At a glance
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Association of Golimumab Trough Levels With Endoscopic and Histologic Healing in Patients With Ulcerative Colitis
In Brief
An observational study evaluating Golimumab trough levels, Antibodies to golimumab, and 2 other interventions for Ulcerative Colitis. Completed, enrolled 52 participants across 12 sites.
Detailed Summary
Proactive therapeutic drug monitoring of Anti-TNFs with drug titration to a therapeutic window is associated with favorable long-term therapeutic outcomes in IBD and may be superior to reactive therapeutic drug monitoring. Moreover, many exposure-response relationship studies have shown that higher serum anti-TNF drug concentrations are associated with better clinical outcomes in IBD, suggesting that it is maybe time to go from a 'treat-to-target' to a 'treat-to trough' therapeutic approach. In this scenario, there are very limited data regarding therapeutic drug monitoring with golimumab in UC and even no data regarding a therapeutic window to target for important objectives outcomes like mucosal healing and histological remission.
Study Details
Timeline
Interventions
Golimumab trough levels taken immediately before the administration of the next subcutaneous dose of golimumab
Antibodies to golimumab taken immediately before the administration of the next subcutaneous dose of golimumab
Histology of colonic biopsies using the Geboes Index
Colonoscopy to evaluate the endoscopic activity by a Mayo endoscopic subscore