Therapeutic drug monitoring in patients on biologics: lessons from gastroenterology.

PURPOSE OF REVIEW

To give an overview on the role of therapeutic drug monitoring (TDM) of biologics in patients with inflammatory bowel disease (IBD).

RECENT FINDINGS

Numerous prospective exposure-response relationship studies and post-hoc analyses of randomized controlled trials (RCTs) show a positive correlation between biologic drug concentrations and favorable clinical outcomes in IBD. These studies also demonstrate that higher drug concentrations appear to be needed to achieve more stringent objective therapeutic outcomes. Reactive TDM rationalizes the management of primary nonresponse and secondary loss of response to antitumor necrosis factor (anti-TNF) therapy and is more cost-effective when compared with empiric dose optimization. Furthermore, recent data suggest that proactive TDM, with the goal of targeting a threshold drug concentration, is associated with better therapeutic outcomes when compared with empiric dose escalation and/or reactive TDM of infliximab or adalimumab. Finally, proactive TDM can also efficiently guide infliximab de-escalation or discontinuation in patients with IBD in remission.

SUMMARY

Reactive TDM is currently considered as standard of care, whereas proactive TDM is emerging as a new therapeutic strategy for better optimizing anti-TNF therapy in IBD. However, more data from prospective studies are needed before a wide implementation of TDM-based algorithms in real life clinical practice for newer biologics.