Comparative Efficacy of Vedolizumab and Adalimumab in Ulcerative Colitis Patients Previously Treated With Infliximab

Italian Group for the Study of Inflammatory Bowel Disease (IG-IBD), Agnese Favale, Sara Onali, Flavio Caprioli, Daniela Pugliese, Alessandro Armuzzi, Fabio Salvatore Macaluso, Ambrogio Orlando, Anna Viola, Walter Fries, Antonio Rispo, Fabiana Castiglione, Giammarco Mocci, Fabio Chicco, Paolo Usai, Emma Calabrese, Livia Biancone, Giovanni Monteleone, Massimo Claudio Fantini

Research output: Contribution to journalArticle

Abstract

BACKGROUND: Adalimumab (ADA) and vedolizumab (VDZ) have shown efficacy in moderate to severe ulcerative colitis (UC) patients who failed infliximab (IFX). Although, a comparative efficacy evaluation of ADA and VDZ in this clinical setting is currently missing. AIM: The aim of this study is to compare the efficacy of ADA and VDZ in patients affected by UC who failed IFX. METHODS: Clinical records of UC patients from 8 Italian IBD referral centers who failed IFX and were candidates to receive either ADA or VDZ were retrospectively reviewed. The primary end point was therapeutic failure at week 52. Secondary end points included therapy discontinuation at weeks 8, 24 and 52, the discontinuation-free survival, and safety. RESULTS: One hundred sixty-one UC patients, 15 (9.2%) primary, 83 (51.6%) secondary IFX failures, and 63 (39.2%) IFX intolerants were included. Sixty-four (40%) patients received ADA and 97 (60%) VDZ as second line therapy. At week 52, 37.5% and 28.9% of patients on ADA and VDZ, respectively, had therapeutic failure (P = 0.302). However, the failure rate was significantly higher in the ADA group as compared with VDZ group among IFX secondary failures (48.0% ADA vs 22.4%VDZ, P = 0.035). The therapy discontinuation-free survival was significantly higher in the group of IFX secondary failures who received VDZ as compared with ADA at both the univariate (P = 0.007) and multivariate survival analysis (OR 2.79; 95% CI, 1.23-6.34; P = 0.014). No difference in the failure and biologic discontinuation-free survival was observed in the IFX primary failure and intolerant subgroups. CONCLUSION: Vedolizumab might be the therapy of choice in those UC patients who showed secondary failure to IFX.

Original languageEnglish
Pages (from-to)1805-1812
Number of pages8
JournalInflammatory Bowel Diseases
Volume25
Issue number11
DOIs
Publication statusPublished - Oct 18 2019

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Ulcerative Colitis
Survival
Therapeutics
vedolizumab
Adalimumab
Infliximab
Survival Analysis
Referral and Consultation
Multivariate Analysis
Safety

Keywords

  • biologics
  • inflammatory bowel disease
  • ulcerative colitis

ASJC Scopus subject areas

  • Immunology and Allergy
  • Gastroenterology

Cite this

Italian Group for the Study of Inflammatory Bowel Disease (IG-IBD), Favale, A., Onali, S., Caprioli, F., Pugliese, D., Armuzzi, A., ... Fantini, M. C. (2019). Comparative Efficacy of Vedolizumab and Adalimumab in Ulcerative Colitis Patients Previously Treated With Infliximab. Inflammatory Bowel Diseases, 25(11), 1805-1812. https://doi.org/10.1093/ibd/izz057

Comparative Efficacy of Vedolizumab and Adalimumab in Ulcerative Colitis Patients Previously Treated With Infliximab. / Italian Group for the Study of Inflammatory Bowel Disease (IG-IBD); Favale, Agnese; Onali, Sara; Caprioli, Flavio; Pugliese, Daniela; Armuzzi, Alessandro; Macaluso, Fabio Salvatore; Orlando, Ambrogio; Viola, Anna; Fries, Walter; Rispo, Antonio; Castiglione, Fabiana; Mocci, Giammarco; Chicco, Fabio; Usai, Paolo; Calabrese, Emma; Biancone, Livia; Monteleone, Giovanni; Fantini, Massimo Claudio.

