Retrospective Analysis of Safety of Vedolizumab in Patients With Inflammatory Bowel Diseases

Joseph Meserve, Satimai Aniwan, Jenna L. Koliani-Pace, Preeti Shashi, Aaron Weiss, David Faleck, Adam Winters, Shreva Chablaney, Gursimran Kochhar, Brigid S. Boland, Siddharth Singh, Robert Hirten, Eugenia Shmidt, Justin G. Hartke, Prianka Chilukuri, Matthew Bohm, Sashidhar Varma Sagi, Monika Fischer, Dana Lukin, David HudesmanShannon Chang, Youran Gao, Keith Sultan, Arun Swaminath, Nitin Gupta, Sunanda Kane, Edward V. Loftus, Bo Shen, Bruce E. Sands, Jean Frederic Colombel, Corey A. Siegel, William J. Sandborn, Parambir S. Dulai

Research output: Contribution to journalArticle

3 Citations (Scopus)

Abstract

Background & Aims: There are few real-world data on the safety of vedolizumab for treatment of Crohn's disease (CD) or ulcerative colitis (UC). We quantified rates and identified factors significantly associated with infectious and non-infectious adverse events in clinical practice. Methods: We performed a retrospective review of data from a multicenter consortium database (from May 2014 through June 2017). Infectious and non-infectious adverse events were defined as those requiring antibiotics, hospitalization, vedolizumab discontinuation, or resulting in death. Rates were quantified as proportions and events per 100 patient years of exposure (PYE) or follow up (PYF). We performed multivariable logistic regression analyses to identify factors significantly associated with events and reported as odds ratios (OR) with 95% CIs. Results: Our analysis comprised 1087 patients (650 with CD and 437 with UC; 55% female; median age, 37 years) with 861 PYE and 955 PYF. Infections were observed in 68 patients (6.3%; 7.9 per 100 PYE, 7.1 per 100 PYF); gastrointestinal infections (n = 31, 2.4 per 100 PYE, 2.2 per 100 PYF) and respiratory infections (n = 14, 1.6 per 100 PYE, 1.5 per 100 PYF) were the most common. Arthralgias were the most common non-infectious adverse events (n = 31, 2.9%; 3.6 per 100 PYE). Two patients developed malignancies (squamous cell skin cancer and colorectal cancer; 0.23 per 100 PYE, 0.21 per 100 PYF). Active smoker status (OR, 3.39) and number of concomitant immunosuppressive agents (corticosteroids or immunomodulators; OR, 1.72 per agent) used were independently associated with infections. Conclusion: In a retrospective cohort study of patients with IBD, we found vedolizumab to be well tolerated with an overall favorable safety profile. Active smoking and concomitant use of immunosuppressive agents were independently associated with infections

Original languageEnglish (US)
Pages (from-to)1533-1540.e2
JournalClinical Gastroenterology and Hepatology
Volume17
Issue number8
DOIs
StatePublished - Jul 1 2019

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Inflammatory Bowel Diseases
Safety
Odds Ratio
Immunosuppressive Agents
Infection
Ulcerative Colitis
Crohn Disease
vedolizumab
Squamous Cell Neoplasms
Arthralgia
Immunologic Factors
Skin Neoplasms
Respiratory Tract Infections
Colorectal Neoplasms
Adrenal Cortex Hormones
Hospitalization
Cohort Studies
Retrospective Studies
Logistic Models
Smoking

Keywords

  • AE
  • Drug
  • IBD
  • α4β7 Integrin

ASJC Scopus subject areas

  • Hepatology
  • Gastroenterology

Cite this

Meserve, J., Aniwan, S., Koliani-Pace, J. L., Shashi, P., Weiss, A., Faleck, D., ... Dulai, P. S. (2019). Retrospective Analysis of Safety of Vedolizumab in Patients With Inflammatory Bowel Diseases. Clinical Gastroenterology and Hepatology, 17(8), 1533-1540.e2. https://doi.org/10.1016/j.cgh.2018.09.035

Retrospective Analysis of Safety of Vedolizumab in Patients With Inflammatory Bowel Diseases. / Meserve, Joseph; Aniwan, Satimai; Koliani-Pace, Jenna L.; Shashi, Preeti; Weiss, Aaron; Faleck, David; Winters, Adam; Chablaney, Shreva; Kochhar, Gursimran; Boland, Brigid S.; Singh, Siddharth; Hirten, Robert; Shmidt, Eugenia; Hartke, Justin G.; Chilukuri, Prianka; Bohm, Matthew; Sagi, Sashidhar Varma; Fischer, Monika; Lukin, Dana; Hudesman, David; Chang, Shannon; Gao, Youran; Sultan, Keith; Swaminath, Arun; Gupta, Nitin; Kane, Sunanda; Loftus, Edward V.; Shen, Bo; Sands, Bruce E.; Colombel, Jean Frederic; Siegel, Corey A.; Sandborn, William J.; Dulai, Parambir S.

