Entyvio lengthen dose-interval study: lengthening vedolizumab dose interval and the risk of clinical relapse in inflammatory bowel disease

Chan, Webber; Lynch, Nicole A.; Bampton, Peter A.; Chang, Jeff; Chung, Alvin; Florin, Timothy H.; Hetzel, David J.; Jakobovits, Simon; Moore, Gregory Thomas Charles; Pavli, Paul; Radford‐Smith, Graham; Thin, Lena; Baraty, Brandon; Haifer, Craig; Yau, Yunk; Leong, Rupert W.

doi:10.1097/meg.0000000000001150

Cited by 10 publications

(16 citation statements)

References 14 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…Of the 48 studies reporting dose escalation, 20 reported dose increases only, 14 reported interval shortening, and 14 reported dose escalation via both methods ( Supplementary Table 4 ). 21–29 , 31 , 32 , 34–38 , 40–42 , 45–52 , 54 , 55 , 57–69 , 71 , 72 , 74–76 One study did not describe the method of dose optimization. 24 Follow-up times varied from ≤12 months in 11 studies to >12-≤24 months in 10 studies and >24 months in 8 studies; follow-up times were not reported for the remaining 19 studies.…”

Section: Resultsmentioning

confidence: 99%

“…There were 9 reports of dose escalation done to address LOR, 31 , 44 , 46 , 63 , 66–68 , 75 , 76 whereas the remaining 39 dose escalations were done for any reason ( Figure 2 ). 22–29 , 32 , 34 , 35 , 37 , 38 , 40–42 , 45 , 47–52 , 55 , 57–62 , 64 , 65 , 69 , 71 , 72 , 74 The average rate of escalation by dose increase varied greatly, ranging from 80% to 340% relative to the starting dose ( Supplementary Table 5 ). 26 , 29 , 31 , 35 , 36 , 38 , 40 , 46 , 49 , 52 , 57 , 59 , 61–63 , 65–69 , 75 In studies with follow-up times of ≤12 months, the rate of dose escalation was 11.5–44%, whereas in studies with follow-up times of >12-≤24 months and >24 months, the rate of dose escalation was 8.4–73.5% and 4.9–54.0%, respectively ( Supplementary Table 4 ).…”

Section: Resultsmentioning

confidence: 99%

See 1 more Smart Citation

Systematic Literature Review of Real-World Evidence on Dose Escalation and Treatment Switching in Ulcerative Colitis

Singh¹,

Wilson²,

Tencer³

et al. 2023

CEOR

View full text Add to dashboard Cite

Background Currently approved biologic therapies for moderate-to-severe ulcerative colitis have well-established efficacy. However, many patients fail to respond or lose response, leading to dose escalation or treatment switching. Objective We sought to identify real-world evidence on dose escalation and treatment switching and associated clinical and economic outcomes among adults with ulcerative colitis treated with infliximab, adalimumab, golimumab, vedolizumab, ustekinumab, or tofacitinib. Methods We conducted a systematic search of Embase, MEDLINE (up to 26 August 2020), and conference proceedings (2017−2020) for studies in adults with ulcerative colitis to assess clinical response and remission, colectomy, adverse events, and economic outcomes related to dose escalation and treatment switching. Results In 56 studies, dose escalation and treatment switching involving infliximab and/or adalimumab were most frequently investigated. Rates of clinical response after dose escalation were 20–95% (1.8–36 months), clinical remission rates were 10–94% (1.8–36 months), colectomy rates were 0–33% (12–38 months), and adverse event rates were 0–18%. Treatment switching rates in 21 studies were 4–70% over 3–62 months, with switch due to loss of response rates of 4–35% over 12–62 months (7 studies). Up to 35% of patients underwent colectomy 12−120 weeks after switching, and 13–38% experienced adverse events. Data relating to economic outcomes were limited to tumor necrosis factor inhibitors, but demonstrated increased direct costs associated with both dose escalation and treatment switching. Conclusion Dose escalation and treatment switching are common with existing therapies. However, clinical response and remission rates vary, and a proportion of patients fail to achieve optimal clinical and economic outcomes. This highlights the need for more efficacious and durable treatments for patients with moderate-to-severe ulcerative colitis.

