Clinical efficacy of infliximab level and anti-infliximab antibody measurement in patients with inflammatory bowel disease: An audit.

BACKGROUND AND AIMS: Infliximab (IFX) monitoring has been proposed for effective therapeutic management of inflammatory bowel disease (IBD). There is no data on infliximab levels and its antibody measurement in Indian patients. We assessed the clinical efficacy of IFX level and antibodies to infliximab (ATI) monitoring in IBD patients. METHODS: Infliximab trough level and antibody testing was done in 50 and 30 IBD patients, respectively using commercially available enzyme-linked immunosorbent assay (ELISA) kits. The levels were correlated with the disease status, albumin, and C-reactive protein (CRP) levels. The clinical efficacy of level-based change in patient management was evaluated. RESULTS: Of 50 patients, IFX levels were therapeutic in 8, sub-therapeutic in 40, and supra-therapeutic in 2. High ATI titer was present in 8/30 patients. The IFX level did not correlate with the dose of 5 or 10 mg/kg. Based on IFX level and ATI estimation, management was changed in 35 patients: increase in dose in 7, decrease in dosing interval in 17, increase in interval in 2, surgery in 2, change in biologic in 5, and cessation of IFX in 2 patients. Therapy modification based on IFX level improved the clinical response in 25 patients, of whom 5 are in remission at a median duration of 2 years. CONCLUSION: Most (80%) of the IBD patients had subtherapeutic IFX levels while high ATI titers were found in 27% of the patients. There was no correlation between infliximab dose and drug levels. Therapy modification based on drug level benefitted the majority. Our results suggest that measurement of IFX level assists in attaining therapeutic levels and improves clinical response.

Influence of blood specimen collection method on various preanalytical sample quality indicators.

Preanalytical errors contribute to a large proportion of total laboratory errors. In order to achieve continuous laboratory improvement, it is important to focus on all phases of patient specimen testing i.e. preanalytical, analytical and post-analytical. With large variations in the way venous blood specimens are collected using diverse devices in the country, the effect of such practices on specimen quality is not known. The purpose of this study was to monitor fourteen specimen preanalytical quality indicators in order to compare the usage of evacuated blood collection devices with needle and syringe open collection using either disposable tubes or re-washed glass vials. The study involved 26638 patient specimens assessed over a period of 6 months. The results demonstrated that evacuated closed blood collection resulted in an approximate 100-fold reduction in the incidence of hemolysis in samples. Similarly, there was a 200-fold reduction in incidence of insufficient specimen quantity while using evacuated collection system. It was also found that incidence of specimen contamination, improper volume of sample collected, and specimen spillage was also lower when the evacuated collection system was used. Further, it was also observed that the facility with a laboratory information system demonstrated much lower specimen identification and related errors. The observed results clearly demonstrate that the usage of the evacuated blood collection system resulted in improvement of preanalytical specimen quality as compared to needle and syringe usage.