October 29, 2002
Interleukin Genetics (NASDAQ: ILGN) and the School of Health and Related Research (ScHARR, U.K.) have developed pharmacogenetic tests for response to rheumatoid arthritis (RA) drugs. A group from ScHARR presented findings at the 66th Annual Scientific Meeting of the American College of Rheumatology.
The importance of the cytokines IL-1 and TNFa in RA disease activity differs between individuals, leading to the hypothesis that gene variations in IL-1 or TNFa could predict clinical response to anti-IL-1 or anti-TNFa drug therapies. For example, previous study showed that alleles of the IL-1A gene correlated with response to Amgen’s (NASDAQ: AMGN) Kineret (anakinra). Carriers of the “+4845” allele responded 63% of the time compared to a 26% response rate for non-carriers. Another study may lead to predictions of response to Amgen’s Enbrel.
Investigators Bansback and Brennan developed a decision analytic model to study the pharmacoeconomic outcomes associated with therapeutic strategies that did or did not include pharmacogenetic testing. Cost per responder at 3 months was the typical primary endpoint. The most compelling iteration was a clinical strategy that used Kineret as the initial anti-cytokine therapy versus a clinical strategy that begins with a pharmacogenetic test. When beginning with a pharmacogenetic test, Kineret was prescribed only if the test predicted response by virtue of the patient carrying +4845. The model incorporated alternative strategies, including use of biologic agents in various sequences and Kineret use only in anti-TNFa failures.
Use of pharmacogenetic testing resulted in a 35% overall savings and a 17% cost per responder savings. If 59% of patients carry +4845, the 3-month cost was $3764 for a non-profiled population and $2421 for a profiled population. The 3-month costs per responder were $7842 for a non-profiled population and $6513 for a profiled population. Sensitivity analyses showed that the model was robust for a population allele frequency variation between 2% and 90%.
The overall data set supported the use of pharmacogenetics as a cost-effective means of assisting in RA drug selection, especially as it relates to Kineret. Interleukin’s approach to the pharmacogenetics of RA supports national efforts to address scientific, clinical, and pharmacoeconomic goals in RA. Predicting therapeutic response to RA medications will not only improve the quality of life for patients, but will also reduce the costs associated with prescribing non-beneficial, even detrimental, medication.
Pharmacogenomics and pharmacogenetics will have a major impact on the future of medicine. The FDA is promoting the use of pharmacogenomics in clinical trial design to allow inclusion of patients most likely to benefit and least likely to experience adverse responses to developmental therapeutics. In addition, several pharmacogenomics studies are investigating response to marketed therapeutics. Besides Interleukin’s RA study, Genaissance (NASDAQ:
GNSC) is conducting trials to correlate genetic variation with response to cholesterol-lowering drugs and anti-psychotic drugs. Even though pharmacogenomics holds substantial clinical promise, whether companies pursuing a pharmacogenomics-based businesses can develop a sustainable business model is still unclear. |
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