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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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BMC Medicine

ISSN: 1741-7015

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