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NOR-SWITCH study overview

NOR-SWITCH is the first RCT evaluating the effect of switching from Remicade™† (infliximab) to INFLECTRA®/CT-P13 (infliximab)2
 

NOR-SWITCH study design
 

No inferiority§ in disease worsening

  • Stable patients switching to CT-P13 experienced no difference in disease worsening across all indications than those remaining on Remicade™ (infliximab) therapy#2

Disease worsening at Week 52¶2

Per-protocol set population. Primary endpoint. Created from Jørgensen KK, et al. 2017

 

  • There was a similar adverse event profile in stable patients switching from Remicade™ (infliximab) to CT-P13 compared to those remaining on Remicade™ (infliximab) therapy2

 

Treatment-emergent adverse events2

Safety population. Created from Jørgensen KK, et al. 2017.

 

 

*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.5,6 Increasing real-world experience confirms the CT-P13 clinical efficacy and safety profile.7

†Remicade is a registered trademark of MSD.

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

§According to a prespecified margin of 15%. The study was not powered to show non-inferiority in individual diseases.

#Only single one-way switching from Remicade™ to CT-P13 was examined in this study.
 ¶The NOR-SWITCH trial included only patients on Remicade™ and CT-P13; its findings do not support that any other biosimilars of infliximab can achieve the same result.

 

CI, Confidence interval; ECCO, European Crohn’s and Colitis Organisation; IBD, Inflammatory bowel disease; RCT, Randomised controlled trial.

 

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. European Public Assessment Report: INFLECTRA™. Available at: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Public_asses.... Accessed December 2017. 6. 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. 7. Danese S, et al. J Crohns Colitis 2017;11:26-34.

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