show abstract

Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

Systematic Literature Review of Real-World Evidence on Dose Escalation and Treatment Switching in Ulcerative Colitis

Singh¹,

Wilson²,

Tencer³

et al. 2023

CEOR

View full text Add to dashboard Cite

show abstract

“…A 15% relapse rate was observed in one study that switched patients from every-4-week to every-8-week VDZ (and appears similar between UC and CD). Upon dose intensification back to every 4 weeks, 80% re-entered remission 35 . This suggests that, in patients with CD, increasing dose frequency of VDZ to every 4 weeks could lead to an improvement.…”

Section: Newer Mechanisms: Tips and Tricksmentioning

confidence: 99%

“…Unlike for anti-TNF agents, it is not yet a well-established tool used by clinicians as a guide for dose adjustment. Despite studies that have demonstrated that there may be potential value of TDM, the lack of unequivocal supporting data means that most changes in dose frequency are currently made empirically 35 . To help guide response to induction and maintenance dosing, we recommend checking objective markers of disease activity at weeks 0 and 14.…”

Section: Newer Mechanisms: Tips and Tricksmentioning

confidence: 99%

“…Subsequent literature suggests that week 6 drug level monitoring is a relevant predictor of remission or of the need for subsequent dose intensification 41– 43 . One study reported that a week 6 level of over 20 µg/mL may be associated with improved clinical outcomes 35 . Another observed an association between a week 6 level of over 18 µg/mL and increased rates of mucosal healing 43 .…”

Section: Newer Mechanisms: Tips and Tricksmentioning

confidence: 99%

See 1 more Smart Citation

Biologic therapies for Crohn’s disease: optimising the old and maximising the new

et al. 2019

View full text Add to dashboard Cite

The era of biologic agents for the treatment of Crohn’s disease has brought about significant benefits for patients, and since the introduction of infliximab at the turn of the century, the entire field has moved on rapidly. Clinicians now have multiple agents at their disposal and a choice between several different anti-inflammatory mechanisms of action. This has allowed unprecedented improvements not only in symptoms and quality of life for patients previously refractory to conventional treatments but also for demonstrated healing of the intestinal mucosa and resolution of perianal fistulation. However, despite the undisputed efficacy of these agents, there remains a significant proportion of patients who fail to gain a meaningful benefit. Through years of studying infliximab and its counterpart anti-tumour necrosis factor (anti-TNF) agent, adalimumab, we now understand that strategies such as combining use with a conventional immunomodulator or measuring serum levels can help to optimise outcomes and reduce the proportion of patients for whom treatment fails. Work is ongoing to understand whether these principles apply to newer biologics such as vedolizumab and ustekinumab. In addition, novel approaches are being investigated in an attempt to maximise the benefit that these agents could offer. In this article, we summarise these new understandings and consider ways in which they could be integrated into clinical practice for the benefit of patients.

show abstract

Vedolizumab Dose Escalation Improves Therapeutic Response in a Subset of Patients with Ulcerative Colitis

et al. 2020

View full text Add to dashboard Cite

Entyvio lengthen dose-interval study: lengthening vedolizumab dose interval and the risk of clinical relapse in inflammatory bowel disease

Abstract: The risk of patients relapsing when switching from 4 to 8-weekly VDZ ∼15% and is similar between CD and UC. Dose-interval decrease recaptures 80% of patients who relapsed. Therapeutic drug monitoring of VDZ may be of clinical relevance.

Cited by 10 publications

References 14 publications

Systematic Literature Review of Real-World Evidence on Dose Escalation and Treatment Switching in Ulcerative Colitis

Systematic Literature Review of Real-World Evidence on Dose Escalation and Treatment Switching in Ulcerative Colitis

Biologic therapies for Crohn’s disease: optimising the old and maximising the new

Vedolizumab Dose Escalation Improves Therapeutic Response in a Subset of Patients with Ulcerative Colitis

Contact Info

Product

Resources

About