Date: 2015-04-29
Type of information: Publication of results in a medical journal
phase:
Announcement: publication of results in the Journal of Crohn’s and Colitis
Company: Theradiag (France)
Product: monitoring of biotherapies with LISA TRACKER combined to CRP dosing
Action mechanism:
Disease: inflammatory bowel disease
Therapeutic area: Inflammatory diseases - Gastrointestinal diseases
Country:
Trial details:
Latest
news: * On April 29, 2015, Theradiag, a company specializing in theranostics and in vitro diagnostics, announced that a study published in the Journal of Crohn’s and Colitis shows that monitoring of trough levels of infliximab, stable antibodies to infliximab and C-Reactive Protein (CRP) can predict loss of response in Inflammatory Bowel Disease (IBD) patients (X. Roblin et al., Combination of C-reactive Protein, infliximab trough levels and stable but not transient antibodies to infliximab are associated with loss of response to infliximab in inflammatory bowel disease, Journal of Crohn’s and Colitis, April 19, 2015)
“Prediction of loss of response is a key aspect in IBD given the number of patients who become resistant to treatment in the course of the disease, sometimes in less than 12 months. We have identified optimal biological cut-off values which can be used in clinical practice to better manage IBD patients” commented Professor Xavier Roblin, M.D., the principal investigator of the study.
Prof. Roblin’s team at Saint-Etienne University Hospital conducted a prospective study in 93 patients suffering from Crohn’s Disease and Ulcerative Colitis, who had been treated by infliximab and had entered into clinical remission at the time of study. They identified a suggested algorithm predictive of loss of response based on three factors:
- Trough levels of infliximab (TRI) <5,5µg/ml;
- Presence of stable antibodies to infliximab (ATI)[2];
- Level of CRP >5mg/l.
Patients presenting all three factors were at a high risk of losing response to treatment. Loss of response implied the return of disease symptoms requiring an increase or a change in therapy or surgery.
Two of the three factors identified in the algorithm were measured using Theradiag’s LISA TRACKER Infliximab kits.
The study further emphasized the need to include regular monitoring of trough levels of infliximab and detect the presence of stable antibodies to infliximab when managing infliximab-treated IBD patients.
