Combination testing may identify who benefits from dose optimization in Crohn’s
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Among patients with Crohn’s disease, combination testing of the endoscopic healing index and anti-tumor necrosis factor concentration may identify patients who benefit from dose escalation, according to data from Digestive Disease Week.
“This is a hypothesis generating study using mined data from a large commercial clinical laboratory database,” Maria T. Abreu, MD, from the University of Miami Miller School of Medicine, said during her virtual presentation. “We propose combined measurement of endoscopic healing index [EHI] scores with anti-TNF concentrations could provide an accurate and non-invasive approach to identify who could benefit from management change from dose optimization.”
Abreu and colleagues selected 1,444 patients with an ICD-10 code for Crohn’s disease and EHI and anti-TNF concentration results available within 30 days of each other. In this cohort, 591 patients received infliximab (Remicade, Janssen) and 853 received adalimumab (Humira, AbbVie). Investigators examined the association between the EHI and anti-TNF concentration. They considered an EHI less than 20 as considered highly associated with endoscopic remission and an EHI greater than 50 with active endoscopic disease. To identify anti-TNF concentration thresholds with combined maximum sensitivity and specificity to discriminate EHI less than 20 from EHI greater than 50, investigators evaluated receiver operating characteristic curves.
Researchers reported a linear inverse relationship between median EHI in both infliximab and adalimumab concentration quartiles (P < .0001 for both anti-TNF). ROC curves showed thresholds correlated with EHI less than 20 for infliximab greater than 3.45 µg/mL (area under curve = 0.702; sensitivity = 53.1%; specificity = 88%) and for adalimumab greater than 5.95 µg/mL (AUC = 0.682; sensitivity = 59%; specificity = 73.8%).
Abreu and colleagues retrospectively applied combined testing in the infliximab group and found 49% (128/261) of patients had an EHI greater than 50, and that 53.1% (68/128) of those patients had an infliximab concentration of 3.45 µg/mL or less. Investigators reported these patients may benefit from dose escalation. For patients treated with adalimumab, 47.2% (188/398) had an EHI less than 50, and 59% (111/188) of those had an adalimumab concentration of 5.95 µg/mL or less and may also benefit from dose escalation
“The hope would be that future studies could assess the clinical utility prospectively to see if this actually could turn out to be true,” she said. “It’s a topical issue in this time of COVID-19 when we do not have endoscopy freely available to us.” – by Monica Jaramillo
Reference: Abreu MT, et al. Abstract 241. Presented at: Digestive Disease Week; May 2-5, 2020; Chicago (meeting canceled).
Disclosures: Abreu reports she is a consultant for Allergen, Amgen, Boehringer Ingelheim Pharmaceuticals, Celgene Corporation, Eli Lilly Pharmaceuticals, Focus Medical Communications, Pfizer and Prometheus Laboratories, Shire Pharmaceuticals; speaks and teaches for Gilead; is on the advisory committees or review panels; for Janssen Pharmaceuticals; receives grant and research support from Roche Pharmaceuticals and is a consultant for and receives grant and research support from Takeda Pharmaceuticals. Please see the abstract for all other authors’ relevant financial disclosures.