Background Adult studies suggest antibodies to infliximab (ATI) correlate with loss of response in inflammatory bowel disease but pediatric data are limited. Methods We conducted a cross-sectional study of trough infliximab levels and ATI in 134 pediatric and young adult patients receiving infliximab. At the time serum was obtained demographics, disease phenotype, duration of infliximab therapy, use of combination therapy (methotrexate or 6-mercaptopurine with infliximab), and surgery were recorded. Results Assays were performed on 134 subjects currently receiving infliximab (85 male; mean age, 17.3 ± 4.3 years; 114 Crohn’s disease and 20 ulcerative colitis). Infliximab use ranged from 12 days to 12 years: median 2.0 (interquartile range [1.1–4.3]) years. Twenty-seven of 134 (20%) patients had ATI ≥5 U/mL. Of patients with ATI ≥5 U/mL, 59% had infliximab levels <5 μg/mL, compared with 14% of patients with ATI <5 U/mL (P < 0.001). Ten (7%) patients (9 Crohn’s disease, 1 ulcerative colitis) underwent bowel resections after beginning infliximab infusions. Sixty percent who underwent surgery had ATI ≥12 U/mL; in contrast, only 8% of patients who did not undergo surgery had ATI ≥12 U/mL (P = 0.01). At the time of serum sampling, 50 (37%) patients were receiving combination therapy, compared with 84 (63%) on infliximab alone. Combination therapy at the time of serum sampling did not correlate with either increase infliximab levels or lower ATI compared with infliximab monotherapy. However, prior immunomodulator use was associated with lower antibody levels (P = 0.007). Conclusions ATI correlates with reduction in infliximab level and a higher risk of surgery in patients with inflammatory bowel disease.

Objective We describe our approach to surveillance of reportable safety events captured in hospital data including free-text clinical notes. We hypothesize that a) some patient safety events are documented only in the clinical notes and not in any other accessible source; and b) large-scale abstraction of event data from clinical notes is feasible. Materials and Methods We use regular expressions to generate a training data set for a machine learning model and apply this model to the full set of clinical notes and conduct further review to identify safety events of interest. We demonstrate this approach on peripheral intravenous (PIV) infiltrations and extravasations (PIVIEs). Results During Phase 1, we collected 21,362 clinical notes, of which 2342 were reviewed. We identified 125 PIV events, of which 44 cases (35%) were not captured by other patient safety systems. During Phase 2, we collected 60,735 clinical notes and identified 440 infiltrate events. Our classifier demonstrated accuracy above 90%. Conclusion Our method to identify safety events from the free text of clinical documentation offers a feasible and scalable approach to enhance existing patient safety systems. Expert reviewers, using a machine learning model, can conduct routine surveillance of patient safety events.

Inflammatory bowel diseases, including Crohn disease and ulcerative colitis, are most often diagnosed during adolescence and young adulthood, with a rising incidence in pediatric populations. Infliximab is an effective treatment option for Crohn disease and ulcerative colitis. The most common adverse event with infliximab is an infusion reaction. Patients are often treated prophylactically with combinations of acetaminophen, intravenous steroid, and an antihistamine to prevent an infusion reaction. There is a high degree of practice variation regarding pretreatment for infliximab infusions, the efficacy of pretreatment with an antihistamine is unproven in preventing infusion-related reactions, and there is no national clinical standard. Unnecessary pretreatment in adolescence and young adulthood may be harmful, as this is a time to focus on developing self-care management skills. Antihistamine side effects including somnolence and dizziness may adversely affect adolescents and/or young adults' ability to complete schoolwork, drive, and transition toward autonomous management of their chronic illness. This report presents the findings of an evidence-based practice project reviewing the efficacy of pretreatment with an antihistamine in patients with Crohn disease and ulcerative colitis receiving infliximab. Practice implications are discussed.