scholarly journals Safety and clinical efficacy of the double switch from originator infliximab to biosimilars CT‐P13 and SB2 in patients with inflammatory bowel diseases (SCESICS): A multicenter cohort study

2021 ◽  
Author(s):  
Stefano Mazza ◽  
Nicole Piazza O. Sed ◽  
Francesco Simone Conforti ◽  
Alberto Fascì ◽  
Alessandro Rimondi ◽  
...  
Keyword(s):  
Cohort Study ◽  
Clinical Efficacy ◽  
Inflammatory Bowel Diseases ◽  
Multicenter Cohort Study ◽  
Multicenter Cohort ◽  
Bowel Diseases ◽  
Inflammatory Bowel ◽  
Double Switch

scholarly journals Tolerability of one hour 10mg/kg infliximab infusions in inflammatory bowel diseases: A prospective multicenter cohort study

2014 ◽  
Vol 8 (2) ◽  
pp. 161-165 ◽  
Author(s):  
Abdenour Babouri ◽  
Xavier Roblin ◽  
Jérôme Filippi ◽  
Xavier Hébuterne ◽  
Marc-André Bigard ◽  
...  
Keyword(s):  
Cohort Study ◽  
Inflammatory Bowel Diseases ◽  
Multicenter Cohort Study ◽  
Multicenter Cohort ◽  
Bowel Diseases ◽  
Inflammatory Bowel

scholarly journals P360 Safety and clinical efficacy of double switch from originator infliximab to biosimilars CT-P13 and SB2 in patients with inflammatory bowel diseases (SCESICS): A multicentre study

2020 ◽  
Vol 14 (Supplement_1) ◽  
pp. S342-S342
Author(s):  
S Mazza ◽  
A Fascì ◽  
V Casini ◽  
C Ricci ◽  
F Munari ◽  
...  
Keyword(s):  
Clinical Efficacy ◽  
Inflammatory Bowel Diseases ◽  
Clinical Remission ◽  
Comparable Efficacy ◽  
Potential Cost ◽  
Safety And Efficacy ◽  
Bowel Diseases ◽  
Inflammatory Bowel ◽  
Double Switch

Abstract Background Since infliximab (IFX) patent expiry in 2015, several IFX biosimilars have been licensed in EU for all indications, including inflammatory bowel diseases (IBD). IFX biosimilars currently available in Italy include CT-P13 and SB2, both of which demonstrated comparable efficacy, safety and immunogenicity with IFX originator in IBD patients. Safety and clinical efficacy of single switch from originator IFX to CT-P13 have also been confirmed in a prospective clinical trial. On the contrary, data regarding multiple therapeutic switching of IFX originator with CT-P13 and SB2 are currently lacking. Methods This study was aimed to evaluate the safety and efficacy of double switch from IFX originator to CT-P13 and subsequently to SB2 in patients with IBD. From November 2018 to May 2019, patients undergoing IFX double switch in 8 Centres in Lombardy were retrospectively analysed. The overall rate of IFX discontinuation, incidence and type of adverse events (AE) and proportion of patients on clinical remission over time were recorded. Data were compared with a control group of 66 IBD patients single switched from IFX originator to CT-P13. Results Fifty-two double-switched IBD patients were enrolled (63% M, mean age 41 years, 75% Crohn’s disease, 25% ulcerative colitis). Main indications for IFX therapy were moderate to severe disease (50%) and steroid-dependent disease (25%). The overall 24- and 48-week IFX discontinuation rates following second switch (CTP13->SB2) were 2% (95% CI 0–6%) and 14% (95% CI 3–25%), respectively. During a median follow-up of 40 weeks (18–48), 4 patients (12%) experienced a total of 6 AE (2 cutaneous, 2 infectious, 1 articular and 1 immunological), leading to IFX discontinuation in 3 cases (6%). No infusion reactions were observed. At week 24 following second switch, 49 (94%) patients were in clinical remission, the remaining 3 patients not being in remission already at the time of second switch. Only one patient lost response after week 24, 48 (92%) of patients being in clinical remission at the end of follow-up. No differences in IFX discontinuation, AE and clinical remission rates were found between double-switched and single-switched patients. No clinical parameters were found to predict safety and efficacy outcomes. Conclusion The study supports both safety and efficacy of the double switch from IFX originator to CT-P13 and SB2 in patients with IBD, and demonstrates its non-inferiority to a single switch strategy, with potential cost implications.

Prevalence and Implications of Frailty in Older Adults with Incident Inflammatory Bowel Diseases: a Nationwide Cohort Study

2022 ◽  
Author(s):  
Bharati Kochar ◽  
Juulia Jylhävä ◽  
Jonas Söderling ◽  
Christine S. Ritchie ◽  
Jonas F. Ludvigsson ◽  
...  
Keyword(s):  
Older Adults ◽  
Cohort Study ◽  
Inflammatory Bowel Diseases ◽  
Bowel Diseases ◽  
Inflammatory Bowel

Idiopathic acute pancreatitis in patients with inflammatory bowel disease: A multicenter cohort study

Pancreatology ◽  
2020 ◽  
Vol 20 (3) ◽  
pp. 331-337 ◽  
Author(s):  
Ana Garcia Garcia de Paredes ◽  
Enrique Rodriguez de Santiago ◽  
Carlos Rodriguez-Escaja ◽  
Marisa Iborra ◽  
Alicia Algaba ◽  
...  
Keyword(s):  
Inflammatory Bowel Disease ◽  
Acute Pancreatitis ◽  
Cohort Study ◽  
Bowel Disease ◽  
Multicenter Cohort Study ◽  
Multicenter Cohort ◽  
Idiopathic Acute Pancreatitis ◽  
Inflammatory Bowel

scholarly journals Risk of intestinal and extra-intestinal cancers in patients with inflammatory bowel diseases: A population-based cohort study in northeastern Italy

PLoS ONE ◽  
2020 ◽  
Vol 15 (6) ◽  
pp. e0235142
Author(s):  
Martina Taborelli ◽  
Michele Sozzi ◽  
Stefania Del Zotto ◽  
Federica Toffolutti ◽  
Marcella Montico ◽  
...  
Keyword(s):  
Cohort Study ◽  
Inflammatory Bowel Diseases ◽  
Population Based ◽  
Bowel Diseases ◽  
Northeastern Italy ◽  
Inflammatory Bowel
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