TY - JOUR
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.
N1 - Funding Information:
Conflicts of interest These authors disclose the following: Parambir S. Desai: Research support, travel support, and honorarium from Takeda, research support from Pfizer. Brigid S. Boland: Research support from Takeda, and support from CCFA career development award and UCSD KL2 (1KL2TR001444). Siddharth Singh: Research support from Pfizer, and support from the American College of Gastroenterology and the Crohn's and Colitis Foundation. Jenna L. Koliani-Pace: Travel support from Takeda. Eugenia Shmidt: Travel support from Takeda. Sunanda Kane: Consulting Abbvie. Research Support Takeda, Abbvie, Pfizer, Genentech, Celgene. Dana Lukin: Consulting for Abbive, Salix. David Hudesman: Consulting for Abbvie, Takeda, Janssen. Bo Shen: Consulting for Janssen, Salix, Abbvie, Takeda, Theravence, Robarts Clinical Trials. Corey A. Siegel: Consulting for Abbvie, Amgen, Celgene, Lilly, Janssen, Sandoz, Pfizer, Prometheus, Takeda; speaker for CME activities for Abbvie, Janssen, Pfizer, Takeda; grant support from Abbvie, Janssen, Pfizer and Takeda. Edward V. Loftus Jr: Consulting for Janssen, Takeda, AbbVie, UCB, Amgen, Pfizer, Salix, Mesoblast, Eli Lilly, Celgene, and CVS Caremark; research support from Janssen, Takeda, AbbVie, UCB, Amgen, Pfizer, Genentech, Gilead, Receptos, Celgene, MedImmune, Seres Therapeutics, and Robarts Clinical Trials. Sunanda Kane: Consultant to AbbVie, Janssen, Merck, Spherix Health, Pfizer, UCB. Research support from UCB. Board member ABIM Bruce E. Sands: Consulting and research support from Amgen, Celgene, Janssen, Pfizer, Prometheus Laboratories, Takeda; consulting for AbbVie, Akros Pharma, Arena Pharmaceuticals, AstraZeneca, Boehringer-Ingelheim, Bristol-Myers Squibb, Cowen Services Company, Forest Research Institute, Forward Pharma, Immune Pharmaceuticals, Lilly, Receptos, Salix Pharmaceuticals, Shire, Synergy Pharmaceuticals, Theravance Biopharma R&D, TiGenix, TopVert Pharma, UCB Vivelix Pharmaceuticals, Target Pharmasolutions, Allergan. Jean-Frederic Colombel: Consultancy/advisory board membership: AbbVie, Amgen, Boehringer-Ingelheim, Celgene Corporation, Celltrion, Enterome, Ferring, Genentech, Janssen and Janssen, Medimmune, Merck & Co., Pfizer, Protagonist, Second Genome, Seres, Takeda, Theradiag; Speaker: AbbVie, Ferring, Takeda, Shire; Research support: AbbVie, Janssen and Janssen, Genentech, Takeda; Stock options: Intestinal Biotech Development, Genfit. William J. Sandborn: Personal fees from Kyowa Hakko Kirin, Millennium Pharmaceuticals, Celgene Cellular Therapeutics, Santarus, Salix Pharmaceuticals, Catabasis Pharmaceuticals, Vertex Pharmaceuticals, Warner Chilcott, Cosmo Pharmaceuticals, Ferring Pharmaceuticals, Sigmoid Biotechnologies, Tillotts Pharma, Am Pharma BV, Dr August Wolff, Avaxia Biologics, Zyngenia, Ironwood Pharmaceuticals, Index Pharmaceuticals, Nestle, Lexicon Pharmaceuticals, UCB Pharma, Orexigen, Luitpold Pharmaceuticals, Baxter Healthcare, Ferring Research Institute, Novo Nordisk, Mesoblast Inc., Shire, Ardelyx Inc., Actavis, Seattle Genetics, MedImmune (AstraZeneca), Actogenix NV, Lipid Therapeutics Gmbh, Eisai, Qu Biologics, Toray Industries Inc, Teva Pharmaceuticals, Eli Lilly, Chiasma, TiGenix, Adherion Therapeutics, Immune Pharmaceuticals, Celgene, Arena Pharmaceuticals, personal fees from Ambrx Inc., Akros Pharma, Vascular Biogenics, Theradiag, Forward Pharma, Regeneron, Galapagos, Seres Health, Ritter Pharmaceuticals, Theravance, Palatin, Biogen, University of Western Ontario (owner of Robarts Clinical Trials); grants and personal fees from Prometheus Laboratories, AbbVie, Gilead Sciences, Boehringer Ingelheim, Amgen, Takeda, Atlantic Pharmaceuticals, Bristol-Myers Squibb Genentech, GlaxoSmithKline, Pfizer, Nutrition Science Partners, Receptos, Amgen; grants, personal fees and nonfinancial support from Janssen; grants from Broad Foundation, American College of Gastroenterology, Exact Sciences. The remaining authors disclose no conflicts. Funding Takeda Pharmaceuticals provided funding for statistical support to analyze the data. Takeda Pharmaceuticals and associated employees did not have access to any of the data, and all data analyses were performed at the University of California, San Diego, by consortium investigators or statisticians.
PY - 2019/7
Y1 - 2019/7
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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U2 - 10.1016/j.cgh.2018.09.035
DO - 10.1016/j.cgh.2018.09.035
M3 - Article
C2 - 30268561
AN - SCOPUS:85067303409
VL - 17
SP - 1533-1540.e2
JO - Clinical Gastroenterology and Hepatology
JF - Clinical Gastroenterology and Hepatology
SN - 1542-3565
IS - 8
ER -