Biotherapy Monitoring

Therapeutic Drug Monitoring (TDM) of Biologics with Theradiag

Theradiag TRACKER – leaders in Therapeutic Drug Monitoring

Theradiag is the market leader in Therapeutic Drug Monitoring (TDM) with assays validated and supported by the pharmaceutical industry.
Why use Theradiag TRACKER for Therapeutic Drug Monitoring
 • Pioneer and expert in TDM of biotherapies
 • Unique TDM menu with 12 different kits available for drug and anti-drug antibodies
 • Full coverage of biotherapies used in IBD, but also other chronic inflammatory diseases and oncology
 • Accurate quantitative measurement of drug and anti-drug antibodies
 • Easy-to-use with standardized protocols from sample collection to result interpretation
 • Clinically validated with measurement ranges tailored to induction and maintenance treatment phases
 • Flexible kit formats:
    - Easy-to-implement ELISA kits validated on automated platforms (DS2, DSX, etc.)
    - Fully automated CLIA kits on random-access i-Track10 analyser
 • Validated on biosimilars
 • Validated and supported by the pharmaceutical industry
 • Validated in accordance with the WHO international standards
 • TRACKER kits included in a large number of studies and publications

Theradiag and the Scientific approach to TRACKER for use in TDM
 • Therapeutic Drug monitoring helps physicians to make rational therapeutic decisions during the course of the disease and to support the proper use of drugs
 • Proactive and reactive TDM during treatment induction and maintenance to maximise the clinical benefits of biotherapies while minimising side effects
 • TDM approach leads to major cost savings in healthcare settings compared to a clinically based approach
 • Update on the latest data available for therapeutic windows for all molecules used in IBD

TDM in Chronic Inflammatory Diseases (CID)

Biologic therapies, and notably Monoclonal antibodies (mAbs) and Fusion Proteins (FP), have revolutionised the management of CID, such as Inflammatory Bowel Disease, Rheumatoid Arthritis, Ankylosing Spondylitis, Psoriasis and Psoriatic Arthritis that affect millions of people worldwide.

These drugs have the potential to alter the natural history of these progressive diseases. Unfortunately, Primary Non-Response (PNR) and Secondary loss of Response (SLR) to biologics occur in a significant proportion of patients. Remission is achieved in only approximately 40% of patients treated by biologics and in those who reached remission, the annual rate of Loss of Response (LOR) is more than 10%.

TDM, whereby measurements of biologic drug levels and antibodies against the biologic, is now seen as one of the cornerstones of personalised medicine used to improve the treatment of CID.

Reactive TDM concerns patients with manifest treatment failure, either PNR or SLR. It provides information about the cause of treatment failure and offers a rationale for subsequent therapeutic decisions to recapture response. Superiority of Reactive TDM over standard treatment is well documented and now is being recommended in Guidelines for patient management.

Similarly, Proactive TDM is a complementary approach provided to patients in remission and aims to adjust biologic treatment intensity according to individual pharmacokinetic and pharmacodynamic conditions. It helps to minimize the risk of later treatment failure linked to underexposure to the biologic, and to reduce treatment intensity to save costs in case of overexposure. Proactive TDM is emerging as new standard of care.

The use of TDM either reactively or proactively has also proven to be a cost-effective strategy to reduce the high burden cost of CID.

Theradiag, as a pioneer and leader in the monitoring of Biologics offers a full range of products to monitor patients with CID and treated by biologics or biosimilars:

    Adalimumab (anti-TNFα)
    Etanercept (anti-TNFα)
    Certolizumab-pegol (anti-TNFα)
    Golimumab (anti-TNFα)
    Infliximab (anti-TNFα)
    Rituximab (anti-CD20)
    Secukinumab (anti-IL17A)
    Tocilizumab (anti-IL6R)
    Ustekinumab (anti-IL12-IL23)
    Vedolizumab (anti-integrin α4β7)

TDM in Onclogy
The current dosing approach in oncology especially for targeted therapies such as mAbs is known to be suboptimal for some patients. The dosing strategies need to be improved to reach an optimal drug exposure in each individual patient.

Individualisation of biologic dosing guided by TDM therefore is seen to have the same potential value in oncology, similar as it has shown to be in CID.

Theradiag continues to innovate by offering now theranostics tools to allow the monitoring of biologics used in oncology:

    Rituximab (anti-CD20)
    Bevacizumab (anti-VEGF)
    Trastuzumab (anti-HER2)

When to perform TDM?

 Results Interpretation

• Drug levels required to improve clinical outcomes may vary between patients and depend on the desired therapeutic endpoint
• In patients with undectable drug levels, anti-drug antibody (ADAb) quantification helps to identify how to improve patient response
• In patients with high anti-drig antibody levels, a switch in class may be necessary
• In patients with low anti-drug antibody levels, the addition of an immunosuppressive drug may improve clinical outcomes

Example of therapeutic decision alogrithm in patient with loss of response


Biological drug concentration thresholds associated with favourable therapeutic outcomes in Inflammatory Bowel Diseases

Biologic Drug Treatment

Suggested drug concentration thresholds for clinical response/remission (μg/ml)

Suggested drug concentration thresholds for mucosal healing (μg/ml)
Infliximab Induction (wk 2) ≥20 ≥25
Induction (wk 6) ≥10 n/a
Postinduction (wk 14) ≥3 ≥7
Maintenance ≥3 ≥7
Adalimumab Postinduction (wk 14) ≥5 ≥7
Maintenance ≥3 ≥8
Certolizumab pegol  Postinduction (wk 6) ≥32 n/a
Maintenance ≥15 n/a
Golimumab Postinduction (wk 6) ≥2.5 n/a
Maintenance ≥1 n/a
Vedolizumab Induction (wk 2) ≥28 n/a
Induction (wk 6) ≥24 n/a
Postinduction (wk 14) ≥15 ≥17
Maintenance ≥12 ≥14
Ustekinumab Postinduction (wk 8) ≥3.5 n/a
  Maintenance ≥1 ≥4.5
Therapeutic drug monitoring in inflammatory bowel disease: for every patient and every drug? Papamichael K et al. Curr Opin Gastroneterol. 2019 Apr 9