Proactive therapeutic drug monitoring and vedolizumab dose optimization in children with inflammatory bowel disease.

OBJECTIVES: Therapeutic drug monitoring (TDM) and dose optimization have been shown to improve clinical outcomes with antitumor necrosis factor and recent studies in adults suggest an exposure-response relationship with drug levels associated with improved clinical outcomes. However, these levels are not universally recognized as therapeutic targets for vedolizumab dosing. We aimed to assess the impact of a TDM quality improvement (QI) initiative on 52-week clinical outcomes and describe proactively obtained vedolizumab levels during the induction period in children with inflammatory bowel disease (IBD). METHODS: A QI initiative to proactively obtain TDM levels at Week 6 was implemented in 2019. A retrospective review of pediatric patients with IBD treated with vedolizumab from 2018 to 2022 was performed. Baseline demographic data, medication dosing details, disease characteristics, lab results, and 12-month clinical outcomes were recorded. For this study, we defined therapeutic target levels (>20 µg/mL at Week 6 and >12 µg/mL during maintenance) based on existing data correlating these levels with improved clinical outcomes. RESULTS: Fifty-nine patients (31 Crohn disease [CD], 28 ulcerative colitis [UC]/indeterminate colitis [IC]) were included in the study. In total, 68% (40/59) of patients had vedolizumab levels at Week 6 and 90% (53/59) had levels drawn at Week 6 or 14. Thirty-five percent of Week 6 trough levels were below our defined target of 20 µg/mL. Fifty-two of 59 patients had available data at 52 weeks. Over 80% (42/52) of patients remained on vedolizumab 52 weeks after initiation (CD 79% [23/29], UC/IC 83% [19/23]). Sixty-two percent (26/42) of patients that remained on vedolizumab at 52 weeks were treated with an intensified dosing interval of <8 weeks. Thirty-one of these 42 (74%) were in clinical remission (CR) rate at 52 weeks with 29/42 (69%) in corticosteroid-free remission. The CR rate for the entire cohort including those who discontinued therapy due to a lack of efficacy before 52 weeks was 60% (31/52). CONCLUSION: Proactive TDM and early dose optimization with vedolizumab may improve drug durability and clinical outcomes in pediatric patients with IBD.

Single-Center Analysis of Essential Laboratory Testing in Patients with Newly Diagnosed Celiac Disease.

OBJECTIVE: To analyze laboratory testing results from pediatric patients newly diagnosed with celiac disease to determine the usefulness of each test derived from recommended guidelines. METHODS: Serological testing at the time of diagnosis from patients enrolled in our celiac disease registry from January 2018 through December 2021 was reviewed. The incidence of abnormal laboratory results, routinely obtained as per the recommendations of Snyder et al and our institution's Celiac Care Index, was assessed. Rates of abnormal laboratory values and estimated costs associated with these screening measures were analyzed. RESULTS: Our data demonstrated abnormalities in all serological testing obtained at celiac diagnosis. Hemoglobin, alanine aminotransferase, ferritin, iron, and vitamin D screening were found to be abnormal with notable frequency. Only 7% of patients had an abnormal thyroid-stimulating hormone and <0.1% had an abnormal free T4. Nonresponse to hepatitis B vaccination was prominent, with 69% of patients considered nonimmune. Screening protocols as currently outlined in our Celiac Care Index resulted in an estimated cost of approximately $320 000 during our study. CONCLUSIONS: Review of screening laboratory results at our center reveals that abnormal values for several recommended measures are uncommon. Thyroid screening was infrequently abnormal and the usefulness of screening for hepatitis B at diagnosis is uncertain. Similarly, our data suggest that iron deficiency screening may be condensed effectively into hemoglobin and ferritin testing, eliminating the need for initial iron studies. Decreasing baseline screening measures could safely decrease the burden of testing on patients and overall healthcare expenditures.

A Celiac Care Index Improves Care of Pediatric Patients Newly Diagnosed with Celiac Disease.

OBJECTIVES: To describe quality improvement efforts to reduce variability in the care of children diagnosed with celiac disease through use of an institutional patient registry and a chronic care index. STUDY DESIGN: An institutional patient registry tracked rates of follow-up visits and repeat serologic testing. A Celiac Care Index that included anthropometrics, biopsy expectations, dietician consultation, and baseline laboratory evaluation was developed to standardize evaluation at diagnosis. Provider education sessions communicated expectations for this standard of care and order sets within the electronic medical record simplified test collection. Data was recorded and reviewed weekly and structured communications with providers were provided biweekly. RESULTS: Adherence with follow-up expectations (77%-89% P = .03) and repeat serologic testing (50%-90% P < .0001) significantly increased during the study period. Adherence with completion of the Celiac Care Index resulted in significant improvement in obtaining complete blood count (80%-98% P < .0001), iron (25%-78% P < .0001), ferritin (34%-80% P < .0001), alanine aminotransferase/aspartate aminotransferase (74%-96% P < .0001), thyroid-stimulating hormone (64%-90% P < .0001), vitamin D (36%-83% P < .0001), and hepatitis B immune status (30%-80% P < .0001). Iron deficiency demonstrated by low ferritin levels was common (41%) and a high rate of nonimmunity to hepatitis B (70%) was detected. CONCLUSIONS: The Celiac Care Index improved adherence with published care recommendations and reduced variability in baseline evaluation at diagnosis. Laboratory test results indicate further studies are needed to evaluate these recommendations.