Vedolizumab: early experience and medium-term outcomes from two UK tertiary IBD centres

Mark A Samaan; Polychronis Pavlidis; Emma Johnston; Ben Warner; Jonathan Digby-Bell; Ioannis Koumoutsos; Steven Fong; Rimma Goldberg; Kamal Patel; Shraddha Gulati; Lucy Medcalf; Marlene Sastrillo; Cordella Brown-Clarke; Johanna Bidewell-Sullivan; Katrina Forsyth; Emma Lee; Anna Stanton; Julie Duncan; Guy Chung-Faye; Patrick Dubois; Nick Powell; Simon Anderson; Jeremy Sanderson; Bu'Hussain Hayee; Peter M Irving

doi:10.1136/flgastro-2016-100720

Vedolizumab: early experience and medium-term outcomes from two UK tertiary IBD centres

Mark A Samaan, Polychronis Pavlidis, Emma Johnston, Ben Warner, Jonathan Digby-Bell, Ioannis Koumoutsos, Steven Fong, Rimma Goldberg, Kamal Patel, Shraddha Gulati, Lucy Medcalf, Marlene Sastrillo, Cordella Brown-Clarke, Johanna Bidewell-Sullivan, Katrina Forsyth, Emma Lee, Anna Stanton, Julie Duncan, Guy Chung-Faye, Patrick DuboisNick Powell, Simon Anderson, Jeremy Sanderson, Bu'Hussain Hayee, Peter M Irving

King's College London

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

29 Citations (Scopus)

Abstract

OBJECTIVE: To gain an understanding of the efficacy of vedolizumab in a 'real-world' setting.

DESIGN: Retrospective cohort study using prospectively maintained clinical records.

SETTING: Two UK tertiary inflammatory bowel disease (IBD) centres.

PATIENTS: Patients with IBD commenced on vedolizumab at Guy's & St Thomas' and King's College Hospitals during November 2014-November 2015.

INTERVENTION: Vedolizumab, a monoclonal antibody to α-4 β-7 integrins that selectively inhibit leucocyte migration into the gut.

MAIN OUTCOME MEASURES: Clinical disease activity was assessed at baseline, weeks 14 and 30 using Harvey-Bradshaw Index (HBI) for Crohn's disease (CD) and Simple Clinical Colitis Activity Index (SCCAI) for ulcerative colitis (UC). Response was defined as HBI or SCCAI reduction ≥3. Remission was defined as HBI <5 or SCCAI <3. Continuous data are summarised as medians, followed by range.

RESULTS: Fifty patients were included: 27 CD, 20 UC and 3 IBD-U (included in the UC group for analysis). At baseline visit, the median HBI was 8 (1-16) and SCCAI was 6 (0-15). At week 14, these values had fallen to 5 (0-15) (p=0.117) and 4 (0-10) (p=0.005), respectively. Additionally, week 30 data were available for 19 patients (9 CD, 10 UC). The clinical disease activity scores at that point were HBI 2 (0-7) (p=0.039) and SCCAI 2 (0-10) (p=0.023). At baseline, 37 (74%) of the 50 patients had clinically active disease. Of the patients with active disease, 22 (59%) responded and 14 (38%) achieved remission at week 14.

CONCLUSIONS: Our early experience with vedolizumab demonstrates a clear benefit in terms of disease control as well as a steroid-sparing effect in a cohort, which included patients with complex and previously refractory disease.

Original language	English
Pages (from-to)	196-202
Number of pages	7
Journal	Frontline Gastroenterology
Volume	8
Issue number	3
DOIs	https://doi.org/10.1136/flgastro-2016-100720
Publication status	Published - Jul 2017

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Samaan, M. A., Pavlidis, P., Johnston, E., Warner, B., Digby-Bell, J., Koumoutsos, I., Fong, S., Goldberg, R., Patel, K., Gulati, S., Medcalf, L., Sastrillo, M., Brown-Clarke, C., Bidewell-Sullivan, J., Forsyth, K., Lee, E., Stanton, A., Duncan, J., Chung-Faye, G., ... Irving, P. M. (2017). Vedolizumab: early experience and medium-term outcomes from two UK tertiary IBD centres. Frontline Gastroenterology, 8(3), 196-202. https://doi.org/10.1136/flgastro-2016-100720

