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Optimising treatment (TDM)

Optimising treatment (Biomarkers)

Therapeutic Drug Monitoring (TDM) and biomarkers such as faecal calprotection (FC) can be useful tools in helping to support clinical decision making to optimise treatment. Treatment optimisation can involve changing the dosing, infusion interval or stopping treatment. 

Please note that Inflectra/infliximab is not licensed for dose escalation in ulcerative colitis, ankylosing spondylitis, psoriasis, psoriatic arthritis, paediatric ulcerative colitis or paediatric Crohn's disease. Inflectra/infliximab is licensed for dose escalation in rheumatoid arthritis and crohn's disease

What is TDM?

TDM is a measurement of serum drug concentrations and anti-drug antibodies (ADA) to allow more accurate adjustments of drug levels in an indiviudal patient.1-3

Figure adapted from Tracy D, et al. 2008.

TDM can provide clinical insight in either:

  • Primary non-response (PNR): lack of improvement in clinical signs and symptoms with induction therapy4
  • Secondary loss of response (LOR): loss of response during maintenance treatment after initial response to induction therapy4

Why are infliximab trough levels and ADA measured for TDM in IBD?

Montioring of infliximab trough levels is associated with improved clinical outcomes during induction therapy and maintenance therapy.5,6 Detectable ADA is associated with decreased serum concentration of infliximab7-9 and understanding ADA status is important to inform clinical decision making in induction and maintenance therapy.7,10,11

Why use TDM?

Personalised medicine can be particularly effective in infliximab treatment as patients can require different strategies to optimise their therapy.5  A personalised approach using TDM can lead to improved clinical outcomes and more effective use of infliximab, which has potential cost-savings.12-15  

Limited therapeutic options are available for patients with IBD16 and maximising anti-TNF drug persistence may help to avoid hospitalisation and surgery.17

​​​​​​​Applying TDM in clinical practice

Even minimal information can inform treatment strategy . The simple algorithm below can be used to interpret TDM results in clinical practice.18,19

Table created from Khanna R, et a;. 2013 and Bedtzen K, et al. 2019.
+ IS, Immunosuppression
* Please note that Inflectra/infliximab is not licensed for dose escalation in ulcerative colitis, ankylosing spondylitis, psoriasis, psoriatic arthritis, paediatric ulcerative colitis or paediatric Crohn's disease.

Suggested infliximab threshold level for maintenance therapy ranges from >0.5 µg/ml to ≥10.1 µg/ml.20

Watch Dr Walter Reinisch discuss the benefits of using TDM in clinical practice:

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Optimising treatment with Inflectra

Learn more about TDM and biomarkers

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References
  1. Colombel J-F, et al. Inflamm Bowel Dis 2012. 18:349–358.
  2. Kingsley M, et al. Gastroenterol Hepatol 2016. 12:308–315.
  3. Tracey D, et al. Pharmacol Ther 2008. 117:244–279.
  4. Sprakes MB, et al. J Crohns Colitis 2012. 6:143–153.
  5. Adedokun O, et al. Gastroenterology 2014. 147:1296–1307.
  6. Bortlik M, et al. J Crohns Colitis 2013. 7:736–743.
  7. Ungar B, et al. Gut 2014. 63:1258–1264.
  8. Vermeire S, et al. Gut. 2007. 56:1226–1231.
  9. Van Stappen T, et al. Gut 2017. epub April 274.
  10. Roda G, et al. Clin Trans Gastroenterol 2016. 7:e135
  11. Golovics PA, et al. J Crohns Colitis 2017. 11:S4, ECCO abstract OP003.
  12. Vande Casteele N, et al. Gastroenterology 2015. 148:1320–1329.
  13. Steenholdt C, et al. Gut 2014. 63:919–927.
  14. Roblin X, et al. Journal of Market Access & Health Policy 2015. 3:292–29.
  15. Ding NS, et al. Aliment Pharmacol Ther 2016. 43:30-51.
  16. Velayos FS and Sandborn WJ. Curr Gastroenterol Hepatol 2007. 9:521–527.
  17. Pouillon L, et al. J Crohns Colitis 2017. 11:S4, ECCO abstract OP006.
  18. Khanna R, et al. Aliment Pharmacol Ther 2013. 38:447–459.
  19. Bendtzen K, et al. Scand J Gastroenterol 2009. 44:774–781.
  20. Mitrev N and Leong RW. Expert Opin Drug Saf 2017. 16:303–317.
PP-IFA-GBR-0442. March 2021

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