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Monitoring biological drugs
Chronic inflammatory diseases are highly heterogeneous conditions characterized by over production of cytokines, essential components in a body's immune response, that when disregulated play a critical role in the pathogenesis of these diseases. Among the cytokines tumor necrosis factor alpha (TNFα) is a key trigger in the induction of the inflammatory cascade and therefore of disease symptoms.
The new generations of biological anti-TNFα drugs are recombinant antibody molecules that target TNFα thereby limiting the extent to which the inflammatory cascade is triggered.
Therapies based on this novel class of biological drugs have provided a much-needed alternative to clinicians for the treatment of chronic inflammatory diseases such as rheumatoid arthritis, inflammatory bowel disease (Crohn's disease and ulcerative colitis) and psoriasis among others. Despite the widespread success of these drugs however some patients do not respond satisfactorily or show a diminished response after prolonged drug treatment. The failure to respond to these treatments is primarily due to the immunogenicity of the drugs themselves, that is, the patient creates antibodies that target the drug itself thus neutralizing the beneficial effect of treatment and potentially even triggering an adverse drug response.
Objective selection of therapy and dosage
Administration of biologic drugs should always be performed in parallel with the close monitoring of the patient response to the drug in order to evaluate the efficacy of treatment and if necessary to adjust dosage or switch therapy.
Currently the assessment of patient response to the treatment of autoimmune and inflammatory diseases is based on patient reporting of symptom severity. While such measures are useful in assessing the impact of treatment on a patient’s quality of life this approach fails to provide an objective biological insight into the efficacy of treatment. The use of PROMONITOR® allows individualized optimization of treatment regimes, thereby increasing the clinical benefit to patients and avoiding the waste of time, money and opportunity spent on ineffective treatments. The goal of objectively measuring drug response is achieved by PROMONITOR® through the measurement of both drug bioavailability and immunogenicity.