Effectiveness of vedolizumab dose intensification to achieve inflammatory bowel disease control in cases of suboptimal response

Mark A. Samaan; Siddharth Birdi; Maria Sierra Morales; Sailish Honap; Aravind Gokul Tamilarasan; Georgina Cunningham; Ioannis Koumoutsos; Shuvra Ray; Joel Mawdsley; Simon H.C. Anderson; Jeremy Sanderson; Peter M. Irving

doi:10.1136/flgastro-2019-101259

Effectiveness of vedolizumab dose intensification to achieve inflammatory bowel disease control in cases of suboptimal response

Mark A. Samaan^*, Siddharth Birdi, Maria Sierra Morales, Sailish Honap, Aravind Gokul Tamilarasan, Georgina Cunningham, Ioannis Koumoutsos, Shuvra Ray, Joel Mawdsley, Simon H.C. Anderson, Jeremy Sanderson, Peter M. Irving

^*Corresponding author for this work

King's College London

Research output: Contribution to journal › Article › peer-review

12 Citations (Scopus)

Abstract

Background Despite the proven efficacy of vedolizumab (VDZ) for ulcerative colitis (UC) and Crohn's disease (CD), suboptimal response is commonly encountered. However, data regarding the effectiveness of dose intensification (by interval shortening) to achieve response are limited. Objectives We evaluated the effectiveness of dose intensification at achieving response in patients with a previously suboptimal response to VDZ. Additionally, we aimed to identify predictors of response to this strategy. Methods We performed a retrospective cohort study of patients who underwent VDZ dose intensification for suboptimal response. Clinical disease activity was evaluated at the point of dose intensification (baseline) and at weeks 12 and 24. Response was defined as Harvey-Bradshaw Index (HBI) or Simple Clinical Colitis Activity Index (SCCAI) reduction of ≥3, and remission as HBI <5 or SCCAI <3. Results A total of 36 patients received dose intensification to 4-weekly infusions: 18 CD, 14 UC and 4 inflammatory bowel disease-unclassified (analysed in the UC group). Median SCCAI scores fell from 6 (range 0-11) at baseline to 4 (0-6, p=0.008) at week 24, while HBI scores did not change significantly (4 (0-27) and 3 (0-8), p=0.092). Overall median C reactive protein (CRP) fell from 6 mg/L (1-23) to 2 mg/L (1-17, p=0.011). Of 20 patients with clinically active disease at baseline, 10 (50%) responded, of whom 4 (20%) achieved remission at week 24. Univariate analysis demonstrated low baseline CRP (p=0.045) and response at week 12 (0.020) were associated with week 24 response. Conclusions Our findings demonstrate VDZ dose intensification to be effective at achieving clinical response in half of patients. Low baseline CRP and response at week 12 are potential predictors of week 24 response.

Original language	English
Pages (from-to)	188-193
Number of pages	6
Journal	Frontline Gastroenterology
Volume	11
Issue number	3
DOIs	https://doi.org/10.1136/flgastro-2019-101259
Publication status	Published - 1 May 2020

Keywords

Crohn's disease
dose intensification
entyvio
inflammatory bowel disease
ulcerative colitis
vedolizumab

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10.1136/flgastro-2019-101259

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Samaan, M. A., Birdi, S., Morales, M. S., Honap, S., Tamilarasan, A. G., Cunningham, G., Koumoutsos, I., Ray, S., Mawdsley, J., Anderson, S. H. C., Sanderson, J., & Irving, P. M. (2020). Effectiveness of vedolizumab dose intensification to achieve inflammatory bowel disease control in cases of suboptimal response. Frontline Gastroenterology, 11(3), 188-193. https://doi.org/10.1136/flgastro-2019-101259

