Medico-economic Evaluation of the Therapeutic Drug Monitoring of Anti-TNF-? Agents in Inflammatory Bowel Diseases

Summary

Participation Requirements

Description

280 patients with Crohn's disease (CD) or ulcerative colitis (UC) will be recruited in 13 french centers and randomized in 2 groups with or without drug and ADAbs monitoring. Anti-TNF inhibitors and ADAbs will be simultaneously measured in the patients serum by ELISA (LisaTracker - Theradiag) at wee...

280 patients with Crohn's disease (CD) or ulcerative colitis (UC) will be recruited in 13 french centers and randomized in 2 groups with or without drug and ADAbs monitoring. Anti-TNF inhibitors and ADAbs will be simultaneously measured in the patients serum by ELISA (LisaTracker - Theradiag) at weeks 6 and 24, months 4, 8, 12, 16, 20 and 24. In the unmonitored group, drug and ADAbs measurements will not be transmitted to the clinician. In the monitored group, in case of loss of response the clinician will use immunomonitoring data to adapt the treatment following a simple treatment algorithm: loss of response with therapeutic serum trough level of anti-TNF switch to another biologic loss of response with subtherapeutic serum trough level of anti-TNF but without detectable ADAbs increase doses and/or shorten interval between infusions loss of response with subtherapeutic serum trough level of anti-TNF and detectable ADAbs switch to another anti-TNF if inefficient switch to another biologic. Clinical and economical benefits of the biological monitoring will be evaluated after a follow-up period of two years: primary outcome: Cost-utility analysis of the immunomonitoring strategy using incremental cost effectiveness ratio secondary outcome: Evaluation of the quality of life (IBDQ score)

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