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"Any biological drug that is currently in use is potentially immunogenic"
Monoclonal antibody-based drugs used for the treatment of inflammatory disease can themselves be immunogenic1. If the patient’s immune response is triggered by the treatment the patient develops antibodies targeting and usually inactivating the drug itself. Once triggered this immune response can lead to unwanted reactions to subsequent drug infusion and reduces or eliminates the therapeutic benefit of treatment.
The most widely used biological TNFα inhibitors are infliximab, adalimumab and etanercept. Due to structural differences between these drugs their immunogenicity varies. Thus infliximab, which is derived from a mouse antibody, is relatively immunogenic, whereas adalimumab, which is modified to mimic a natural human antibody, tends to be less immunogenic.
The close correlation between the concentration of the circulating drug in blood, the immune response to the drug as determined by antibody titer and the patient’s ultimate response to treatment in terms of reduced clinical symptoms of disease is widely accepted.
1“Guidelines on the Clinical Investigation of the Pharmacokinetics of Therapeutic Proteins of 31 July 2007” EMA (http://www.emea.europa.eu/pdfs/human/ewp/8924904enfin.pdf)Advanced warning of reduced therapeutic efficacy
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Several studies of patients treated with infliximab and adalimumab for rheumatoid arthritis, spondyloarthritis, inflambatory bowel disease and psoriasis have shown that a decrease in the level of circulating drug is directly correlated with an immune response in the patient against the drug and thus that this unwanted immune response reduces the efficacy of treatment. Although treatment is generally beneficial in the first months after therapy begins, disease activity score begins to rise in parallel with a detectable immune response to the drug (appearance of anti-drug antibodies). Continued treatments with the drug may not produce a favorable disease evolution and in these cases either suspension of the treatment or switching to an alternative drug therapy is indicated. |
Promonitor® provides an informative insight into the patient response during treatment with biological therapies. Clinicians can tailor treatment to individual patients ensuring an optimized therapeutic regime and avoiding the unnecessary waste of time and expense associated with unguided dosing regimes. Of overriding importance is that this monitoring of response to therapy is of benefit to the patient by allowing a better quality of healthcare.
Automatic data analysis and result interpretation
Promonitor raw data analysis can be easily performed with MyAssays online application. Use the free MyAssays service to transform your measurement data to meaningful results in record time. There is no complicated software to install, learn or configure. Simply provide your raw data and parameters into the kit page on MyAssays and your results are calculated automatically. Your tailored report is available immediately through your web browser.
Access the complete list of analysis Pages here.