@article{238281420fa64235b1971f8c85b4c81d,

title = "Effectiveness of vedolizumab dose intensification to achieve inflammatory bowel disease control in cases of suboptimal response",

abstract = "Background Despite the proven efficacy of vedolizumab (VDZ) for ulcerative colitis (UC) and Crohn's disease (CD), suboptimal response is commonly encountered. However, data regarding the effectiveness of dose intensification (by interval shortening) to achieve response are limited. Objectives We evaluated the effectiveness of dose intensification at achieving response in patients with a previously suboptimal response to VDZ. Additionally, we aimed to identify predictors of response to this strategy. Methods We performed a retrospective cohort study of patients who underwent VDZ dose intensification for suboptimal response. Clinical disease activity was evaluated at the point of dose intensification (baseline) and at weeks 12 and 24. Response was defined as Harvey-Bradshaw Index (HBI) or Simple Clinical Colitis Activity Index (SCCAI) reduction of ≥3, and remission as HBI <5 or SCCAI <3. Results A total of 36 patients received dose intensification to 4-weekly infusions: 18 CD, 14 UC and 4 inflammatory bowel disease-unclassified (analysed in the UC group). Median SCCAI scores fell from 6 (range 0-11) at baseline to 4 (0-6, p=0.008) at week 24, while HBI scores did not change significantly (4 (0-27) and 3 (0-8), p=0.092). Overall median C reactive protein (CRP) fell from 6 mg/L (1-23) to 2 mg/L (1-17, p=0.011). Of 20 patients with clinically active disease at baseline, 10 (50%) responded, of whom 4 (20%) achieved remission at week 24. Univariate analysis demonstrated low baseline CRP (p=0.045) and response at week 12 (0.020) were associated with week 24 response. Conclusions Our findings demonstrate VDZ dose intensification to be effective at achieving clinical response in half of patients. Low baseline CRP and response at week 12 are potential predictors of week 24 response.",

keywords = "Crohn's disease, dose intensification, entyvio, inflammatory bowel disease, ulcerative colitis, vedolizumab",

author = "Samaan, {Mark A.} and Siddharth Birdi and Morales, {Maria Sierra} and Sailish Honap and Tamilarasan, {Aravind Gokul} and Georgina Cunningham and Ioannis Koumoutsos and Shuvra Ray and Joel Mawdsley and Anderson, {Simon H.C.} and Jeremy Sanderson and Irving, {Peter M.}",

year = "2020",

month = may,

day = "1",

doi = "10.1136/flgastro-2019-101259",

language = "English",

volume = "11",

pages = "188--193",

journal = "Frontline Gastroenterology",

issn = "2041-4137",

publisher = "BMJ Publishing Group",

number = "3",

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Samaan, MA, Birdi, S, Morales, MS, Honap, S, Tamilarasan, AG, Cunningham, G, Koumoutsos, I, Ray, S, Mawdsley, J, Anderson, SHC, Sanderson, J & Irving, PM 2020, 'Effectiveness of vedolizumab dose intensification to achieve inflammatory bowel disease control in cases of suboptimal response', Frontline Gastroenterology, vol. 11, no. 3, pp. 188-193. https://doi.org/10.1136/flgastro-2019-101259

TY - JOUR

T1 - Effectiveness of vedolizumab dose intensification to achieve inflammatory bowel disease control in cases of suboptimal response

AU - Samaan, Mark A.

AU - Birdi, Siddharth

AU - Morales, Maria Sierra

AU - Honap, Sailish

AU - Tamilarasan, Aravind Gokul

AU - Cunningham, Georgina

AU - Koumoutsos, Ioannis

AU - Ray, Shuvra

AU - Mawdsley, Joel

AU - Anderson, Simon H.C.

AU - Sanderson, Jeremy

AU - Irving, Peter M.

