Decision Support Tool Identifies Ulcerative Colitis Patients Most Likely to Achieve Remission With Vedolizumab vs Adalimumab

Abstract Background & Aims We have previously validated a clinical decision support tool (CDST) (vedolizumab CDST [VDZ-CDST]) for clinical and endoscopic remission with VDZ in ulcerative colitis (UC). We aim to expand the validation for predicting histoendoscopic mucosal improvement (HEMI) with VDZ vs adalimumab (ADA). Methods In a post hoc analysis of a clinical trial for VDZ vs ADA in moderate to severe UC (VARSITY trial; NCT02497469), comparative accuracy was evaluated for the VDZ-CDST among an external validation cohort of VDZ- and ADA-treated patients for week 52 HEMI (Mayo endoscopic subscore 0-1 and Geboes score <3.2). Comparative effectiveness of VDZ and ADA was assessed after stratifying the cohort by baseline probability of response to VDZ using the VDZ-CDST. Results A total of 419 patients were included. The majority of patients enrolled in the VARSITY trial had a high (61%) or intermediate (29%) baseline predicted probability of response to VDZ. The baseline VDZ-CDST score was significantly more likely to predict week 52 HEMI for VDZ (area under the curve , 0.712; 95% confidence interval, 0.636-0.787) relative to ADA-treated patients (area under the curve, 0.538; 95% confidence interval, 0.377-0.700; P < .001 for AUC comparison). A significant (P < .001) association was observed between the VDZ-CDST and measured VDZ drug exposure over 52 weeks. Superiority of VDZ to ADA was only observed in patients with a high baseline predicted probability of response to VDZ. Conclusions Superiority of VDZ to ADA is dependent on baseline probability of response, and a VDZ-CDST is capable of identifying UC patients most appropriate for VDZ vs ADA.

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Early Intervention With Vedolizumab and Longer-term Surgery Rates in Crohn’s Disease: Post Hoc Analysis of the GEMINI Phase 3 and Long-term Safety Programmes

Journal of Crohn s and Colitis ◽

10.1093/ecco-jcc/jjaa153 ◽

2020 ◽

Author(s):

Parambir S Dulai ◽

Laurent Peyrin-Biroulet ◽

Dirk Demuth ◽

Karen Lasch ◽

Kristen A Hahn ◽

...

Keyword(s):

Crohn’S Disease ◽

Decision Support ◽

Crohn's Disease ◽

Clinical Decision Support ◽

Decision Support Tool ◽

Clinical Decision ◽

Support Tool ◽

Clinical Decision Support Tool ◽

Post Hoc ◽

Probability Of Response

Abstract Background Crohn’s disease [CD] is a chronic inflammatory bowel disease that, with progression, may require surgical intervention. Aim To determine whether vedolizumab treatment of CD earlier in the disease course [≤2 or ≤5 years of disease duration] influences risk of CD-related surgery after accounting for probability of response. Methods Post hoc analyses of data from CD patients treated with vedolizumab in the GEMINI 2, GEMINI 3, and GEMINI LTS trials [N = 1253] evaluated CD-related surgery [bowel resection or colectomy] with stratification by probability of response to vedolizumab [low/intermediate or high]. Analyses used a previously validated clinical decision support tool and both logistic regression and Cox proportional hazard analyses. Results In total, 113 [9.0%] vedolizumab-treated patients required CD-related surgery. Surgical rates were 6.1% and 9.8% for the high and low/intermediate probability of response groups, respectively. Risk of surgery was lower for patients with a high probability of response versus those with a low/intermediate probability of response (hazard ratio [HR] 0.50, 95% confidence interval [CI] 0.29 to 0.85). For patients with a low/intermediate probability of vedolizumab response, there was a consistent trend for association between earlier treatment [≤2 or ≤5 years since diagnosis] and a lower risk of surgery relative to later treatment (≤2 years versus >2 years: odds ratio [OR] 0.77, 95% CI 0.38 to 1.58; ≤5 years versus >5 years: OR 0.61, 95% CI 0.37 to 1.00]. Conclusions Earlier intervention with vedolizumab may be associated with lower rates of surgery. Use of the clinical decision support tool may help identify patients most likely to benefit from earlier intervention with vedolizumab.

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Mild-to-Moderate Ulcerative Colitis (UC) Clinical Decision Support Tool

Gastroenterology ◽

10.1053/j.gastro.2019.01.038 ◽

2019 ◽

Vol 156 (3) ◽

pp. 765

Keyword(s):

Ulcerative Colitis ◽

Decision Support ◽

Clinical Decision Support ◽

Decision Support Tool ◽

Clinical Decision ◽

Support Tool ◽

Clinical Decision Support Tool

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Use of an electronic decision support tool to reduce polypharmacy in elderly people with chronic diseases: cluster randomised controlled trial

BMJ ◽

10.1136/bmj.m1822 ◽

2020 ◽

pp. m1822 ◽

Cited By ~ 9

Author(s):

Anja Rieckert ◽

David Reeves ◽

Attila Altiner ◽

Eva Drewelow ◽

Aneez Esmail ◽

...

Keyword(s):

Decision Support ◽

Confidence Interval ◽

Hospital Admission ◽

Elderly People ◽

Intervention Group ◽

Decision Support Tool ◽

Control Group ◽

Electronic Decision Support ◽

Support Tool ◽

Drug Review

Abstract Objective To evaluate the effects of a computerised decision support tool for comprehensive drug review in elderly people with polypharmacy. Design Pragmatic, multicentre, cluster randomised controlled trial. Setting 359 general practices in Austria, Germany, Italy, and the United Kingdom. Participants 3904 adults aged 75 years and older using eight or more drugs on a regular basis, recruited by their general practitioner. Intervention A newly developed electronic decision support tool comprising a comprehensive drug review to support general practitioners in deprescribing potentially inappropriate and non-evidence based drugs. Doctors were randomly allocated to either the electronic decision support tool or to provide treatment as usual. Main outcome measures The primary outcome was the composite of unplanned hospital admission or death by 24 months. The key secondary outcome was reduction in the number of drugs. Results 3904 adults were enrolled between January and October 2015. 181 practices and 1953 participants were assigned to electronic decision support (intervention group) and 178 practices and 1951 participants to treatment as usual (control group). The primary outcome (composite of unplanned hospital admission or death by 24 months) occurred in 871 (44.6%) participants in the intervention group and 944 (48.4%) in the control group. In an intention-to-treat analysis the odds ratio of the composite outcome was 0.88 (95% confidence interval 0.73 to 1.07; P=0.19, 997 of 1953 v 1055 of 1951). In an analysis restricted to participants attending practice according to protocol, a difference was found favouring the intervention (odds ratio 0.82, 95% confidence interval 0.68 to 0.98; 774 of 1682 v 873 of 1712, P=0.03). By 24 months the number of prescribed drugs had decreased in the intervention group compared with control group (uncontrolled mean change −0.42 v 0.06: adjusted mean difference −0.45, 95% confidence interval −0.63 to −0.26; P<0.001). Conclusions In intention-to-treat analysis, a computerised decision support tool for comprehensive drug review of elderly people with polypharmacy showed no conclusive effects on the composite of unplanned hospital admission or death by 24 months. Nonetheless, a reduction in drugs was achieved without detriment to patient outcomes. Trial registration Current Controlled Trials ISRCTN10137559 .

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