Clinical information
In severe cases of rheumatic diseases, chronic inflammatory bowel diseases, multiple sclerosis and psoriasis, biotechnologically produced monoclonal antibodies are often used as therapeutic agents when patients do not respond adequately to conventional therapeutics or these are contraindicated. The biologics act as selective inhibitors of pathogenetically relevant target structures.
Biologics have the potential to influence the natural course of these progressive diseases. Treatment with increasing doses may help to alleviate the clinical symptoms. However, once the optimal concentration range has been reached, increasing the dose further will not significantly improve symptoms and may lead to secondary loss of response or unwanted side effects. To ensure appropriate levels in the body, the drug dose must be adjusted taking into account how the biologic is metabolised in the patient. Monitoring of the patient’s response to these biologics is key to managing treatments thus ensuring maximum efficacy and reduce risk for loss of response.
Therapeutic drug monitoring (TDM) is the monitoring of drug levels and presence of anti-drug antibodies (ADA) in the blood for the determination of an individual’s optimal dose. This helps to avoid underdosing with insufficient effect and overdosing with severe side effects and ensures that the level of the biologic in the individual is within the defined therapeutic range prior to subsequent biotherapy administrations. For these reasons, TDM is seen as a pillar of personalised medicine to improve the management of chronic inflammatory diseases.
Therapy monitoring
Continuous therapy monitoring of drug and ADA levels allows individual adjustment of the drug dose or administration interval, ensuring individualised, targeted and cost-efficient patient management.
Proactive TDM is the regular monitoring of drug and ADA levels in patients during the induction phase to understand how the biologic is being metabolised in the patient’s body in order to optimise the dose and timing of biotherapy administration. This testing should continue 2 to 3 times per year during the maintenance phase. This allows dose adjustments to the biologic to ensure treatment efficacy and clinical remission, thereby preventing recurrence of symptoms.
Reactive TDM is the monitoring of drug levels in patients in the maintenance phase and is used following a loss of response in order to adjust the treatment and restore clinical response.
Both TDM strategies have been shown to be effective in supporting patient management and reducing treatment costs.
A drastic decrease in the drug level is an indication that the patient is producing ADA. These endogenous antibodies complex the drug, leading to early elimination from the body and/or inhibition of the mechanism of action. In particular, high levels of ADA can lead to a loss of the drug’s medical effect and the need for a change of drug or agent.
Additional controls (IMMUNO-TROLs) are available for all products.
Manufacturer: Biosynex Theradiag SA products are only available in selected countries: Please contact your local Euroimmun sales representative.
| Technology | Parameter | Substrate | Species | Calibration | Ig Class | Format | Order No. |
|---|---|---|---|---|---|---|---|