PY - 2020/5/1

Y1 - 2020/5/1

N2 - Background Despite the proven efficacy of vedolizumab (VDZ) for ulcerative colitis (UC) and Crohn's disease (CD), suboptimal response is commonly encountered. However, data regarding the effectiveness of dose intensification (by interval shortening) to achieve response are limited. Objectives We evaluated the effectiveness of dose intensification at achieving response in patients with a previously suboptimal response to VDZ. Additionally, we aimed to identify predictors of response to this strategy. Methods We performed a retrospective cohort study of patients who underwent VDZ dose intensification for suboptimal response. Clinical disease activity was evaluated at the point of dose intensification (baseline) and at weeks 12 and 24. Response was defined as Harvey-Bradshaw Index (HBI) or Simple Clinical Colitis Activity Index (SCCAI) reduction of ≥3, and remission as HBI <5 or SCCAI <3. Results A total of 36 patients received dose intensification to 4-weekly infusions: 18 CD, 14 UC and 4 inflammatory bowel disease-unclassified (analysed in the UC group). Median SCCAI scores fell from 6 (range 0-11) at baseline to 4 (0-6, p=0.008) at week 24, while HBI scores did not change significantly (4 (0-27) and 3 (0-8), p=0.092). Overall median C reactive protein (CRP) fell from 6 mg/L (1-23) to 2 mg/L (1-17, p=0.011). Of 20 patients with clinically active disease at baseline, 10 (50%) responded, of whom 4 (20%) achieved remission at week 24. Univariate analysis demonstrated low baseline CRP (p=0.045) and response at week 12 (0.020) were associated with week 24 response. Conclusions Our findings demonstrate VDZ dose intensification to be effective at achieving clinical response in half of patients. Low baseline CRP and response at week 12 are potential predictors of week 24 response.

AB - Background Despite the proven efficacy of vedolizumab (VDZ) for ulcerative colitis (UC) and Crohn's disease (CD), suboptimal response is commonly encountered. However, data regarding the effectiveness of dose intensification (by interval shortening) to achieve response are limited. Objectives We evaluated the effectiveness of dose intensification at achieving response in patients with a previously suboptimal response to VDZ. Additionally, we aimed to identify predictors of response to this strategy. Methods We performed a retrospective cohort study of patients who underwent VDZ dose intensification for suboptimal response. Clinical disease activity was evaluated at the point of dose intensification (baseline) and at weeks 12 and 24. Response was defined as Harvey-Bradshaw Index (HBI) or Simple Clinical Colitis Activity Index (SCCAI) reduction of ≥3, and remission as HBI <5 or SCCAI <3. Results A total of 36 patients received dose intensification to 4-weekly infusions: 18 CD, 14 UC and 4 inflammatory bowel disease-unclassified (analysed in the UC group). Median SCCAI scores fell from 6 (range 0-11) at baseline to 4 (0-6, p=0.008) at week 24, while HBI scores did not change significantly (4 (0-27) and 3 (0-8), p=0.092). Overall median C reactive protein (CRP) fell from 6 mg/L (1-23) to 2 mg/L (1-17, p=0.011). Of 20 patients with clinically active disease at baseline, 10 (50%) responded, of whom 4 (20%) achieved remission at week 24. Univariate analysis demonstrated low baseline CRP (p=0.045) and response at week 12 (0.020) were associated with week 24 response. Conclusions Our findings demonstrate VDZ dose intensification to be effective at achieving clinical response in half of patients. Low baseline CRP and response at week 12 are potential predictors of week 24 response.

KW - Crohn's disease

KW - dose intensification

KW - entyvio

KW - inflammatory bowel disease

KW - ulcerative colitis

KW - vedolizumab

UR - http://www.scopus.com/inward/record.url?scp=85069193079&partnerID=8YFLogxK

U2 - 10.1136/flgastro-2019-101259

DO - 10.1136/flgastro-2019-101259

M3 - Article

AN - SCOPUS:85069193079

SN - 2041-4137

VL - 11

SP - 188

EP - 193

JO - Frontline Gastroenterology

JF - Frontline Gastroenterology

IS - 3

ER -

Effectiveness of vedolizumab dose intensification to achieve inflammatory bowel disease control in cases of suboptimal response

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