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title = "Vedolizumab: early experience and medium-term outcomes from two UK tertiary IBD centres",

abstract = "OBJECTIVE: To gain an understanding of the efficacy of vedolizumab in a 'real-world' setting.DESIGN: Retrospective cohort study using prospectively maintained clinical records.SETTING: Two UK tertiary inflammatory bowel disease (IBD) centres.PATIENTS: Patients with IBD commenced on vedolizumab at Guy's & St Thomas' and King's College Hospitals during November 2014-November 2015.INTERVENTION: Vedolizumab, a monoclonal antibody to α-4 β-7 integrins that selectively inhibit leucocyte migration into the gut.MAIN OUTCOME MEASURES: Clinical disease activity was assessed at baseline, weeks 14 and 30 using Harvey-Bradshaw Index (HBI) for Crohn's disease (CD) and Simple Clinical Colitis Activity Index (SCCAI) for ulcerative colitis (UC). Response was defined as HBI or SCCAI reduction ≥3. Remission was defined as HBI <5 or SCCAI <3. Continuous data are summarised as medians, followed by range.RESULTS: Fifty patients were included: 27 CD, 20 UC and 3 IBD-U (included in the UC group for analysis). At baseline visit, the median HBI was 8 (1-16) and SCCAI was 6 (0-15). At week 14, these values had fallen to 5 (0-15) (p=0.117) and 4 (0-10) (p=0.005), respectively. Additionally, week 30 data were available for 19 patients (9 CD, 10 UC). The clinical disease activity scores at that point were HBI 2 (0-7) (p=0.039) and SCCAI 2 (0-10) (p=0.023). At baseline, 37 (74%) of the 50 patients had clinically active disease. Of the patients with active disease, 22 (59%) responded and 14 (38%) achieved remission at week 14.CONCLUSIONS: Our early experience with vedolizumab demonstrates a clear benefit in terms of disease control as well as a steroid-sparing effect in a cohort, which included patients with complex and previously refractory disease.",

author = "Samaan, {Mark A} and Polychronis Pavlidis and Emma Johnston and Ben Warner and Jonathan Digby-Bell and Ioannis Koumoutsos and Steven Fong and Rimma Goldberg and Kamal Patel and Shraddha Gulati and Lucy Medcalf and Marlene Sastrillo and Cordella Brown-Clarke and Johanna Bidewell-Sullivan and Katrina Forsyth and Emma Lee and Anna Stanton and Julie Duncan and Guy Chung-Faye and Patrick Dubois and Nick Powell and Simon Anderson and Jeremy Sanderson and Bu'Hussain Hayee and Irving, {Peter M}",

year = "2017",

month = jul,

doi = "10.1136/flgastro-2016-100720",

language = "English",

volume = "8",

pages = "196--202",

journal = "Frontline Gastroenterology",

issn = "2041-4137",

publisher = "BMJ Publishing Group",

number = "3",

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Samaan, MA, Pavlidis, P, Johnston, E, Warner, B, Digby-Bell, J, Koumoutsos, I, Fong, S, Goldberg, R, Patel, K, Gulati, S, Medcalf, L, Sastrillo, M, Brown-Clarke, C, Bidewell-Sullivan, J, Forsyth, K, Lee, E, Stanton, A, Duncan, J, Chung-Faye, G, Dubois, P, Powell, N, Anderson, S, Sanderson, J, Hayee, BH & Irving, PM 2017, 'Vedolizumab: early experience and medium-term outcomes from two UK tertiary IBD centres', Frontline Gastroenterology, vol. 8, no. 3, pp. 196-202. https://doi.org/10.1136/flgastro-2016-100720

