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Therapeutic Drug Monitoring

Overview

The use of Biological drugs to inhibit inflammatory integrins (e.g. α4β7) and cytokines (e.g. TNFα) in Inflammatory Bowel Disease (IBD) requires a personalised approach. The long term effectiveness of biological drugs used to treat chronic inflammation is strongly influenced by bioavailability, pharmacokinetics and immunogenicity of the drug used.

Serum trough levels help to ensure an adequate drug concentration is maintained within a 'therapeutic window'. Furthermore, anti-TNFα Blockers (e.g. Infliximab, Adalimumab, and biosimilars) and anti-α4β7 integrin blockers (e.g. Vedolizumab) may trigger immunogenic responses in individuals which can reduce the serum concentration of the drugs and alter their effectiveness.

Anti-Drug-Antibodies (ADA), impede drug activity and may cause severe allergic reactions. A concomitant therapy with immunosuppressants can reduce antibody formation but is not always indicated.

Drug Level Assays

Being able to stratify patients according to whether they are likely to benefit from the treatment has both clinical and economic advantages because not all patients respond equally to biological therapies such as anti-TNFα blockers. 

Some patients will respond well with fewer symptoms with a reduction in inflammatory biomarkers (e.g. faecal calprotectin) and endoscopic scores, while others will fail to respond during the induction phase of treatment, or lose response over time.

Measuring serum drug levels of biological drugs such as Infliximab, Adalimumab, Golimumab and Vedolizumab helps identify those patients with measurable drug trough levels who are more likely to reach clinical remission.

IDKmonitor® assays from BIOHIT HealthCare are highly specific for the target drug and are used widely for routine clinical and research applications.

  • Assess and manage loss of response and primary non-response
  • Assess patient compliance with self-administered (sub-cutaneous) biologics (e.g. adalimumab, golimumab)
  • Predict efficacy of re-initiating therapy after drug holiday
  • Test before switching to Biosimilars
  • Predict response to anti-TNFα withdrawal

Anti-drug Antibody Assays

Anti-TNFα drugs are recombinant proteins that can induce humoral immune responses and lead to anti-drug antibody formation; a major cause of loss of response.

The formation of anti-drug antibodies depends on the treatment strategy employed and combination therapy with immunomodulators has been shown to help reduce the immunogenicity of biological drugs. For example in Crohn’s disease the use of immunomodulators along side Infliximab reduces the number of patients that will develop anti-drug antibodies.

Assays that detect anti-drug antibodies can help optimise therapy, direct switching to other biologics, and indicate the need for immunomodulators.

IDKmonitor® assays for anti-drug antibodies are used widely in routine clinical and research settings.

  • TOTAL and Free Anti-drug Antibody assays
  • Highly specific for target antibodies
  • Assess and manage loss of response
  • Predict dose escalation outcome
  • Direct immunomodulator use
  • Predict success of re-initiating therapy after drug holiday
  • Direct switching to other biologics

Instructions

Assays for monitoring drug levels

Product Code Description Instructions
 K9655 Infliximab Drug Level ELISA. 96 wells.  Download
 K9657 Adalimumab Drug Level ELISA. 96 wells.  Download
 K9656 Golimumab Drug Level ELISA. 96 wells.  Download
 K9646 Etanercept Drug Level ELISA. 96 wells.  Download
 K9658 Vedolizumab Drug Level ELISA. 96 wells.  Download
 K9660 Ustekinumab Drug Level ELISA. 96 wells.  Download
  Related Product:  
 K9610 Serum TNFα ELISA. 96 wells.  Download

 

Assays for the determination of FREE Anti-Drug-Antibodies

Product Code Description Instructions
 K9650 Infliximab FREE Anti-drug Antibody (ADA) ELISA. 96 wells.  Download
 K9652 Adalimumab FREE Anti-drug Antibody (ADA) ELISA. 96 wells.  Download
 K9649 Golimumab FREE Anti-drug Antibody ELISA. 96 wells.  Download
 K9653 Etanercept FREE Anti-drug Antibody ELISA. 96 wells.  Download

 

Assays for the determination of TOTAL Anti-Drug-Antibodies

Product Code Description Instructions
 K9654 Infliximab TOTAL Anti-drug Antibody ELISA. 96 wells.  Download
 K9651 Adalimumab TOTAL Anti-drug Antibody ELISA. 96 wells.  Download

 

If you need advice on which assays to select please don't hesitate to contact us on +44 151 550 4 550 or info@biohithealthcare.co.uk

Clinical background

Measuring TNFα levels and Anti-drug Antibodies

Long term care plans for patients with chronic inflammatory diseases aim to induce and maintain clinical remission.  However in some patients an adequate reponse is not achieved when treatment with TNFα inhibitors is initiated (Primary non-responders) and a large proportion of patients lose response over time (secondary loss of response).  In these patients, relapse is more common.

It has been demonstrated that detectable infliximab trough levels have a positive association with clinical remission in Ulcerative Colitis, whilst patients with negative levels are more likely to require colectomy (Seow et al. Gut 2009).  The formation of anti-drug-antibodies plays a big role in loss of response too and can depend on the individual being treated and the therapeutic strategy chosen (Maser et al. Clin Gastroenterol Hepatol 2006). Anti-drug antibodies produced by the patient bind and neutralise the TNFα inhibitors and render them ineffective.  Monitoring the efficacy of TNFα inhibitors may help clinicians schedule a successful individualised treatment strategy for their patients.

TOTAL- and Free-Anti-drug Antibody ELISAs

Two types of anti-drug antibody assays are available: TOTAL anti-drug antibody ELISAs and Free anti-drug antibody ELISAs. TOTAL anti-drug antibody ELISAs enable the detection of anti-drug antibodies in the presence of circulating drug, and so with these so-called "Drug Tolerant" assays lower titres can be detected with a higher sensitivity.

A recent study examining the effectiveness of TOTAL Anti-infliximab Antibody assays vs. FREE Anti-infliximab antibody assays in 29 patients with Crohn's Disese on maintenance therapy using Infliximab demonstrated that Anti-drug antibodies s were detected in 24.1% and 3.4% patients respectively (Semmler et al 2014).

TOTAL anti-drug antibody analysis may be advantageous when using combination therapy such as immunosuppressants due to the increased sensitivity of the assays.

Ordering


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Orders to sales@biohithealthcare.co.uk or fax to +44 (0)151 550 4 550

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