Study evaluates the Impact of Trough Level-Based Infliximab Dosing on Clinical and Endoscopic Remissions in Patients with IBD
October 13, 2016 (Atlanta and Chicago) – Northwestern University Feinberg School of Medicine and Curant Health have announced a new prospective study entitled, “A Collaborative Study to Evaluate the Efficacy of Prospective Post-Induction Infliximab Dosing Based on Trough Levels at week 12 and 28 in Subjects with Crohn’s Disease (CD) and Ulcerative Colitis (UC).” Patients starting therapy with the anti-tumor necrosis factor (TNF) infliximab will be enrolled in the study and will have their infliximab dose adjusted based on trough level at weeks 12 and 28 of treatment per protocol. This study will measure steroid-free clinical remission, mucosal healing and total dose of infliximab over 52 weeks.
IBD, including Crohn’s disease (CD) and ulcerative colitis (UC), is a chronic, debilitating condition that can have important economic and clinical implications. IBD is associated with high morbidity, loss of work productivity and impaired quality of life. The Centers for Disease Control and Prevention states that total annual direct and indirect costs associated with IBD were more than $11.8 billion in 2008.
“Low or undetectable infliximab levels have been associated with worse clinical outcomes and secondary loss of efficacy in IBD. This often results in discontinuation of infliximab or switching to another agent within class,” said Dr. Stephen Hanauer, MD, Clifford Joseph Barborka Professor of Medicine at Northwestern University Feinberg School of Medicine and Medical Director of the Northwestern Medicine Digestive Health Center. “We speculate that proactively adjusting infliximab dosing to achieve therapeutic levels will improve clinical and endoscopic remissions in our IBD patients, and we are eager to see the impact our study has on guiding management of IBD patients on anti-TNF agents.”
Curant Health will monitor patient compliance to therapy, guide patients on prednisone tapers, document adverse events, evaluate disease activity and coordinate the transfer of testing results to clinicians for evaluation and dose adjustments.
“Our patient support services, including Enhanced Medication Therapy Management (MTM), bring near clinical trial conditions to real world care,” said Curant Health’s Health Systems Specialist, Jason Canfield. “We are confident this study will further validate the value of our support services for care of patients with chronic conditions like IBD.”
About Curant Health
The team of healthcare experts at Curant Health provide individualized, patient-centered services proven to deliver improved health outcomes including individualized medication management therapies and continuous, consistent patient care, education and support. In 2016 Curant Health ranked #7 on the Inc. 500|5000 for fastest growing, large healthcare companies.