Biologics are genetically engineered drugs that target, with a high degree of specificity, components involved in the inflammatory process, such as cytokines, receptors, or immune cells.
Monitoring is important because drug levels can vary due to individual pharmacokinetics in
Even at the same dosage, the effects can vary greatly from patient to patient. In addition, antibodies (anti-drug antibodies, ADA) may develop during the course of treatment. These bind to the biologic, which can lead to a secondary loss of efficacy. Monitoring these substances is therefore essential for cost-effective treatment.
Monitoring of TNF-alpha Inhibitors
- Adalimumab (Humira®) is a human IgG1 monoclonal antibody 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. However, unlike adalimumab, it is a chimeric (human-murine) monoclonal IgG1κ antibody.
- Certolizumab pegol (Cimzia®) is a TNF-alpha inhibitor used to treat Crohn’s disease and rheumatoid arthritis. It is the Fab’ fragment of a recombinant, humanized antibody that is conjugated to polyethylene glycol (PEG) and is therefore also known as certolizumab pegol.
- Golimumab (Simponi®) is a human IgG1k monoclonal antibody used to treat rheumatic inflammatory diseases and chronic inflammatory bowel diseases.
We test serum or whole blood samples to determine TNF-alpha levels, the trough concentration of the active ingredient, and any anti-drug antibodies.
The following applies to all measurements: Blood should be drawn immediately before the medication is administered, or no more than 24 hours beforehand (trough level). If the test is performed after administration, it may yield a false-negative result for the detection of any antibodies against the drug.
Billing: For the determination of the three parameters (trough level, AK response to the medication, and TNF-alpha), we charge 261 CHF (2 × 1,194.00, 1 × 1,474.10, each at 87 CHF).
Monitoring of Integrin Antagonists
Vedolizumab ( Entyvio®), a humanized IgG1 monoclonal antibody, specifically binds to the α4β7 integrin (integrin antagonist). This biologic is used in patients with ulcerative colitis and Crohn’s disease for whom conventional therapy or TNF-α antagonists are not sufficiently effective or are not tolerated.
We test the trough concentration of the active ingredient and check for any anti-drug antibodies in serum or whole blood.
The following applies to all measurements: Blood should be drawn immediately before the medication is administered, or no more than 24 hours beforehand (trough level). If the test is performed after administration, it may yield a false-negative result for the detection of any antibodies against the drug.
Billing: To determine the two parameters (trough level and AK response to the medication), we charge 174 CHF (2 × 1,194.00 at 87 CHF each).
Monitoring of Complement Inhibitors
Bound eculizumab prevents its cleavage into the C5a and C5b fragments, thereby blocking the formation of the terminal complement complex C5b-9, known as the membrane attack complex. Eculizumab is already approved for the treatment of paroxysmal nocturnal hemoglobinuria and atypical hemolytic uremic syndrome. More indications are sure to follow.
In vitro, treatment can be monitored by measuring complement activity, since eculizumab leads to a complete blockade of complement activity. As part of our monitoring services, you can have us measure your serum complement activity. In this process, all three paths are determined together.
Billing: However, only the alternative and the traditional routes are billed (TP 1493 at 45 CHF each, TP 1494 at 36 CHF each). To ensure the accuracy of the analysis, the material must be frozen and arrive at our facility on dry ice at -70°C.