Multi-utility of therapeutic drug monitoring in inflammatory bowel diseases

Abstract

Inflammatory bowel disease (IBD) treatment targets have progressed over time from clinical response to clinical and endoscopic remission. Several data have shown a positive correlation between serum biologic drug concentrations and favorable therapeutic outcomes. Therapeutic drug monitoring (TDM) has evolved as an important approach for optimizing the use of immunobiologics, especially antitumor necrosis factor therapy, in patients with IBD. The use of TDM is supported by medical societies and IBD experts in different contexts; however, challenges remain due to knowledge gaps that limit the widespread use of it. The aim of this review is to assess the role of TDM in IBD, focusing on the implementation of this strategy in different scenarios and demonstrating the multi-utility aspects of this approach in clinical practice.

Editorial: proactive anti‐TNF drug monitoring in IBD—Ready for the prime time? Authors' reply

“…Furthermore, TDM use will need to diversify and expand its knowledge-base, as we increasingly use non-anti-TNF agents such as vedolizumab, ustekinumab and tofacitinib. 7,8 Thus, we conclude that whilst the efficacy data for TDM use in IBD has been demonstrated in our meta-analyses, we must now shift our focus to developing a standardised assay and set the testing frequency to enhance its generalisability in clinical practice. We must also build evidence-based knowledge on the health economics of TDM and its use in other biologics.…”

“…A cost analysis of undergoing frequent blood tests with patient‐related outcome measurements will help provide clarity on the timing and necessity of TDM use. Furthermore, TDM use will need to diversify and expand its knowledge‐base, as we increasingly use non‐anti‐TNF agents such as vedolizumab, ustekinumab and tofacitinib 7,8 …”

Recent Advances in the Optimization of Anti-TNF Treatment in Patients with Inflammatory Bowel Disease

“…Increased, within predefined therapeutic ranges, drug concentrations are associated with positive disease outcomes. Notably, there is a positive correlation between higher TCs and the clinical and/or endoscopic response and remission, mucοsal healing, lower relapse rates, fewer complications, fewer hospitalizations and fewer disease-related surgeries [ 11 , 12 , 13 , 14 , 15 , 16 ]. Moreover, optimal TCs are associated with a remarkable improvement in the patients’ quality of life, which is one of the long-term targets set out in the recent STRIDE (selecting therapeutic targets in inflammatory bowel disease) consensus [ 17 ].…”

“…Additionally, they enable earlier identification of potential positive cases, offering time for the clinician to act and optimize the therapy preventing an unlikely event of LOR [ 26 ]. In detail, the detection of transient or low-concentration Abs can be managed by treatment optimization (dose escalation, dose interval shortening and/or the addition of an immunomodulator), whereas usually the presence of higher titer Abs can lead, inevitably, to undetectable or low drug concentrations, infusion reactions and treatment failure [ 16 ].…”

“…Based on the significant evidence in favor of the value of TCs of anti-TNFs in IBD management, the therapeutic drug monitoring (TDM) approach has gained attention during the last decade in clinical practice. According to this practice, TCs and Abs are measured and treatment is adjusted with the aim of reaching the TCs within a therapeutic range [ 16 ]. Evidently, it is a way to maintain an adequate dose and, therefore, enhance drug efficacy, prolong response durability and avoid complications.…”