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Clinical trial evidence in IBD

INFLECTRA®/CT-P13 (infliximab): clinical trial evidence in IBD

Use of CT-P13 (infliximab) in CD and UC is supported by a rapidly growing body of clinical evidence and experience5-18

All published studies, reports and study abstracts evaluating CT-P13 (infliximab) in IBD identified through April 2017.‡§

**Some real-world cases have not reported comparable results when switching from originator to biosimilars.

Learn about two of our important clinical trials.

Study 3.4 overview

NOR-SWITCH overview

*CT-P13 was designed with comparable efficacy, safety and quality to reference infliximab, to increase the treatment options for your Crohn’s disease and ulcerative colitis patients.20,21 Increasing real-world experience confirms the CT-P13 clinical efficacy and safety profile.22

†CT-P13 is marketed under different brand names including INFLECTRA® and REMSIMA™.

‡Data for Study 3.4 were acquired from an abstract presented at UEGW in October 2017.

§Not all studies evaluated the efficacy and/or safety of CT-P13. The majority of studies were either retrospective or prospective/observational, and in most cases, CT-P13 results were compared against baseline parameters or prior evidence of Remicade™.

 

CD, Crohn’s disease; ECCO, European Crohn’s and Colitis Organisation; IBD, Inflammatory bowel disease; RCT, Randomised controlled trial; UC, Ulcerative colitis.

 

 

Šaltiniai: 

1. Gecse KB, et al. J Crohns Colitis 2016;10(2):133-40. 2. Jørgensen KK, et al. Lancet 2017;389:2304-16. 3. QuintilesIMS. MIDAS, February 2017. 4. INFLECTRA® Summary of Product Characteristics. 5. Kim YH, et al. Abstract LB04, UEGW 2017. United European Gastroenterol J 2017;5:1139-40. 6. Jørgensen KK, et al. Lancet 2017;389:2304-16. 7. Fiorino G, et al. Inflamm Bowel Dis 2017;23:233-43. 8. Gecse KB, et al. J Crohns Colitis 2016;10(2):133-40. 9. Abstracts of ECCO 2017. J Crohns Colitis 2017;11/Supp 1 [Alfonso J, et al. P248. Ametzazurra A, et al. P503. Choe YH, et al. P487. Choe YH, et al. P500. Curdia Goncalves T, et al. P472. Eberl A, et al. P639. Fiorino G, et al. P605. Fiorino G, et al. P633. Gompertz M, et al. P679. Gonzalez A, et al. P508. Guerrero Puente LN, et al. P545. Han S, et al. P582. Huoponen S, et al. P685. Juan G, et al. P632. Kang B, et al. P542. Kaniewska M, et al. P425. Kolar M, et al. P532. Lovasz BD, et al. P592. Molnar T, et al. P675. Mortier K, et al. P333. Nugent S, et al. P430. Plevris N, et al. P586. Rodriguez Glez GE, et al. P629. Sladek M, et al. P661. Smits L, et al. P663. Soret PA, et al. P471. Strik A, et al. P665. St. Clair Jones A, et al. P527.]. 10. Abstracts of ECCO 2016. J Crohns Colitis 2016;10/Supp 1 [Bortlik M, et al. P495. Carvalho L, et al. P327; Diaz Hernández L, et al. P449. Guerra Veloz MF, et al. P452; Guerra Veloz MF, et al. P600; Hamanaka S, et al. P329. Kaniewska M, Rydzewska G. P645. Kolar M, et al. DOP032. Muhammed R, et al. P382. Sieczkowska J, et al. P530. Turk N, et al. P577. Zagorowicz E, et al. P513.].
11. Abstracts of BSG 2016. Gut 2016;7/Supp 1 [Ala K, et al. PTU-059; Bennett KJ, et al. PWE-017; Chung L, et al. OC-038; Rahmany S, et al. PTU-073.]. 12. Farkas K, et al. J Crohns Colitis 2016;10:1273-8. 13. Hlavaty T, et al. Gastroenterol Hepatol 2016;70:27-32. 14. Jahnsen J, et al. Expert Rev Gastroenterol Hepatol 2015;9(S1):S45-52. 15. Keil R, et al. Scand J Gastroenterol 2016;51:1062-8. 16. UK inflammatory bowel disease (IBD) programme steering group. Royal College of Physicians, UK. IBD Biological Therapy Audit 2016. Available at: https://www.rcplondon.ac.uk/projects/outputs/national-clinical-audit-bio.... Accessed December 2017. 17. Razanskaite V, et al. J Crohns Colitis 2017 Jan 27 epub. 18. Smits LJ, et al. J Crohns Colitis 2016;10:1287-93. 19. ClinicalTrials.gov. NCT02096861. Available at: https://clinicaltrials.gov/ct2/show/NCT02096861?term=CT-P13&rank=1. Accessed December 2017. 20. European Public Assessment Report: INFLECTRA™. Available at: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Public_asses.... Accessed December 2017. 21. European Medicines Agency. Guidelines on similar biological medicinal products containing monoclonal antibodies - non-clinical and clinical issues. Available at: http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/ 2012/06/WC500128686.pdf. Accessed December 2017. 22. Danese S, et al. J Crohns Colitis 2017;11:26-34.

 

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