Specificity of clinical decision support tools for vedolizumab and ustekinumab in biologically naïve patients with Crohn’s disease

Abstract

Background and aims

Clinical decision support tools (CDST) were developed to predict drug response to various biological treatments for Crohn’s disease (CD). This study investigated whether CDSTs for vedolizumab (V-CDST) and ustekinumab (U-CDST) can be used as prognostic or drug-specific markers to predict response.

Methods

A hypothetical scenario involving 872 patients with CD who were exposed to the first biological therapy at Samsung Medical Center between 1995 and 2020 is presented. V-CDST & U-CDST were calculated based on clinical and laboratory data immediately before the first biologic was initiated. The Cumulative Link Mixed Model (CLMM) test, weighted Kappa and plot, and Spearman’s correlation was used to determine the degree of agreement and difference between the two tools.

Results

25% of all patients diagnosed with biologically naïve CD were categorized into different probability groups using V-CDST and U-CDST. The difference between the two tools was significantly based on a two-sample paired ordinal test with Cumulative Link Mixed Model (CLMM) (p-value < .001). Concordance between the two tools with a total of 654 subjects (75% of all patients) showed a similar probability (weighted Kappa: 0.47, 95% CI: 0.41–0.52).

Conclusions

V-CDST and U-CDST are useful in selecting vedolizumab or ustekinumab in 25% of biologically naïve CD patients in our hypothetical scenario.

Keywords:

• Crohn’s disease
• CDST
• V-CDST
• U-CDST

Authorship

Guarantor of the article: KYH

Author contributions

Study concept and design: KYH; Data acquisition: KJE; Data analysis, and drafting of manuscript: KJE, WHJ; Critical revision for intellectual content: KER, HSN, CDK; All authors read and approved the final manuscript.

Disclosure statement

All Authors declare that they have no conflicts of interest regarding the content of this manuscript.

Data availability statement

Supporting information is available in the additional files and further supporting data is available from the authors on request