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A gut feeling about biotherapy
CROISSY-BEAUBOURG, France—Theradiag, a company specializing in theranostics and in-vitro diagnostics, announced that a study in Alimentary Pharmacology and Therapeutics demonstrates the predictive role of biotherapy monitoring in the clinical management of inflammatory bowel disease (IBD) patients in deep remission treated with anti-TNF.
Conducted by Dr. Shomron Ben-Horin of the Sheba Medical Center in Israel and Dr. Xavier Roblin of Saint-Etienne Medical Center in France, the study shows that undetectable levels of anti-TNF at drug cessation in patients in long-term remission are associated with low risk of relapse for 12 months after interruption of the treatment. For these patients, anti-TNF discontinuation may be considered. Measurement of drug levels in patient plasma was made possible by theranostics tests.
According to Dr. Valery Labonne, vice president of theranostics at Theradiag, biotherapy monitoring is “an innovative aspect of the field of diagnostics, which aims at improving patient care by providing additional information to the physicians to guide and improve their therapeutic strategy.” It is used today in a variety of therapeutic fields, such as inflammatory bowel disease, rheumatology (rheumatoid arthritis and psoriatic arthritis) and cancer.
Theradiag develops LISA TRACKER, a range of theranostics tests (tests combining treatment and diagnosis), that monitor the efficiency of biotherapies in the treatment of autoimmune and inflammatory diseases and cancer. LISA TRACKER allows the simultaneous dosage of the prescribed biotherapy and of antibodies directed against the biotherapy through an ELISA, from a serum sample. The biological parameter levels enable physicians to optimize, modify or discontinue treatments based on published medical algorithms and a specific patient’s needs.
The study conducted by Ben-Horin and Roblin demonstrates that undetectable levels of anti-TNF at drug cessation in patients in long-term remission are associated with low risk of relapse for 12 months after interruption of the treatment. “That is to say that by measuring the level of anti-TNF levels in patients in remission (as defined by clinical scores) with a theranostics test, it is possible to anticipate relapse risks over a certain period of time (here 12 months),” says Gérard Tobelem, chairman of Theradiag. “Patients in remission with undetectable anti-TNF drug levels have a strong likelihood of long-term remission. On the contrary, patients in remission with detectable anti-TNF have a strong likelihood of relapse.”
Theradiag developed its LISA-TRACKER theranostics tests by applying its 25 years of expertise in the distribution, development and manufacturing of in-vitro diagnostic tests to the monitoring of biotherapies, according to Tobelem. Theradiag is now developing new biomarkers based on microRNAs for the diagnosis and monitoring of rectal cancer, inflammatory and auto-immune diseases and HIV/AIDS—the next generation of theranostics tests.
By anticipating the loss of response to treatment and risks of relapse, theranostics tests dramatically improve the care of patients suffering from IBD, rheumatoid arthritis and all inflammatory and autoimmune diseases treated by biotherapy, according to Theradiag. They also avoid unnecessary use of treatments (in resistant patients, for instance) or overdosing and can, therefore, lead to a significant reduction of healthcare costs. A pharmaco-economic study conducted on Crohn’s Disease by Prof. Gerard Duru and Prof. Michel Lamure in association with gastroenterology experts, including Roblin (presented as a poster titled “Anti-TNFα-optimization: measuring residual levels of anti-TNFα leads to significant reductions in healthcare costs while maintaining at least the same level of clinical efficacy as current therapeutic strategies” at the Francophone Gastroenterology, Liver-Disease and Digestive Cancer meeting in March 2015), showed that theranostics could produce savings of up to 25 percent on the cost of treatment, which would be more than €130 million (more than $143 million) over five years in France alone.
Tobelem concludes, “The results of this study show once again the need to adapt treatment to the specific need of every patient. This approach of personalized medicine has been adopted in cancer, and it is gaining ground in the treatment of autoimmune diseases. The routine use of biotherapy monitoring kits can improve IBD patient care by identifying patients who are at a high or low risk of relapse after interrupting their treatment. It can also reduce the financial burden of IBD. Anti-TNF treatments cost thousands of euros per patient and per year, to which can be added the costs of hospitalization, surgery and medical leave. We must adopt regular use of biological tools to better manage the treatment of patients suffering from autoimmune diseases.”