A prospective cohort study to assess the relevance of Vedolizumab drug level monitoring in IBD patients

Schulze, H; Esters, Philip; Hartmann, Franz; Stein, J.; Zorn, Michael; Christ, C. B.; Dignaß, Axel

doi:10.1055/s-0037-1604798

Cited by 5 publications

(6 citation statements)

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“…The rate of clinical remission (40%) at Week 52 of vedolizumab treatment was comparable to other real‐world data reported in the literature 13–20,27 . Positive exposure–response relationship between serum vedolizumab concentrations and treatment outcomes were observed for UC and CD; however, these associations were more pronounced for UC than CD.…”

Section: Discussionsupporting

confidence: 81%

“…29 However, TDM may be relevant for vedolizumab therapy as has been demonstrated in other studies. [14][15][16][17][18][19][20]30,31 In conclusion, this study provides informative new real-world data demonstrating a positive exposure-response relationship for vedolizumab for UC and CD, whereby lower vedolizumab clearance and higher drug exposure in the early phases of treatment (i.e. induction) are positively associated with better long-term treatment outcomes.…”

Section: Discussionmentioning

confidence: 67%

“…12 Exposure threshold concentrations associated with therapeutic outcomes have not yet been well defined for vedolizumab. Although emerging real-world data further support a role for reactive TDM during vedolizumab therapy, [13][14][15][16][17][18][19][20] additional evidence is needed to support implementation in routine clinical practice and for further evaluation of vedolizumab drug concentrations, along with a range of different therapeutic outcomes. The population pharmacokinetic (PK) model from the phase 3 GEMINI program demonstrated an apparent positive exposure-response relationship for vedolizumab.…”

Section: Introductionmentioning

confidence: 99%

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Real‐world multicentre observational study including population pharmacokinetic modelling to evaluate the exposure–response relationship of vedolizumab in inflammatory bowel disease: ERELATE Study

Casteele

Sandborn

Feagan³

et al. 2022

Aliment Pharmacol Ther

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Summary Background ERELATE was a phase 4, multinational, retrospective, observational study. Aim To evaluate the relationship between intravenous vedolizumab exposure and treatment outcomes over 52 weeks in adults with ulcerative colitis (UC) or Crohn’s disease (CD). Methods Real‐world data from patients with UC or CD treated with intravenous vedolizumab in nine centres in six countries were collected retrospectively. Treatment outcomes were collected at Weeks 14, 26 and 52. An established population pharmacokinetic model (incorporating observed vedolizumab concentrations based on a Bayesian approach) was used to predict individual vedolizumab exposure. Vedolizumab exposure–response relationship was evaluated overall, by indication and based on baseline characteristics. Results The study population (n = 695; UC, n = 304; CD, n = 391) had a median age of 39 years; 47.9% were male and 86.9% had prior tumour necrosis factor antagonist exposure. By Week 14, clinical, endoscopic, deep (clinical plus endoscopic) and biologic remission was achieved by 47.3%, 59.6%, 30.7% and 19.0% of patients respectively. Higher vedolizumab trough concentration early in treatment was consistently associated with clinical remission at later time points. Clinical remission at Week 14 and Week 52 was associated with Week 6 trough concentrations of ≥31.0 and ≥32.0 μg/ml respectively. Importantly, multivariable analysis identified baseline clearance as the only exposure measure predictive of clinical and deep remission at Week 52. Conclusions In this real‐world study, a positive exposure–response relationship was observed for vedolizumab. Vedolizumab concentration during induction may be an important predictor of short‐ and long‐term outcomes, and similarly, vedolizumab baseline clearance may be an important predictor of remission.

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Section: Discussionsupporting

confidence: 81%

Section: Discussionmentioning

confidence: 67%

Section: Introductionmentioning

confidence: 99%

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Real‐world multicentre observational study including population pharmacokinetic modelling to evaluate the exposure–response relationship of vedolizumab in inflammatory bowel disease: ERELATE Study

Casteele

Sandborn

Feagan³

et al. 2022

Aliment Pharmacol Ther

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“…Die ersten klinischen Erfahrungen mit der Talspiegelbestimmung bei Vedolizumab sind derzeit noch sehr begrenzt, deuten aber darauf hin, dass ein Drug Monitoring bei Vedolizumab zur Therapieoptimierung nützlich sein kann. Eine eindeutige Empfehlung zur Anwendung von Drug Monitoring bei Vedolizumab kann derzeit nicht gegeben werden [466][467][468].…”

Section: Drug Monitoring Vedolizumabunclassified

Aktualisierte S3-Leitlinie Colitis ulcerosa

et al. 2019

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“…In another prospective study in patients with IBD, vedolizumab trough levels were also sufficient for complete saturation of a4b7 among responders (41.8 mg/ mL) and nonresponders (39.3 mg/mL). 10 Together, these results suggest that vedolizumab requires additional mechanisms besides peripheral blood a4b7 saturation to achieve clinical efficacy.…”

mentioning

confidence: 89%

PTG-100, an Oral α4β7 Antagonist Peptide: Preclinical Development and Phase 1 and 2a Studies in Ulcerative Colitis

et al. 2021

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A prospective cohort study to assess the relevance of Vedolizumab drug level monitoring in IBD patients

Cited by 5 publications

References 0 publications

Real‐world multicentre observational study including population pharmacokinetic modelling to evaluate the exposure–response relationship of vedolizumab in inflammatory bowel disease: ERELATE Study

Real‐world multicentre observational study including population pharmacokinetic modelling to evaluate the exposure–response relationship of vedolizumab in inflammatory bowel disease: ERELATE Study

Aktualisierte S3-Leitlinie Colitis ulcerosa

PTG-100, an Oral α4β7 Antagonist Peptide: Preclinical Development and Phase 1 and 2a Studies in Ulcerative Colitis

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