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Monday 23 April 2018
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Biosimilar infliximab is comparable to reference product and adalimumab in highly anticipated real-world study

Twelve-month data from the Personalised Anti-TNF therapy in Crohn’s disease Study (PANTS) was presented at the 13th Congress of the European Crohn’s and Colitis Organisation (ECCO).

 

The results indicate that the clinical effectiveness, safety and immunogenicity of Pfizer and Celltrion Healthcare’s CT-P13 (biosimilar infliximab) in patients with Crohn’s disease (CD) is comparable to those treated with reference infliximab as well as those treated with adalimumab.1

 

The UK-wide, three-year prospective observational study investigated primary non-response (PNR), loss of response (LOR) and adverse drug reactions (ADR) to infliximab (reference infliximab and CT-P13) and adalimumab in 1610 CD patients. The data show comparable efficacy between CT-P13, reference infliximab and adalimumab in relation to PNR, LOR and ADR rates. In addition, at week 54, the remission rate was 39.7%, 39.0% and 32.7% for reference infliximab, CT-P13 and adalimumab treated patients, respectively.1

 

The PANTS study investigates patient, drug and pharmacokinetic factors that predict anti-TNF treatment failure with the aim of developing personalised anti-TNF strategies to improve patient outcomes. This large real-world prospective cohort study provides valuable data on clinical effectiveness as well as biologic samples for genomic studies.1

 

PANTS study investigator Dr Tariq Ahmad, Head of the Inflammatory Bowel Disease and Pharmacogenetics Research Group at the University of Exeter, and Consultant Gastroenterologist at the Royal Devon and Exeter Hospital UK said, “We strongly believe that this type of research is essential to developing cost effective, treatment strategies for patients with inflammatory bowel disease in order to maximise benefit. The results from PANTS suggest there are opportunities to optimise the management of anti-TNF therapies and to prevent treatment failure.”

 

According to the study, immunogenicity is a significant factor in non-remission for both infliximab and adalimumab treated patients at week 54 but can be mitigated by the use of immunomodulators - azathioprine, mercaptopurine and methotrexate. The PANTS study has demonstrated that this risk is in part genetically determined and as such personalised treatment algorithms may be developed in the future.1

 

Man Hoon Kim, President and CEO of Celltrion Healthcare, said, “The PANTS results clearly show that the  careful optimisation of CT-P13, reference infliximab and adalimumab as part of routine care may make these treatments more effective for patients with inflammatory bowel disease. Therefore, given the significant cost savings in using CT-P13, this treatment has the potential to play a huge role in increasing patient access to biological treatment and improving outcomes.”

 

Our mission at Celltrion Healthcare is to improve quality of care and expand access to new and effective treatments for patients around the world. We believe dose optimisation is a key component to fulfilling this and therefore we are investing in innovations such as pharmacokinetic monitoring kits, to help ensure that more patients have access to personalised treatment.”

 

Reference

  1. Kennedy NA et al. Clinical effectiveness, safety and immunogenicity of anti-TNF therapy in Crohn’s Disease: 12 month data from the PANTS study Congress of the European Crohn’s and Colitis Organisation (ECCO) 2018. OP031

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