N. Manetti, A. Armuzzi, A. Orlando, A. Variola, S. Bonovas, F. Bossa, G. Maconi, R. D'Incà, P. Lionetti, L. Cantoro, W. Fries, M.L. Annunziata, F. Costa, M.M. Terpin, L. Biancone, C.C. Cortelezzi, A. Amato, S. Ardizzone, S. Danese, L. Guidi, G. Rizzuto, A. Massella, A. Andriulli, A. Massari, G. Lorenzon, S. Ghione, A. Kohn, A. Ventra, V. Annese, M. Principi, M. Di Girolamo, A. Bertani, S. Saettone, R. Tari, C. Petruzzellis, F.W. Guglielmi, S. Mazzuoli, M. Cappello, A. Viola, F. Castiglione, O. Nardone, A. Di Sabatino, S. Saibeni, C. Bezzio, L. Caserta, M.C. Parodi, G. Meucci, A. Colli, A. Ronchetti, M. Vecchi, L. Bertani, M.A. Bosani, E. Tronconi, G. Imperiali, R. Salerno, F. Rogai, S. Milani, D. Pugliese, S. Renna, A. Geccherle, G. Martino, A. Cassinotti. - In: INFLAMMATORY BOWEL DISEASES. - ISSN 1078-0998. - 23:2(2017 Feb), pp. 233-243. [10.1097/MIB.0000000000000995]

The PROSIT-BIO Cohort: A Prospective Observational Study of Patients with Inflammatory Bowel Disease Treated with Infliximab Biosimilar

S. Bonovas;G. Maconi;S. Ardizzone;A. Massari;A. Viola;S. Saibeni;C. Bezzio;M. Vecchi;M.A. Bosani;S. Milani;A. Cassinotti
2017-02

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.
Crohn's disease; ulcerative colitis; inflammatory bowel disease; Infliximab; Remsima; Inflectra; biosimilar; CT-P13
Settore MED/12 - Gastroenterologia
Article (author)
File in questo prodotto:
File Dimensione Formato  
ibd00233.pdf

accesso riservato

Tipologia: Publisher's version/PDF
Dimensione 300.58 kB
Formato Adobe PDF
300.58 kB Adobe PDF   Visualizza/Apri   Richiedi una copia
Pubblicazioni consigliate

Caricamento pubblicazioni consigliate

I documenti in IRIS sono protetti da copyright e tutti i diritti sono riservati, salvo diversa indicazione.

Utilizza questo identificativo per citare o creare un link a questo documento: http://hdl.handle.net/2434/641177
Citazioni
  • ???jsp.display-item.citation.pmc??? 31
  • Scopus 107
  • ???jsp.display-item.citation.isi??? 105
social impact