• Innovative CLIA technology
  • Quantitative measurement of drug and anti-drug antibodies
  • First results in less than 35 minutes; 60 results/hour
  • Standardised to the Adalimumab 1st International Standard (NIBSC 17/236)
  • Validated on Adalimumab drug (Humira®) and biosimilars: ABP 501 (Amgevita®) and SB5 (Imraldi®)

i-Tracker Adalimumab is an automated assay intended for the quantitative measurement of Adalimumab (anti-TNFα agent) in human serum or plasma samples.

Anti-TNFα are therapeutic agents widely used to treat patients with various inflammatory diseases. Adalimumab is one of the anti-TNFα agents recommended for the treatment of the rheumatoid arthritis, Crohn’s disease, ankylosing spondylitis, etc.  This human monoclonal antibody can bind TNFα, blocking the action of the TNFα responsible for the inflammatory state.

However, during the treatment, some patients can develop antibodies against Adalimumab.  Consequently, the plasma level of anti-TNFα decreases and simultaneously the disease symptoms reappear or increase.

Studies have shown that the trough level of a TNFα therapy (i.e. the circulating drug level just before the next injection) usually correlates with clinical efficacy.  This trough level is influenced by several factors, among them dosage and frequency of the injections, disease phenotype and activity, pharmacogenetic factors, co-medication and the formation of anti-drug antibodies.

Quantitative measurements of anti-TNFα drug level in combination with anti-drug antibodies provides to the treating physician help for therapeutic guidance, allowing maximum treatment efficacy whilst minimising cost impact.

i-Tracker Adalimumab assay is validated to monitor drug levels of any biological drug which contains the active substance Adalimumab, that is the original drug Humira®, and any biosimilar drug like ABP501 (Amgevita®) and SB5 (Imraldi®).  It is standardised against the NIBSC/WHO Adalimumab 1st International Standard (code: 17/236).

  • Bressler B & al. Clinical Practice Guidelines for the Medical Management of Non-hospitalized Ulcerative Colitis: The Toronto Consensus. Gastroenterology 2015;148:1035 – 1058.
  • Lichtenstein, G et al. Clinical Guideline: Management of Crohn’s Disease in Adults. Am J Gastroenterol 2018; 113:481–517.
  • Diagnostics Guidance [DG22] on Therapeutic monitoring of TNF-alpha Inhibitors in Crohn’s Disease. https://www.nice.org.uk/guidance/dg22/chapter/1-Recommendations
  • Maaser C et al. ECCO-ESGAR Guideline for Diagnostic Assessment in IBD Part 1: Initial diagnosis, monitoring of known IBD, detection of complications. J Crohns Colitis. 2019 Feb 1;13(2):144-164.
  • Feuerstein J D. et al. Therapeutic Drug Monitoring in Inflammatory Bowel Disease. Gastroenterology. 2017:1-8.
  • Gomollón F at al. 3rd European Evidence-based Consensus on the Diagnosis and Management of Crohn’s Disease. J Crohns Colitis. 2016:1-23.
  • Khan A et al. New Zealand Society of Gastroenterology Guidelines on Therapeutic Drug Monitoring in Inflammatory Bowel Disease. N Z Med J. 2019 Mar 8;132(1491):46-62.
  • Lamb CA et al. British Society of Gastroenterology consensus guidelines on the management of inflammatory bowel disease in adults. Gut 2019;0:1–106.
  • Turner D et al. Management of Paediatric Ulcerative Colitis, Part 1: Ambulatory Care-An Evidence-based Guideline From European Crohn’s and Colitis Organization and European Society of Paediatric Gastroenterology, Hepatology and Nutrition. J Pediatr Gastroenterol Nutr. 2018 Aug;67(2):257-291.
  • Harbord M et al. Third European Evidence-based Consensus on Diagnosis and Management of Ulcerative Colitis. Part 2: Current Management. Journal of Crohn’s and Colitis, 2017, 1–24.
  • Mitrev N et al. Consensus statements on therapeutic drug monitoring of anti-tumour necrosis factor therapy in inflammatory bowel diseases. Aliment Pharmacol Ther. 2017 Dec;46(11-12):1037-1053.
  • Peyrin-Biroulet L et al. French National Consensus Clinical Guidelines for the Management of Crohn’s disease. Dig Liver Dis. 2016.
  • Peyrin-Biroulet L et al. French National Consensus Clinical Guidelines for the Management of Ulcerative Colitis. Dig Liver Dis. 2016; 48(7):726-33.
  • Ruemmele F.M. et al. Consensus guidelines of ECCO/ESPGHAN on the medical management of pediatric Crohn’s disease. Journal of Crohn’s and Colitis (2014).
  • Kopylov U et al. Therapeutic Drug Monitoring in Inflammatory Bowel Disease. Gastroenterology. 2017;153(3):835-857.
  • Gomollón F et al. 3rd European Evidence-based Consensus on the Diagnosis and Management of Crohn’s Disease. J Crohns Colitis. 2017; 11(1):3-25.
  • Wadhwa M et al. World Health Organization, WHO Expert Committee on Biological Standardization. (2019). Report on a collaborative study for proposed 1st international standard for Adalimumab. WHO/BS/2019.2365.

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Immuno-Trol i-Tracker Adalimumab

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