TDM Checker

The TDM Checker is a tool intended to provide assistance for health care professionals such as gastroenterologists, laboratory personnel and specialized nurses regarding the interpretation of drug and anti-drug antibody concentrations, as measured using the RIDASCREEN® and RIDA®QUICK tests. It is known, that different infliximab and anti-infliximab antibody monitoring assays may report different concentrations due to assay-specific variabilities in performance. It is advisable to use one single assay to measure drug and anti-drug antibodies in patients.

The threshold concentrations of the TDM Checker have been based on trough concentrations during maintenance phase, i.e. the drug and anti-drug antibody concentration just before the next dose administration. Different threshold concentrations may apply for samples withdrawn at peak or intermediate time points.

PLEASE NOTE: The TDM Checker is a supporting tool only and has to be used strictly in conjunction with other clinical, biological and endoscopic findings.

IT DOES NOT REPLACE PROPER CLINICAL JUDGEMENT.

It is recommended to test for drug and anti-drug antibody trough concentrations at consecutive doses to optimize treatment (Dreesen et al. Clinical Pharmacology: Advances and Applications 2017;9:10-111). Please adhere to local guidelines for the management of patients treated with biological drugs.

Various patient, drug and disease specific characteristics are known to influence treatment outcomes in patients with inflammatory bowel diseases, such as baseline disease activity, treatment adherence and immunogenicity. In addition, higher trough concentrations have been suggested to be associated with response and remission in patients with specific disease phenotypes, such as patients with perianal disease, or when targeting endoscopic healing. The drug and anti-drug antibody concentration should therefore – in any case – not be interpreted as the sole indicator of a treatment change and have to be used in the context of the clinical status of the patient and together with other laboratory results.

The TDM Checker has been developed based on consensus statements, appropriateness scores and evidence from pivotal clinical studies. The described situations reflect real-life clinical practice, but may not be entirely representative for each and every individual patient. It is based on the following studies:

• Vande Casteele et al. Gastroenterol 2015. doi: 10.1053/j.gastro.2015.02.031
• Melmed et al. Clin Gastroenterol Hepatol 2016. doi: 10.1016/j.cgh.2016.05.010
• Mitrev et al. Aliment Pharmacol Ther 2017. doi: 10.1111/apt.14368
• Imbrechts et al. J Pharm Biomed Anal 2019. doi: 10.1016/j.jpba.2019.112842

The TDM Checker is a supporting tool only and has to be used strictly in conjunction with other clinical, biological and endoscopic findings.

IT DOES NOT REPLACE PROPER CLINICAL JUDGEMENT.

Although carefully drafted to the best of its knowledge, the site owner and/or its affiliates do not assume any liability regarding the content of the TDM Checker tool and/or any respective results nor provide any warranties whatsoever. The user accepts that the usage of the TDM Checker tool is at his or her complete responsibility and therefore will indemnify and hold harmless the site owner and/or its affiliates from any claims resulting out of or in connection with the usage of the TDM Checker tool. By clicking the “accept terms and conditions of use” button below, the user claims to have read and to have accepted these terms and conditions of use.