ABSTRACT
BACKGROUND: Therapeutic drug monitoring (TDM) by measuring infliximab (IFX) trough levels and antibodies to infliximab (ATI) is used to optimise treatment in inflammatory bowel disease. We aimed to explore the clinical outcomes of TDM for patients with Crohn's disease on IFX in real life setting. METHODS: This is a retrospective observational study. Primary outcomes were the clinicians' response to each TDM result and the rate of IFX discontinuation due to secondary loss of response or serious adverse event. Secondary outcomes included the intestinal surgery rate after IFX initiation and remission 6 months after TDM. Multivariate logistic regression was performed to identify factors associated with IFX discontinuation and abdominal surgery. RESULTS: 291 patients were included. 238 (81.8%) patients were tested for TDM at least once during their follow-up with 672 TDM results. 95/238 patients (39.9%) had undetectable levels and 76 (31.9%) had positive ATI at least once. The median infliximab trough level was 3.4 µg/mL. IFX was discontinued in 109 patients (37.5%). 526/672 (78.3%) TDMs results were not followed by altered patient management. Treatment was discontinued in 40 (75.5%) patients never tested for TDM compared with 69 (29.0%) of those tested (p<0.01). Fewer TDM tested patients (29; 12.2%) required intestinal surgery post IFX initiation compared with TDM not-tested (15; 28.3%). Not being TDM tested was independently associated with IFX discontinuation and abdominal surgery. CONCLUSIONS: IFX discontinuation and intestinal surgery were significantly less frequent with TDM. TDM requested to investigate loss of response resulted in change in patient management.
ABSTRACT
BACKGROUND: Inflammatory bowel disease (IBD) is a chronic relapsing-remitting condition affecting 600 000 people in the UK. Traditionally, patients attend outpatient clinics for monitoring regardless of their symptoms or risk of developing complications. This can lead to a mismatch between need and access: patients in remission given elective appointments displace those in need of urgent specialist attention. Novel initiatives implemented in the UK to improve outpatient monitoring have often required a well-maintained patient registry, empowered patients and significant information technology support. DESIGN AND STRATEGY: In this large-scale quality improvement project at St Mark's Hospital, a tertiary centre for IBD, we stratified over 1000 patients attending three non-complex IBD clinics over 12 months according to disease activity and risk profile. The aim was to offer a choice and subsequently transfer 50% of eligible patients to specialist nurse-led telephone clinics and demonstrate non-inferior satisfaction levels to existing outpatient follow-up. We also sought to ensure there was timely access to a newly established rapid access clinic for patients requiring urgent specialist attention.A core project team consisting of healthcare professionals, patients and quality improvement scientists met regularly. The team tested and scaled up interventions using 'Plan-Do-Study-Act' cycles within the 'Model for Improvement' framework and analysed data continuously using statistical process charts. RESULTS: Over 12 months, the average number of eligible patients transferred to telephone clinics rose from 17.6% (42/239) using a questionnaire method to 59.3% (73/123) using active discussion in clinic. Patient satisfaction scores remained high and non-inferior to baseline scores in face-to-face clinics. The median waiting time to be seen in the rapid access clinic was 6.5 days. CONCLUSION: This is the first published study to report on the successful stratification of patients with IBD based on disease activity and risk of complications to create a more responsive, sustainable and patient-centred model for IBD monitoring.