| ELISA | LISA-TRACKER Adalimumab | Anti-Adalimumab-coated microplate wells |
48 x 01 |
LTA 002-481 | |||
| ELISA | LISA-TRACKER anti-Adalimumab | Adalimumab-coated microplate wells |
48 x 01 |
LTA 003-481 | |||
| ELISA | LISA-TRACKER Duo Adalimumab | Anti-Adalimumab- and Adalimumab-coated microplate wells |
48 x 02 |
LTA 0051 | |||
| ELISA | LISA-TRACKER Bevacizumab | Anti-Bevacizumab-coated microplate wells |
48 x 01 |
LTB 002-481 | |||
| ELISA | LISA-TRACKER anti-Bevacizumab | Bevacizumab-coated microplate wells |
48 x 01 |
LTB 003-481 | |||
| ELISA | LISA-TRACKER Certolizumab | Anti-Certolizumab-coated microplate wells |
48 x 01 |
LTC 002-481 | |||
| ELISA | LISA-TRACKER anti-Certolizumab | Certolizumab-coated microplate wells |
48 x 01 |
LTC 003-481 | |||
| ELISA | LISA-TRACKER Duo Certolizumab | Anti-Certolizumab- and Certolizumab-coated microplate wells |
48 x 02 |
LTC 0051 | |||
| ELISA | LISA-TRACKER Etanercept | Anti-Etanercept-coated microplate wells |
48 x 01 |
LTE 002-481 | |||
| ELISA | LISA-TRACKER anti-Etanercept | Etanercept-coated microplate wells |
48 x 01 |
LTE 003-481 | |||
| ELISA | LISA-TRACKER Golimumab | Anti-Golimumab-coated microplate wells |
48 x 01 |
LTG 002-481 | |||
| ELISA | LISA-TRACKER anti-Golimumab | Golimumab-coated microplate wells |
48 x 01 |
LTG 003-481 | |||
| ELISA | LISA-TRACKER Duo Golimumab | Anti-Golimumab- and Golimumab-coated microplate wells |
48 x 02 |
LTG 0051 | |||
| ELISA | LISA-TRACKER Infliximab | Anti-Infliximab-coated microplate wells |
48 x 01 |
LTI 002-481 | |||
| ELISA | LISA-TRACKER anti-Infliximab | Infliximab-coated microplate wells |
48 x 01 |
LTI 003-481 | |||
| ELISA | LISA-TRACKER Duo Infliximab | Anti-Infliximab- and Infliximab-coated microplate wells |
48 x 02 |
LTI 0051 | |||
| ELISA | LISA-TRACKER Rituximab | Anti-Rituximab-coated microplate wells |
48 x 01 |
LTR 002-481 | |||
| ELISA | LISA-TRACKER anti-Rituximab | Rituximab-coated microplate wells |
48 x 01 |
LTR 003-481 | |||
| ELISA | LISA-TRACKER Duo Rituximab | Anti-Rituximab- and Rituximab-coated microplate wells |
48 x 02 |
LTR 005 1 | |||
| ELISA | LISA-TRACKER Secukinumab | Anti-Secukinumab-coated microplate wells |
48 x 01 |
LTS 002-481 | |||
| ELISA | LISA-TRACKER anti-Secukinumab | Secukinumab-coated microplate wells |
48 x 01 |
LTS 003-481 | |||
| ELISA | LISA-TRACKER Tocilizumab | Anti-Tocilizumab-coated microplate wells |
48 x 01 |
LTT 002-481 | |||
| ELISA | LISA-TRACKER anti-Tocilizumab | Tocilizumab-coated microplate wells |
48 x 01 |
LTT 003-481 | |||
| ELISA | LISA-TRACKER TNF | Anti-TNFα-coated microplate wells |
96 x 01 |
LTT 004-96 1 | |||
| ELISA | LISA-TRACKER Duo Tocilizumab | Anti-Tocilizumab- and Tocilizumab-coated microplate wells |
48 x 02 |
LTT 0051 | |||
| ELISA | LISA-TRACKER Trastuzumab | Anti-Trastuzumab-coated microplate wells |
48 x 01 |
LTTR 002-481 | |||
| ELISA | LISA-TRACKER anti-Trastuzumab | Trastuzumab-coated microplate wells |
48 x 01 |
LTTR 003-481 | |||
| ELISA | LISA-TRACKER Ustekinumab | Anti-Ustekinumab-coated microplate wells |
48 x 01 |
LTU 002-481 | |||
| ELISA | LISA-TRACKER anti-Ustekinumab | Ustekinumab-coated microplate wells |
48 x 01 |
LTU 003-481 | |||
| ELISA | LISA-TRACKER Duo Ustekinumab | Anti-Ustekinumab- and Ustekinumab-coated microplate wells |
48 x 02 |
