TDM Checker: Deciding the correct therapy decisions

Monoclonal antibodies against inflammatory mediators, so called biologicals or biosimilars, have been used for the treatment of chronic inflammatory bowel diseases (IBD) such as Crohn’s disease and ulcerative colitis for more then 10 years.

For an optimal treatment, it is important to check the drug concentration in the patient’s blood (trough level), this can be done reactive or proactive. The therapy can be optimized based on the measured drug concentration.

R-Biopharm will stop with TDM checker and the treatment with Infliximab based on the Taxittrial results.

There are more biologicals/biosimilars then Infliximab, we have decided that the BridgeIBD Biologic-Therapy-Optimizer is better tool for you, the health care professional.

The following link will lead you to an interactive tool designed to assist healthcare professionals in interpreting the measured concentration of drug and anti-drug antibodies. Here you will find recommendations for infliximab (Remicade®), adalimumab (Humira®), vedolizumab (Entyvio®), golimumab (Simponi®) and ustekinumab (Stelara®). And the biosimilars for Infliximab (Remsima®, Inflectra ®, Flixabi®, Zessly®), Adalimumab (Amgevita®, Amsparity®, Hefiya®, Hulio®, Hyrimoz®, Idacio®, Imraldi®, Yufluma®).

The BRIDGe group is an association of gastroenterologists who are experts in the field of IBD patient care and focus on patient-centred clinical IBD research.

R-Biopharm AG has received permission from the BridgeIBD group to place the link to the BridgeIBD Biologic-Therapy-Optimizer.

Reference:

Appropriate Therapeutic Drug Monitoring of Biologic Agents for Patients With Inflammatory Bowel Diseases Konstantinos Papamichael, Adam S. Cheifetz, Gil Y. Melmed, Peter M. Irving, Niels Vande Casteele, Patricia L. Kozuch, Laura E. Raffals, Leonard Baidoo, Brian Bressler, Shane M. Devlin, Jennifer Jones, Gilaad G. Kaplan, Miles P. Sparrow, Fernando S. Velayos, Thomas Ullman and Corey A. Siegel

Interactive: TDM

BRIDGe’s interactive tool helps you make the right treatment decision based on measured drug concentrations.

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TDM

or Therapeutic Drug Monitoring means measuring the drug level in the patient’s blood in order to individually adjust the dose to the patient’s needs. This allows the drug to work optimally and reduces therapy costs.

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Choose the drug your patient is taking (currently only Infliximab available) and get started!

Which anti-TNF drug is your patient taking?

Please note: If the drug concentration of infliximab is >1 µg/mL, anti-drug antibody concentrations will be undetectable using the RIDASCREEN® Anti-IFX Antibodies. The RIDASCREEN® Anti-IFX Antibodies is a drug-sensitive test and cannot detect antibodies when infliximab concentrations are present. In addition, following Mitrev et al. there is insufficient evidence for the use of a drug-tolerant assay.

Infliximab

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Outcome

Potential action	Recommendation

Disclaimer

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.

Background

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:

Terms and conditions of use

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.