TY - JOUR
T1 - Comparative safety and effectiveness of vedolizumab to tumour necrosis factor antagonist therapy for Crohn's disease
AU - the VICTORY Collaboration
AU - Bohm, Matthew
AU - Xu, Ronghui
AU - Zhang, Yiran
AU - Varma, Sashidhar
AU - Fischer, Monika
AU - Kochhar, Gursimran
AU - Boland, Brigid
AU - Singh, Siddharth
AU - Hirten, Robert
AU - Ungaro, Ryan
AU - Shmidt, Eugenia
AU - Lasch, Karen
AU - Jairaith, Vipul
AU - Hudesman, David
AU - Chang, Shannon
AU - Lukin, Dana
AU - Swaminath, Arun
AU - Sands, Bruce E.
AU - Colombel, Jean Frederic
AU - Kane, Sunanda
AU - Loftus, Edward V.
AU - Shen, Bo
AU - Siegel, Corey A.
AU - Sandborn, William J.
AU - Dulai, Parambir S.
AU - Kadire, Siri
AU - Tran, Gloria
AU - Rahal, Mahmoud
AU - Aniwan, Satimai
AU - Meserve, Joseph
AU - Weiss, Aaron
AU - Koliani-Pace, Jenna L.
AU - Campbell, James P.
AU - Faleck, David
AU - Winters, Adam
AU - Chablaney, Shreya
N1 - Publisher Copyright:
© 2020 The Authors. Alimentary Pharmacology & Therapeutics published by John Wiley & Sons Ltd
PY - 2020/8
Y1 - 2020/8
N2 - Background: Direct comparisons are lacking between vedolizumab and tumour necrosis factor (TNF)-antagonist therapy in Crohn's disease (CD). Aim: To compare safety and effectiveness of vedolizumab and TNF-antagonist therapy in adult CD patients. Methods: Retrospective observational cohort (May 2014–December 2017) propensity score-weighted comparison of vedolizumab vs TNF-antagonist therapy (infliximab, adalimumab, certolizumab) in CD. Propensity scores were weighted for age, prior treatments, disease complications, extent and severity, steroid dependence, and concomitant immunosuppressive drug use. The primary outcome was comparative risk for infections or non-infectious serious adverse events (requiring antibiotics, antivirals, antifungals, hospitalisation, or treatment discontinuation, or resulting in death). Secondary comparative effectiveness outcomes were clinical remission (resolution of CD-related symptoms), steroid-free clinical remission and endoscopic remission (absence of ulcers/erosions). Results: We included 1266 patients (n = 659 vedolizumab). Rates of non-infectious serious adverse events (odds ratio [OR] 0.072, 95% confidence interval [CI] 0.012-0.242), but not serious infections (OR 1.183, 95% CI 0.786-1.795), were significantly lower with vedolizumab vs TNF-antagonist therapy. Safety comparisons for non-infectious serious adverse events remained significant after adjusting for differences in duration of exposure. No significant difference was observed between vedolizumab and TNF-antagonist therapy for clinical remission (hazard ratio [HR] 0.932, 95% CI 0.707-1.228), steroid-free clinical remission (HR 1.250, 95% CI 0.677-2.310) or endoscopic remission (HR 0.827, 95% CI 0.595-1.151). TNF-antagonist therapy was associated with higher treatment persistence compared with vedolizumab. Conclusions: There was a lower risk of non-infectious serious adverse events, but not serious infections, with vedolizumab vs TNF-antagonist therapy, with no significant difference for achieving disease remission.
AB - Background: Direct comparisons are lacking between vedolizumab and tumour necrosis factor (TNF)-antagonist therapy in Crohn's disease (CD). Aim: To compare safety and effectiveness of vedolizumab and TNF-antagonist therapy in adult CD patients. Methods: Retrospective observational cohort (May 2014–December 2017) propensity score-weighted comparison of vedolizumab vs TNF-antagonist therapy (infliximab, adalimumab, certolizumab) in CD. Propensity scores were weighted for age, prior treatments, disease complications, extent and severity, steroid dependence, and concomitant immunosuppressive drug use. The primary outcome was comparative risk for infections or non-infectious serious adverse events (requiring antibiotics, antivirals, antifungals, hospitalisation, or treatment discontinuation, or resulting in death). Secondary comparative effectiveness outcomes were clinical remission (resolution of CD-related symptoms), steroid-free clinical remission and endoscopic remission (absence of ulcers/erosions). Results: We included 1266 patients (n = 659 vedolizumab). Rates of non-infectious serious adverse events (odds ratio [OR] 0.072, 95% confidence interval [CI] 0.012-0.242), but not serious infections (OR 1.183, 95% CI 0.786-1.795), were significantly lower with vedolizumab vs TNF-antagonist therapy. Safety comparisons for non-infectious serious adverse events remained significant after adjusting for differences in duration of exposure. No significant difference was observed between vedolizumab and TNF-antagonist therapy for clinical remission (hazard ratio [HR] 0.932, 95% CI 0.707-1.228), steroid-free clinical remission (HR 1.250, 95% CI 0.677-2.310) or endoscopic remission (HR 0.827, 95% CI 0.595-1.151). TNF-antagonist therapy was associated with higher treatment persistence compared with vedolizumab. Conclusions: There was a lower risk of non-infectious serious adverse events, but not serious infections, with vedolizumab vs TNF-antagonist therapy, with no significant difference for achieving disease remission.
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U2 - 10.1111/apt.15921
DO - 10.1111/apt.15921
M3 - Article
C2 - 32656800
AN - SCOPUS:85087818782
SN - 0269-2813
VL - 52
SP - 669
EP - 681
JO - Alimentary Pharmacology and Therapeutics
JF - Alimentary Pharmacology and Therapeutics
IS - 4
ER -