In: Inflammatory Bowel Diseases, Vol. 25, No. 11, 18.10.2019, p. 1805-1812.

Research output: Contribution to journalArticle

Italian Group for the Study of Inflammatory Bowel Disease (IG-IBD), Favale, A, Onali, S, Caprioli, F, Pugliese, D, Armuzzi, A, Macaluso, FS, Orlando, A, Viola, A, Fries, W, Rispo, A, Castiglione, F, Mocci, G, Chicco, F, Usai, P, Calabrese, E, Biancone, L, Monteleone, G & Fantini, MC 2019, 'Comparative Efficacy of Vedolizumab and Adalimumab in Ulcerative Colitis Patients Previously Treated With Infliximab', Inflammatory Bowel Diseases, vol. 25, no. 11, pp. 1805-1812. https://doi.org/10.1093/ibd/izz057
Italian Group for the Study of Inflammatory Bowel Disease (IG-IBD), Favale A, Onali S, Caprioli F, Pugliese D, Armuzzi A et al. Comparative Efficacy of Vedolizumab and Adalimumab in Ulcerative Colitis Patients Previously Treated With Infliximab. Inflammatory Bowel Diseases. 2019 Oct 18;25(11):1805-1812. https://doi.org/10.1093/ibd/izz057
Italian Group for the Study of Inflammatory Bowel Disease (IG-IBD) ; Favale, Agnese ; Onali, Sara ; Caprioli, Flavio ; Pugliese, Daniela ; Armuzzi, Alessandro ; Macaluso, Fabio Salvatore ; Orlando, Ambrogio ; Viola, Anna ; Fries, Walter ; Rispo, Antonio ; Castiglione, Fabiana ; Mocci, Giammarco ; Chicco, Fabio ; Usai, Paolo ; Calabrese, Emma ; Biancone, Livia ; Monteleone, Giovanni ; Fantini, Massimo Claudio. / Comparative Efficacy of Vedolizumab and Adalimumab in Ulcerative Colitis Patients Previously Treated With Infliximab. In: Inflammatory Bowel Diseases. 2019 ; Vol. 25, No. 11. pp. 1805-1812.
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abstract = "BACKGROUND: Adalimumab (ADA) and vedolizumab (VDZ) have shown efficacy in moderate to severe ulcerative colitis (UC) patients who failed infliximab (IFX). Although, a comparative efficacy evaluation of ADA and VDZ in this clinical setting is currently missing. AIM: The aim of this study is to compare the efficacy of ADA and VDZ in patients affected by UC who failed IFX. METHODS: Clinical records of UC patients from 8 Italian IBD referral centers who failed IFX and were candidates to receive either ADA or VDZ were retrospectively reviewed. The primary end point was therapeutic failure at week 52. Secondary end points included therapy discontinuation at weeks 8, 24 and 52, the discontinuation-free survival, and safety. RESULTS: One hundred sixty-one UC patients, 15 (9.2{\%}) primary, 83 (51.6{\%}) secondary IFX failures, and 63 (39.2{\%}) IFX intolerants were included. Sixty-four (40{\%}) patients received ADA and 97 (60{\%}) VDZ as second line therapy. At week 52, 37.5{\%} and 28.9{\%} of patients on ADA and VDZ, respectively, had therapeutic failure (P = 0.302). However, the failure rate was significantly higher in the ADA group as compared with VDZ group among IFX secondary failures (48.0{\%} ADA vs 22.4{\%}VDZ, P = 0.035). The therapy discontinuation-free survival was significantly higher in the group of IFX secondary failures who received VDZ as compared with ADA at both the univariate (P = 0.007) and multivariate survival analysis (OR 2.79; 95{\%} CI, 1.23-6.34; P = 0.014). No difference in the failure and biologic discontinuation-free survival was observed in the IFX primary failure and intolerant subgroups. CONCLUSION: Vedolizumab might be the therapy of choice in those UC patients who showed secondary failure to IFX.",
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T1 - Comparative Efficacy of Vedolizumab and Adalimumab in Ulcerative Colitis Patients Previously Treated With Infliximab

AU - Italian Group for the Study of Inflammatory Bowel Disease (IG-IBD)