LTU 0051 | |||
| ELISA | LISA-TRACKER Vedolizumab | Anti-Vedolizumab-coated microplate wells |
48 x 01 |
LTV 002-481 | |||
| ELISA | LISA-TRACKER anti-Vedolizumab | Vedolizumab-coated microplate wells |
48 x 01 |
LTV 003-481 | |||
| ELISA | LISA-TRACKER Duo Vedolizumab | Anti-Vedolizumab- and Vedolizumab-coated microplate wells |
48 x 02 |
LTV 0051 | |||
| ChLIA | i-Tracker Adalimumab | Anti-Adalimumab-coated magnetic particles | quantitative |
100 x 01 |
CTA 002-1001 | ||
| ChLIA | i-Tracker Anti-Adalimumab | Adalimumab-coated magnetic particles | recombinant Adalimumab |
quantitative |
100 x 01 |
CTA 003-1001 | |
| ChLIA | i-Tracker Anti-Adalimumab Total Ab | Adalimumab-coated magnetic particles |
50 x 01 |
CTA 003T-501 | |||
| ChLIA | i-Tracker Certolizumab |
Anti-Certolizumab-coated magnetic particles |
quantitative |
50 x 01 |
CTC 002-501 | ||
| ChLIA | i-Tracker Anti-Certolizumab | Certolizumab-coated magnetic particles | recombinant Certolizumab |
quantitative |
50 x 01 |
CTC 003-501 | |
| ChLIA | i-Tracker Etanercept | Anti-Etanercept-coated magnetic particles |
50 x 01 |
CTE 002-501 | |||
| ChLIA | i-Tracker Anti-Etanercept | Etanercept-coated magnetic particles |
50 x 01 |
CTE 003-501 | |||
| ChLIA | i-Tracker Golimumab | Anti-Golimumab-coated magnetic particles |
quantitative |
50 x 01 |
CTG 002-501 | ||
| ChLIA | i-Tracker Anti-Golimumab | Golimumab-coated magnetic particles | recombinant Golimumab |
quantitative |
50 x 01 |
CTG 003-501 | |
| ChLIA | i-Tracker Infliximab | Anti-Infliximab-coated magnetic particles |
quantitative |
100 x 01 |
CTI 002-1001 | ||
| ChLIA | i-Tracker Anti-Infliximab | Infliximab-coated magnetic particles | recombinant Infliximab |
quantitative |
10 x 001 |
CTI 003-1001 | |
| ChLIA | i-Tracker Anti-Infliximab Total Ab | Infliximab-coated magnetic particles |
50 x 01 |
CTI 003T-501 | |||
| ChLIA | i-Tracker Ocrelizumab | Anti-Ocrelizumab-coated magnetic particles |
50 x 01 |
CTO 002-501 | |||
| ChLIA | i-Tracker Anti-Ocrelizumab | Ocrelizumab-coated magnet particles |
50 x 01 |
CTO 003-501 | |||
| ChLIA | i-Tracker Rituximab | Anti-Rituximab-coated magnetic particles |
quantitative |
50 x 01 |
CTR 002-501 | ||
| ChLIA | i-Tracker Anti-Rituximab | Rituximab-coated magnetic particles | recombinant Rituximab |
quantitative |
50 x 01 |
CTR 003-501 | |
| ChLIA | i-Tracker Risankizumab | Anti-Risankizumab coated magnetic particles |
50 x 01 |
CTRZ 002-501 | |||
| ChLIA | i-Tracker Anti-Risankizumab | Risankizumab coated magnetic particles |
50 x 01 |
CTRZ 003-501 | |||
| ChLIA | i-Tracker Ustekinumab | Anti-Ustekinumab-coated magnetic particles |
quantitative |
50 x 01 |
CTU 002-501 | ||
| ChLIA | i-Tracker Anti-Ustekinumab | Ustekinumab-coated magnetic particles | recombinant Ustekinumab |
quantitative |
50 x 01 |
CTU 003-501 | |
| ChLIA | i-Tracker Vedolizumab | Anti-Vedolizumab-coated magnetic particles |
quantitative |
50 x 01 |
CTV 002-501 | ||
| ChLIA | i-Tracker Anti-Vedolizumab | Vedolizumab-coated magnetic particles | recombinant Vedolizumab |
quantitative |
50 x 01 |
CTV 003-501 | |
|
* For research use only, not for in vitro diagnostic use in the sense of EU directive 98/79/EC. 1 Product manufactured by third party. Please contact your local Euroimmun representative for more information. | |||||||