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Table 1 Exposure–efficacy relationship of vedolizumab in inflammatory bowel disease

From: Vedolizumab trough level monitoring in inflammatory bowel disease: a state-of-the-art overview

Reference Design Number of patients Main outcome parameter Key findings    Other findings
Clinical trials
 Rosario et al. (2017) [9] Clinical trial (post-hoc analysis) 681 (UC); 850 (CD) Vedolizumab TL and clinical remission statusa at week 6 Median (IQR) TL at week 6: clinical remission (UC) 34.7 (31.7–36.6) P-value: not stated TL at week 6 < 17 (UC) and < 16 (CD): clinical remission rates similar to placebo
    Median (IQR) TL at week 6: no clinical remission (UC) 23.7 (22.0–24.8)   
    Median (IQR) TL at week 6: clinical remission (CD) 26.8 (24.9–30.1) P-value: not stated  
    Median (IQR) TL at week 6: no clinical remission (CD) 23.5 (22.4–24.8)   
 Osterman et al. (2019) [10] Clinical trial (post-hoc analysis); propensity-score-based case-matching analysis 693 (UC) Target vedolizumab TL for clinical response/remissionb, adjusted for confounding factors on drug clearance Target TL at different timepoints for clinical response/remission    Week 6 was the earliest time point at which TL was consistently associated with clinical response and remission at week 14 and week 52
    Week 6 > 37.1   
    Week 14 > 18.4   
    Maintenance > 12.7   
Real-world cohorts
 Williet et al. (2017) [11] Prospective, observational; multicentric 16 (UC); 31 (CD) Association between vedolizumab TL at week 0–6 and need for additional dosing in first 6 months Cut-off TL associated with the need for additional dosing in first 6 months    
    Week 2 < 24.5 AUROC 0.62  
    Week 6 < 18.5 AUROC 0.72  
 Al-Bawardy et al. (2018) [12] Retrospective, cross-sectional; single-centre 53 (UC); 106 (CD); 12 (IBDU) Vedolizumab TL and mucosal healingc Median (IQR) TL and mucosal healing 13.7 (10–32.9) P = 0.64  
    Median (IQR) TL and no mucosal healing 16.1 (7.7–27.6)   
 Dreesen et al. (2018) [13] Retrospective, observational; single-centre 66 (UC); 113 (CD) Vedolizumab TL and clinical/biological/endoscopic effectiveness endpointsd at week 14 (UC) and week 22 (CD) Cut-off TL associated with effectiveness at week 14/22 (UC/CD)    
    Week 2 > 30 P < 0.05  
    Week 6 > 24 P < 0.05  
    Week 14 > 14 P < 0.05  
 Yacoub et al. (2018) [14] Prospective, observational; multicentric 43 (UC); 39 (CD) Vedolizumab TL during induction (weeks 2, 6, 14) and mucosal healinge within 1 year Median (IQR) TL and mucosal healing within 1 year    TL at week 6 > 18 was the only independent variable associated with mucosal healing within 1 year (AUROC: 0.735)
    Week 2 27 (23.6–33.8) P = 0.845  
    Week 6 26.8 (21.4–40.4) P = 0.035  
    Week 14 16 (8–21) P = 0.241  
    Median (IQR) TL and no mucosal healing within 1 year    
    Week 2 27.8 (18.1–34.5) P = 0.845  
     Week 6 15.1 (13.4–23.5) P = 0.035  
     Week 14 6.3 (4.5–15) P = 0.241  
 Ungaro et al. (2019) [15] Prospective, cross-sectional; multicentric 116 (UC); 142 (CD) Vedolizumab TL and corticosteroid-free clinical and biochemical remission during maintenance therapyf Median (IQR) TL and steroid-free clinical and biochemical remission 12.7 (8.4–19.4) P = 0.002 Patients with TL > 11.5 were 2.4 times more likely to be in corticosteroid-free clinical and biochemical remission
    Median (IQR) TL and no steroid-free clinical and biochemical remission 10.1 (5.9–15.2)   
 Pouillon et al. (2019) [16] Retrospective, cross-sectional; single-centre 31g (UC) Vedolizumab TL and histological healingh Median (IQR) TL and histological healing 31.5 (25–49.1) P = 0.02 TL > 25 was most optimal to predict histological healing (AUROC: 0.62)
Median (IQR) TL and no histological healing 15 (9–26.6)
 Yarur et al. (2019) [17] Prospective, observational; single-centre 30 (UC); 25 (CD) Vedolizumab TL during induction (weeks 2, 6, 14) and steroid-free endoscopic remission at week 52i Median (IQR) TL and steroid-free endoscopic remission at week 52    
Week 2 24.8 (23–28) P = 0.005
Week 6 25 (17–28) P = 0.016
Week 14 11 (7–17) P = 0.42
Median (IQR) TL and no steroid-free endoscopic remission at week 52   
Week 2 20 (18–25) P = 0.005
Week 6 17.3 (10–24) P = 0.016
Week 14 8 (6–14) P = 0.42
  1. AUROC area under the receiver operating curve, CD Crohn’s disease, IBDu indeterminate inflammatory bowel disease, IQR interquartile range, TL trough level (expressed in μg/mL), UC ulcerative colitis
  2. aComplete Mayo score of ≤2 points AND no individual subscore > 1 point (UC) OR CD activity score of ≤150 points
  3. bClinical response: reduction in complete or partial Mayo score of ≥3 points and ≥ 30% from baseline, AND a decrease of ≥1 point on the rectal bleeding subscore, OR an absolute rectal bleeding subscore ≤1; clinical remission: complete Mayo score of ≤2 points, AND no individual subscore > 1 point (UC)
  4. cAbsence of ulcers (CD) OR Mayo endoscopic subscore ≤1 (UC)
  5. dClinical effectiveness: physician global assessment; biological effectiveness: C-reactive protein level < 5 mg/L; endoscopic effectiveness: absence of ulcers (CD) OR Mayo endoscopic subscore ≤1 (UC)
  6. eAbsence of significant intestinal inflammation on magnetic resonance imaging, AND/OR absence of ulcers (CD), OR Mayo endoscopic subscore ≤1 (UC)
  7. fHarvey Bradshaw Index < 5 (CD), OR partial Mayo score < 2 (UC), AND C-reactive protein level < 5 mg/L, AND no oral corticosteroid use in prior four weeks
  8. gThirty-five histological samples from 31 patients
  9. hNancy histological index ≤1
  10. iSimple endoscopic score < 2 (CD), OR Mayo endoscopic subscore ≤1 (UC) while off steroids
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