Biologics are genetically engineered drugs that target highly specific components involved in the inflammatory process, e.g. cytokines, receptors or immune cells.
Monitoring is important, as the drug levels can change due to the individual pharmacokinetics of the patient.
The same dosage can vary greatly from patient to patient. In addition, antibodies (anti-drug antibodies, ADA) may form during the course of treatment. These bind the biologic, which can lead to a secondary loss of efficacy. Monitoring these substances is therefore essential for cost-effective therapy.
Monitoring of TNF-alpha inhibitors
- Adalimumab (Humira®) is a human monoclonal IgG1 antibody and is used to treat patients with chronic inflammatory bowel disease, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis and psoriasis.
- Infliximab (Remicade®) is also used to treat patients with chronic inflammatory bowel disease, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis and psoriasis. Unlike adalimumab, however, it is a chimeric (human-murine) monoclonal IgG1κ antibody.
- Certolizumab pegol (Cimzia®) is a TNF-alpha inhibitor that is used to treat Crohn’s disease and rheumatoid arthritis. It is the Fab’ fragment of a recombinant, humanized antibody that is conjugated with polyethylene glycol (PEG) and is therefore also known as Certolizumab pegol.
- Golimumab (Simponi®) is a human monoclonal IgG1k antibody that is used to treat rheumatic inflammatory and chronic inflammatory bowel diseases.
We check the TNF-alpha level, the trough level concentration of the active substance and any anti-drug antibodies from serum or native blood.
The following applies to all determinations: The blood sample should be taken immediately before the drug is administered, at most 24 hours before (trough level). If it is carried out after administration, the test for the detection of any antibodies against the drug may be falsely negative.
Billing: We charge CHF 261 (2x 1194.00, 1x 1474.10 at CHF 87 each) for the determination of the three parameters (trough level, AK against the drug and TNF-alpha).
Monitoring of integrin antagonists
Vedolizumab (Entyvio®), a humanized monoclonal IgG1 antibody, binds specifically to α4β7 integrin (integrin antagonist). This biologic is used in patients with ulcerative colitis and Crohn’s disease in whom conventional therapy or TNF-α antagonists are not sufficiently effective or are not tolerated.
We check the trough level concentration of the active substance and any anti-drug antibodies from serum or native blood.
The following applies to all determinations: The blood sample should be taken immediately before the drug is administered, at most 24 hours before (trough level). If it is carried out after administration, the test for the detection of any antibodies against the drug may be falsely negative.
Billing: We charge CHF 174 (2x 1194.00 à CHF 87) for the determination of the two parameters (trough level and AK against the drug).
Monitoring of complement inhibitors
The bound eculizumab prevents its cleavage into the fragments C5a and C5b and thus blocks the formation of the terminal complement complex C5b-9, the so-called membrane attack complex. Eculizumab is already approved for paroxysmal nocturnal hemoglobinuria and atypical hemolytic uremic syndrome. Further indications are sure to follow.
In vitro, the therapy can be monitored by measuring complement activity, as eculizumab leads to a complete blockade of complement activity. As part of the monitoring process, you can have your complement activity measured in serum. All three paths are determined together.
Billing: However, only the alternative and the classic route are billed (TP 1493 at CHF 45, TP 1494 at CHF 36). To ensure the accuracy of the analysis, the material must arrive frozen on dry ice at -70°C.