TY - JOUR

T1 - Vedolizumab

T2 - early experience and medium-term outcomes from two UK tertiary IBD centres

AU - Samaan, Mark A

AU - Pavlidis, Polychronis

AU - Johnston, Emma

AU - Warner, Ben

AU - Digby-Bell, Jonathan

AU - Koumoutsos, Ioannis

AU - Fong, Steven

AU - Goldberg, Rimma

AU - Patel, Kamal

AU - Gulati, Shraddha

AU - Medcalf, Lucy

AU - Sastrillo, Marlene

AU - Brown-Clarke, Cordella

AU - Bidewell-Sullivan, Johanna

AU - Forsyth, Katrina

AU - Lee, Emma

AU - Stanton, Anna

AU - Duncan, Julie

AU - Chung-Faye, Guy

AU - Dubois, Patrick

AU - Powell, Nick

AU - Anderson, Simon

AU - Sanderson, Jeremy

AU - Hayee, Bu'Hussain

AU - Irving, Peter M

PY - 2017/7

Y1 - 2017/7

N2 - OBJECTIVE: To gain an understanding of the efficacy of vedolizumab in a 'real-world' setting.DESIGN: Retrospective cohort study using prospectively maintained clinical records.SETTING: Two UK tertiary inflammatory bowel disease (IBD) centres.PATIENTS: Patients with IBD commenced on vedolizumab at Guy's & St Thomas' and King's College Hospitals during November 2014-November 2015.INTERVENTION: Vedolizumab, a monoclonal antibody to α-4 β-7 integrins that selectively inhibit leucocyte migration into the gut.MAIN OUTCOME MEASURES: Clinical disease activity was assessed at baseline, weeks 14 and 30 using Harvey-Bradshaw Index (HBI) for Crohn's disease (CD) and Simple Clinical Colitis Activity Index (SCCAI) for ulcerative colitis (UC). Response was defined as HBI or SCCAI reduction ≥3. Remission was defined as HBI <5 or SCCAI <3. Continuous data are summarised as medians, followed by range.RESULTS: Fifty patients were included: 27 CD, 20 UC and 3 IBD-U (included in the UC group for analysis). At baseline visit, the median HBI was 8 (1-16) and SCCAI was 6 (0-15). At week 14, these values had fallen to 5 (0-15) (p=0.117) and 4 (0-10) (p=0.005), respectively. Additionally, week 30 data were available for 19 patients (9 CD, 10 UC). The clinical disease activity scores at that point were HBI 2 (0-7) (p=0.039) and SCCAI 2 (0-10) (p=0.023). At baseline, 37 (74%) of the 50 patients had clinically active disease. Of the patients with active disease, 22 (59%) responded and 14 (38%) achieved remission at week 14.CONCLUSIONS: Our early experience with vedolizumab demonstrates a clear benefit in terms of disease control as well as a steroid-sparing effect in a cohort, which included patients with complex and previously refractory disease.

AB - OBJECTIVE: To gain an understanding of the efficacy of vedolizumab in a 'real-world' setting.DESIGN: Retrospective cohort study using prospectively maintained clinical records.SETTING: Two UK tertiary inflammatory bowel disease (IBD) centres.PATIENTS: Patients with IBD commenced on vedolizumab at Guy's & St Thomas' and King's College Hospitals during November 2014-November 2015.INTERVENTION: Vedolizumab, a monoclonal antibody to α-4 β-7 integrins that selectively inhibit leucocyte migration into the gut.MAIN OUTCOME MEASURES: Clinical disease activity was assessed at baseline, weeks 14 and 30 using Harvey-Bradshaw Index (HBI) for Crohn's disease (CD) and Simple Clinical Colitis Activity Index (SCCAI) for ulcerative colitis (UC). Response was defined as HBI or SCCAI reduction ≥3. Remission was defined as HBI <5 or SCCAI <3. Continuous data are summarised as medians, followed by range.RESULTS: Fifty patients were included: 27 CD, 20 UC and 3 IBD-U (included in the UC group for analysis). At baseline visit, the median HBI was 8 (1-16) and SCCAI was 6 (0-15). At week 14, these values had fallen to 5 (0-15) (p=0.117) and 4 (0-10) (p=0.005), respectively. Additionally, week 30 data were available for 19 patients (9 CD, 10 UC). The clinical disease activity scores at that point were HBI 2 (0-7) (p=0.039) and SCCAI 2 (0-10) (p=0.023). At baseline, 37 (74%) of the 50 patients had clinically active disease. Of the patients with active disease, 22 (59%) responded and 14 (38%) achieved remission at week 14.CONCLUSIONS: Our early experience with vedolizumab demonstrates a clear benefit in terms of disease control as well as a steroid-sparing effect in a cohort, which included patients with complex and previously refractory disease.

U2 - 10.1136/flgastro-2016-100720

DO - 10.1136/flgastro-2016-100720

M3 - Article

C2 - 28839909

SN - 2041-4137

VL - 8

SP - 196

EP - 202

JO - Frontline Gastroenterology

JF - Frontline Gastroenterology

IS - 3

ER -

Vedolizumab: early experience and medium-term outcomes from two UK tertiary IBD centres

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