The effects of proactive therapeutic drug monitoring vs reactive therapeutic drug monitoring in a virtual biologic clinic, a retrospective cohort study

Abstract

Summary Background Proactive therapeutic drug monitoring (proactive‐TDM) to optimise maintenance infliximab (IFX) trough levels prior to loss of response reduces the risk of treatment failure, inflammatory bowel disease (IBD)‐related surgery and hospitalisation when compared with reactive monitoring (reactive‐TDM). Aim The aim of this study is to investigate if proactive‐TDM in a virtual biologic clinic (VBC) improves patient disease control determined by number of hospital admissions, surgeries, patient reported outcome measures (PROMs) and biomarkers of disease activity. Methods We conducted a single‐centre retrospective observational study. Data were collected from commencement of the VBC in June 2016 to September 2017. All IBD patients on IFX in the VBC were included. PROMs were recorded using the IBD‐Control‐8 sub‐score and Visual Analogue Scale. Results One hundred and twenty‐three patients were included in the study. A statistically significant improvement in faecal calprotectin was observed with proactive‐TDM with a P‐value <.001. There was a 59% reduction in crisis IBD admissions with the introduction of proactive‐TDM in the VBC (P‐value <.005). Dose de‐escalations in the first 3 months of the VBC lead to cost savings of €32 000 per annum. Conclusions The introduction of proactive‐TDM resulted in a significant reduction in hospital admissions, an increase in mean IFX trough levels, a significant improvement in faecal calprotectin and adjustment to therapy in 33% of patients. Proactive‐TDM in the setting of a VBC is a method of managing IBD patients on IFX therapy with the potential for significant cost savings.

Meta‐analysis: The efficacy of therapeutic drug monitoring of anti‐TNF‐therapy in inflammatory bowel disease

“…Nine were RCTs 17,19,20,[29][30][31][32][33][34] and the remaining were cohort studies. There were four prospective cohort studies, [35][36][37][38] 11 retrospective cohort studies [6][7][8]18,27,[39][40][41][42][43][44] and two that were both prospective and retrospective cohort studies. 5,45 Table 1 shows a summary of the studies.…”

“…Four studies were eligible for the proactive vs reactive arm, with 352 patients in the proactive TDM arm and 368 in the reactive TDM arm 6,7,36,39 . Proactive TDM was associated with a significant risk reduction in hospitalisation (RR 0.33, 95% CI 0.21-0.54, p<0.01, 9).…”

Dose escalation of vedolizumab in inflammatory bowel disease patients with secondary loss of response

“…However, hard evidence that this strategy actually works is hard to find. In the case of anti‐TNFs, there is now very good evidence that therapeutic drug monitoring (TDM) greatly assists the physician in selecting the appropriate dosing for the patient 2 . TDM for vedolizumab is not widely available and its efficacy and utility in managing the patient with loss of response is not well established yet.…”

Editorial: proactive therapeutic drug monitoring in treatment of inflammatory bowel disease: it makes sense

“…It may seem to be self‐fulfilling prophecy that by proactively monitoring drug levels and antibodies in biological therapy, physicians can achieve better disease control . However, even the most obvious treatment propositions need to be demonstrated by a prospective study.…”

“…In the previous issue of GastroHep, Tun et al demonstrated that there is a high prevalence of positive antibodies to infliximab (ATI) post‐induction and is associated with a high rate of rapid treatment failure . In this issue, McGettigan et al conducted a prospective cohort study following the clinical course of two groups of patients, one with reactive monitoring and the other with proactive drug monitoring …”