In: Clinical Gastroenterology and Hepatology, Vol. 17, No. 8, 01.07.2019, p. 1533-1540.e2.

Research output: Contribution to journalArticle

Meserve, J, Aniwan, S, Koliani-Pace, JL, Shashi, P, Weiss, A, Faleck, D, Winters, A, Chablaney, S, Kochhar, G, Boland, BS, Singh, S, Hirten, R, Shmidt, E, Hartke, JG, Chilukuri, P, Bohm, M, Sagi, SV, Fischer, M, Lukin, D, Hudesman, D, Chang, S, Gao, Y, Sultan, K, Swaminath, A, Gupta, N, Kane, S, Loftus, EV, Shen, B, Sands, BE, Colombel, JF, Siegel, CA, Sandborn, WJ & Dulai, PS 2019, 'Retrospective Analysis of Safety of Vedolizumab in Patients With Inflammatory Bowel Diseases', Clinical Gastroenterology and Hepatology, vol. 17, no. 8, pp. 1533-1540.e2. https://doi.org/10.1016/j.cgh.2018.09.035
Meserve, Joseph ; Aniwan, Satimai ; Koliani-Pace, Jenna L. ; Shashi, Preeti ; Weiss, Aaron ; Faleck, David ; Winters, Adam ; Chablaney, Shreva ; Kochhar, Gursimran ; Boland, Brigid S. ; Singh, Siddharth ; Hirten, Robert ; Shmidt, Eugenia ; Hartke, Justin G. ; Chilukuri, Prianka ; Bohm, Matthew ; Sagi, Sashidhar Varma ; Fischer, Monika ; Lukin, Dana ; Hudesman, David ; Chang, Shannon ; Gao, Youran ; Sultan, Keith ; Swaminath, Arun ; Gupta, Nitin ; Kane, Sunanda ; Loftus, Edward V. ; Shen, Bo ; Sands, Bruce E. ; Colombel, Jean Frederic ; Siegel, Corey A. ; Sandborn, William J. ; Dulai, Parambir S. / Retrospective Analysis of Safety of Vedolizumab in Patients With Inflammatory Bowel Diseases. In: Clinical Gastroenterology and Hepatology. 2019 ; Vol. 17, No. 8. pp. 1533-1540.e2.
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abstract = "Background & Aims: There are few real-world data on the safety of vedolizumab for treatment of Crohn's disease (CD) or ulcerative colitis (UC). We quantified rates and identified factors significantly associated with infectious and non-infectious adverse events in clinical practice. Methods: We performed a retrospective review of data from a multicenter consortium database (from May 2014 through June 2017). Infectious and non-infectious adverse events were defined as those requiring antibiotics, hospitalization, vedolizumab discontinuation, or resulting in death. Rates were quantified as proportions and events per 100 patient years of exposure (PYE) or follow up (PYF). We performed multivariable logistic regression analyses to identify factors significantly associated with events and reported as odds ratios (OR) with 95{\%} CIs. Results: Our analysis comprised 1087 patients (650 with CD and 437 with UC; 55{\%} female; median age, 37 years) with 861 PYE and 955 PYF. Infections were observed in 68 patients (6.3{\%}; 7.9 per 100 PYE, 7.1 per 100 PYF); gastrointestinal infections (n = 31, 2.4 per 100 PYE, 2.2 per 100 PYF) and respiratory infections (n = 14, 1.6 per 100 PYE, 1.5 per 100 PYF) were the most common. Arthralgias were the most common non-infectious adverse events (n = 31, 2.9{\%}; 3.6 per 100 PYE). Two patients developed malignancies (squamous cell skin cancer and colorectal cancer; 0.23 per 100 PYE, 0.21 per 100 PYF). Active smoker status (OR, 3.39) and number of concomitant immunosuppressive agents (corticosteroids or immunomodulators; OR, 1.72 per agent) used were independently associated with infections. Conclusion: In a retrospective cohort study of patients with IBD, we found vedolizumab to be well tolerated with an overall favorable safety profile. Active smoking and concomitant use of immunosuppressive agents were independently associated with infections",
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T1 - Retrospective Analysis of Safety of Vedolizumab in Patients With Inflammatory Bowel Diseases

AU - Meserve, Joseph

AU - Aniwan, Satimai

AU - Koliani-Pace, Jenna L.