AU - Favale, Agnese

AU - Onali, Sara

AU - Caprioli, Flavio

AU - Pugliese, Daniela

AU - Armuzzi, Alessandro

AU - Macaluso, Fabio Salvatore

AU - Orlando, Ambrogio

AU - Viola, Anna

AU - Fries, Walter

AU - Rispo, Antonio

AU - Castiglione, Fabiana

AU - Mocci, Giammarco

AU - Chicco, Fabio

AU - Usai, Paolo

AU - Calabrese, Emma

AU - Biancone, Livia

AU - Monteleone, Giovanni

AU - Fantini, Massimo Claudio

PY - 2019/10/18

Y1 - 2019/10/18

N2 - BACKGROUND: Adalimumab (ADA) and vedolizumab (VDZ) have shown efficacy in moderate to severe ulcerative colitis (UC) patients who failed infliximab (IFX). Although, a comparative efficacy evaluation of ADA and VDZ in this clinical setting is currently missing. AIM: The aim of this study is to compare the efficacy of ADA and VDZ in patients affected by UC who failed IFX. METHODS: Clinical records of UC patients from 8 Italian IBD referral centers who failed IFX and were candidates to receive either ADA or VDZ were retrospectively reviewed. The primary end point was therapeutic failure at week 52. Secondary end points included therapy discontinuation at weeks 8, 24 and 52, the discontinuation-free survival, and safety. RESULTS: One hundred sixty-one UC patients, 15 (9.2%) primary, 83 (51.6%) secondary IFX failures, and 63 (39.2%) IFX intolerants were included. Sixty-four (40%) patients received ADA and 97 (60%) VDZ as second line therapy. At week 52, 37.5% and 28.9% of patients on ADA and VDZ, respectively, had therapeutic failure (P = 0.302). However, the failure rate was significantly higher in the ADA group as compared with VDZ group among IFX secondary failures (48.0% ADA vs 22.4%VDZ, P = 0.035). The therapy discontinuation-free survival was significantly higher in the group of IFX secondary failures who received VDZ as compared with ADA at both the univariate (P = 0.007) and multivariate survival analysis (OR 2.79; 95% CI, 1.23-6.34; P = 0.014). No difference in the failure and biologic discontinuation-free survival was observed in the IFX primary failure and intolerant subgroups. CONCLUSION: Vedolizumab might be the therapy of choice in those UC patients who showed secondary failure to IFX.

AB - BACKGROUND: Adalimumab (ADA) and vedolizumab (VDZ) have shown efficacy in moderate to severe ulcerative colitis (UC) patients who failed infliximab (IFX). Although, a comparative efficacy evaluation of ADA and VDZ in this clinical setting is currently missing. AIM: The aim of this study is to compare the efficacy of ADA and VDZ in patients affected by UC who failed IFX. METHODS: Clinical records of UC patients from 8 Italian IBD referral centers who failed IFX and were candidates to receive either ADA or VDZ were retrospectively reviewed. The primary end point was therapeutic failure at week 52. Secondary end points included therapy discontinuation at weeks 8, 24 and 52, the discontinuation-free survival, and safety. RESULTS: One hundred sixty-one UC patients, 15 (9.2%) primary, 83 (51.6%) secondary IFX failures, and 63 (39.2%) IFX intolerants were included. Sixty-four (40%) patients received ADA and 97 (60%) VDZ as second line therapy. At week 52, 37.5% and 28.9% of patients on ADA and VDZ, respectively, had therapeutic failure (P = 0.302). However, the failure rate was significantly higher in the ADA group as compared with VDZ group among IFX secondary failures (48.0% ADA vs 22.4%VDZ, P = 0.035). The therapy discontinuation-free survival was significantly higher in the group of IFX secondary failures who received VDZ as compared with ADA at both the univariate (P = 0.007) and multivariate survival analysis (OR 2.79; 95% CI, 1.23-6.34; P = 0.014). No difference in the failure and biologic discontinuation-free survival was observed in the IFX primary failure and intolerant subgroups. CONCLUSION: Vedolizumab might be the therapy of choice in those UC patients who showed secondary failure to IFX.

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