Ustekinumab Therapeutic Drug Monitoring—Impact on Clinical Practice: A Multicenter Cross-Sectional Observational Trial

Digestive Diseases and Sciences(2021)

Cited 5|Views11
No score
Abstract
Background and Aims The value of ustekinumab (UST) therapeutic drug monitoring (TDM) in clinical practice remains unclear. This study examined the impact of UST TDM on clinical decision making in patients with Crohn’s disease (CD). Methods A total of 110 consecutive UST-treated CD patients were enrolled in this multicenter, single-arm cross-sectional study. During a single study visit, clinical decisions, disease characteristics, and serum and fecal samples were obtained. The primary outcome was congruency of the actual and two hypothetical clinical decisions based on provision of UST TDM (with and without fecal calprotectin [FCP]) to participating clinicians. Decisions were compared against those of a review panel. A sub-study retrospectively measured the associations of clinical outcomes at the next follow-up visit with serum UST concentration [UST]. Results No differences in the pattern of decisions by clinicians were observed before and after provision of UST TDM ( P = 1.0) or UST TDM + FCP ( P = 0.86). However, 39% (TDM) and 50% (TDM + FCP) of hypothetical decisions differed from the initial decisions. The review panel’s decisions differed with the addition of TDM + FCP ( P = 0.0006), but not TDM alone ( P = 0.16). The sub-study ( n = 53) failed to detect an association between therapeutic serum [UST] at the initial study visit and clinical outcomes at the next visit. Conclusions In consecutive CD patients treated with UST, the addition of TDM into routine clinical practice did not significantly impact clinical decisions and there was no association between short-term clinical outcomes and serum [UST]. Further studies are warranted before clinicians routinely implement UST TDM into clinical practice.
More
Translated text
Key words
Treatment decision making,Treatment optimization,Serum concentrations,Anti-drug antibodies to ustekinumab
AI Read Science
Must-Reading Tree
Example
Generate MRT to find the research sequence of this paper
Chat Paper
Summary is being generated by the instructions you defined