AU - Shashi, Preeti

AU - Weiss, Aaron

AU - Faleck, David

AU - Winters, Adam

AU - Chablaney, Shreva

AU - Kochhar, Gursimran

AU - Boland, Brigid S.

AU - Singh, Siddharth

AU - Hirten, Robert

AU - Shmidt, Eugenia

AU - Hartke, Justin G.

AU - Chilukuri, Prianka

AU - Bohm, Matthew

AU - Sagi, Sashidhar Varma

AU - Fischer, Monika

AU - Lukin, Dana

AU - Hudesman, David

AU - Chang, Shannon

AU - Gao, Youran

AU - Sultan, Keith

AU - Swaminath, Arun

AU - Gupta, Nitin

AU - Kane, Sunanda

AU - Loftus, Edward V.

AU - Shen, Bo

AU - Sands, Bruce E.

AU - Colombel, Jean Frederic

AU - Siegel, Corey A.

AU - Sandborn, William J.

AU - Dulai, Parambir S.

PY - 2019/7/1

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N2 - Background & Aims: There are few real-world data on the safety of vedolizumab for treatment of Crohn's disease (CD) or ulcerative colitis (UC). We quantified rates and identified factors significantly associated with infectious and non-infectious adverse events in clinical practice. Methods: We performed a retrospective review of data from a multicenter consortium database (from May 2014 through June 2017). Infectious and non-infectious adverse events were defined as those requiring antibiotics, hospitalization, vedolizumab discontinuation, or resulting in death. Rates were quantified as proportions and events per 100 patient years of exposure (PYE) or follow up (PYF). We performed multivariable logistic regression analyses to identify factors significantly associated with events and reported as odds ratios (OR) with 95% CIs. Results: Our analysis comprised 1087 patients (650 with CD and 437 with UC; 55% female; median age, 37 years) with 861 PYE and 955 PYF. Infections were observed in 68 patients (6.3%; 7.9 per 100 PYE, 7.1 per 100 PYF); gastrointestinal infections (n = 31, 2.4 per 100 PYE, 2.2 per 100 PYF) and respiratory infections (n = 14, 1.6 per 100 PYE, 1.5 per 100 PYF) were the most common. Arthralgias were the most common non-infectious adverse events (n = 31, 2.9%; 3.6 per 100 PYE). Two patients developed malignancies (squamous cell skin cancer and colorectal cancer; 0.23 per 100 PYE, 0.21 per 100 PYF). Active smoker status (OR, 3.39) and number of concomitant immunosuppressive agents (corticosteroids or immunomodulators; OR, 1.72 per agent) used were independently associated with infections. Conclusion: In a retrospective cohort study of patients with IBD, we found vedolizumab to be well tolerated with an overall favorable safety profile. Active smoking and concomitant use of immunosuppressive agents were independently associated with infections

AB - Background & Aims: There are few real-world data on the safety of vedolizumab for treatment of Crohn's disease (CD) or ulcerative colitis (UC). We quantified rates and identified factors significantly associated with infectious and non-infectious adverse events in clinical practice. Methods: We performed a retrospective review of data from a multicenter consortium database (from May 2014 through June 2017). Infectious and non-infectious adverse events were defined as those requiring antibiotics, hospitalization, vedolizumab discontinuation, or resulting in death. Rates were quantified as proportions and events per 100 patient years of exposure (PYE) or follow up (PYF). We performed multivariable logistic regression analyses to identify factors significantly associated with events and reported as odds ratios (OR) with 95% CIs. Results: Our analysis comprised 1087 patients (650 with CD and 437 with UC; 55% female; median age, 37 years) with 861 PYE and 955 PYF. Infections were observed in 68 patients (6.3%; 7.9 per 100 PYE, 7.1 per 100 PYF); gastrointestinal infections (n = 31, 2.4 per 100 PYE, 2.2 per 100 PYF) and respiratory infections (n = 14, 1.6 per 100 PYE, 1.5 per 100 PYF) were the most common. Arthralgias were the most common non-infectious adverse events (n = 31, 2.9%; 3.6 per 100 PYE). Two patients developed malignancies (squamous cell skin cancer and colorectal cancer; 0.23 per 100 PYE, 0.21 per 100 PYF). Active smoker status (OR, 3.39) and number of concomitant immunosuppressive agents (corticosteroids or immunomodulators; OR, 1.72 per agent) used were independently associated with infections. Conclusion: In a retrospective cohort study of patients with IBD, we found vedolizumab to be well tolerated with an overall favorable safety profile. Active smoking and concomitant use of immunosuppressive agents were independently associated with infections

KW - AE

KW - Drug

KW - IBD

KW - α4β7 Integrin

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