Limits...
The Utility of Infliximab Therapeutic Drug Monitoring among Patients with Inflammatory Bowel Disease and Concerns for Loss of Response: A Retrospective Analysis of a Real-World Experience

View Article: PubMed Central - PubMed

ABSTRACT

Background. Infliximab (IFX) therapeutic drug monitoring (TDM) allows for objective decision making in patients with inflammatory bowel disease (IBD) and loss of response. Questions remain about whether IFX TDM improves outcomes. Methods. Patients with IBD who had IFX TDM due to concerns for loss of response were considered for inclusion. Serum IFX trough concentration and anti-drug antibody (ADA) concentrations were measured. Patients were grouped by TDM results: group 1, low IFX/high ADA; group 2, low IFX/low ADA; group 3, therapeutic IFX. Changes in management were analyzed according to groupings; remission rates were assessed at 6 months. Results. 71 patients were included of whom 37% underwent an appropriate change in therapy. Groups 1 (67%) and 2 (83%) had high adherence compared to only 9% in group 3. At 6 months, 57% had achieved remission. More patients who underwent an appropriate change in therapy achieved remission, though this did not reach statistical significance (69% versus 49%; P = 0.098). Conclusions. A trend towards increased remission rates was associated with appropriate changes in management following TDM results. Many patients with therapeutic IFX concentrations did not undergo an appropriate change in management, potentially reflecting a lack of available out-of-class options at the time of TDM or due to uncertainty of the meaning of the reported therapeutic range.

No MeSH data available.


Related in: MedlinePlus

Therapeutic drug monitoring decision algorithm in inflammatory bowel disease patients on infliximab with concerns for loss of response.
© Copyright Policy
Related In: Results  -  Collection

License
getmorefigures.php?uid=PMC5121455&req=5

fig1: Therapeutic drug monitoring decision algorithm in inflammatory bowel disease patients on infliximab with concerns for loss of response.

Mentions: Historically, physicians treating patients with secondary loss of response have relied on intuition and pragmatism to choose between dose optimization of IFX [10] or switching to an alternative biologic agent [11]. Recently, with the emergence of laboratory testing for IFX and ADA in serum, patients who suffer loss of response to IFX have guidance in making an objective therapeutic decision. It has been demonstrated that patients with low IFX trough concentrations and the presence of significant amounts of ADA generally have worse clinical outcomes, including lower rates of clinical response and poorer mucosal healing [6, 12]. Based on trough serum IFX and ADA concentrations, patients with secondary loss of response have been divided into three groups: group 1, high ADA and low IFX; group 2, low ADA and low IFX; and group 3, therapeutic IFX [13]. Based on these groupings, benefit has been demonstrated when patients in group 1 switch to an alternative anti-TNFα agent, group 2 undergo IFX dose optimization, and group 3 switch to an out-of-class biologic agent if available [14–16] (Figure 1).


The Utility of Infliximab Therapeutic Drug Monitoring among Patients with Inflammatory Bowel Disease and Concerns for Loss of Response: A Retrospective Analysis of a Real-World Experience
Therapeutic drug monitoring decision algorithm in inflammatory bowel disease patients on infliximab with concerns for loss of response.
© Copyright Policy
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC5121455&req=5

fig1: Therapeutic drug monitoring decision algorithm in inflammatory bowel disease patients on infliximab with concerns for loss of response.
Mentions: Historically, physicians treating patients with secondary loss of response have relied on intuition and pragmatism to choose between dose optimization of IFX [10] or switching to an alternative biologic agent [11]. Recently, with the emergence of laboratory testing for IFX and ADA in serum, patients who suffer loss of response to IFX have guidance in making an objective therapeutic decision. It has been demonstrated that patients with low IFX trough concentrations and the presence of significant amounts of ADA generally have worse clinical outcomes, including lower rates of clinical response and poorer mucosal healing [6, 12]. Based on trough serum IFX and ADA concentrations, patients with secondary loss of response have been divided into three groups: group 1, high ADA and low IFX; group 2, low ADA and low IFX; and group 3, therapeutic IFX [13]. Based on these groupings, benefit has been demonstrated when patients in group 1 switch to an alternative anti-TNFα agent, group 2 undergo IFX dose optimization, and group 3 switch to an out-of-class biologic agent if available [14–16] (Figure 1).

View Article: PubMed Central - PubMed

ABSTRACT

Background. Infliximab (IFX) therapeutic drug monitoring (TDM) allows for objective decision making in patients with inflammatory bowel disease (IBD) and loss of response. Questions remain about whether IFX TDM improves outcomes. Methods. Patients with IBD who had IFX TDM due to concerns for loss of response were considered for inclusion. Serum IFX trough concentration and anti-drug antibody (ADA) concentrations were measured. Patients were grouped by TDM results: group 1, low IFX/high ADA; group 2, low IFX/low ADA; group 3, therapeutic IFX. Changes in management were analyzed according to groupings; remission rates were assessed at 6 months. Results. 71 patients were included of whom 37% underwent an appropriate change in therapy. Groups 1 (67%) and 2 (83%) had high adherence compared to only 9% in group 3. At 6 months, 57% had achieved remission. More patients who underwent an appropriate change in therapy achieved remission, though this did not reach statistical significance (69% versus 49%; P = 0.098). Conclusions. A trend towards increased remission rates was associated with appropriate changes in management following TDM results. Many patients with therapeutic IFX concentrations did not undergo an appropriate change in management, potentially reflecting a lack of available out-of-class options at the time of TDM or due to uncertainty of the meaning of the reported therapeutic range.

No MeSH data available.


Related in: MedlinePlus