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A propensity score weighted comparison of vedolizumab and adalimumab in Crohn's disease.
Macaluso, Fabio Salvatore; Ventimiglia, Marco; Fries, Walter; Viola, Anna; Sitibondo, Aldo; Cappello, Maria; Scrivo, Barbara; Busacca, Anita; Privitera, Antonino Carlo; Camilleri, Salvatore; Garufi, Serena; Di Mitri, Roberto; Mocciaro, Filippo; Belluardo, Nunzio; Giangreco, Emiliano; Bertolami, Carmelo; Renna, Sara; Orlando, Rosalba; Rizzuto, Giulia; Cottone, Mario; Orlando, Ambrogio.
Afiliação
  • Macaluso FS; Inflammatory Bowel Disease Unit, A.O.O.R. "Villa Sofia-Cervello", Palermo, Italy.
  • Ventimiglia M; Inflammatory Bowel Disease Unit, A.O.O.R. "Villa Sofia-Cervello", Palermo, Italy.
  • Fries W; Inflammatory Bowel Disease Unit, A.O.U. Policlinico "G. Martino", Messina, Italy.
  • Viola A; Inflammatory Bowel Disease Unit, A.O.U. Policlinico "G. Martino", Messina, Italy.
  • Sitibondo A; Inflammatory Bowel Disease Unit, A.O.U. Policlinico "G. Martino", Messina, Italy.
  • Cappello M; Gastroenterology and Hepatology Unit, A.O.U. Policlinico "G. Giaccone", Palermo, Italy.
  • Scrivo B; Gastroenterology and Hepatology Unit, A.O.U. Policlinico "G. Giaccone", Palermo, Italy.
  • Busacca A; Gastroenterology and Hepatology Unit, A.O.U. Policlinico "G. Giaccone", Palermo, Italy.
  • Privitera AC; Inflammatory Bowel Disease Unit, A.O. "Cannizzaro", Catania, Italy.
  • Camilleri S; Gastroenterology Unit, A.O.O.R. "S. Elia- M. Raimondi", Caltanissetta, Italy.
  • Garufi S; Gastroenterology Unit, A.O.O.R. "S. Elia- M. Raimondi", Caltanissetta, Italy.
  • Di Mitri R; Gastroenterology and Endoscopy Unit, A.R.N.A.S. "Civico Di Cristina Benfratelli", Palermo, Italy.
  • Mocciaro F; Gastroenterology and Endoscopy Unit, A.R.N.A.S. "Civico Di Cristina Benfratelli", Palermo, Italy.
  • Belluardo N; Gastroenterology Unit, A.O. "Guzzardi", Vittoria, Italy.
  • Giangreco E; Gastroenterology Unit, A.O. "Guzzardi", Vittoria, Italy.
  • Bertolami C; Gastroenterology Unit, A.O.O.R. "Papardo Piemonte", Messina, Italy.
  • Renna S; Inflammatory Bowel Disease Unit, A.O.O.R. "Villa Sofia-Cervello", Palermo, Italy.
  • Orlando R; Inflammatory Bowel Disease Unit, A.O.O.R. "Villa Sofia-Cervello", Palermo, Italy.
  • Rizzuto G; Inflammatory Bowel Disease Unit, A.O.O.R. "Villa Sofia-Cervello", Palermo, Italy.
  • Cottone M; Inflammatory Bowel Disease Unit, A.O.O.R. "Villa Sofia-Cervello", Palermo, Italy.
  • Orlando A; Inflammatory Bowel Disease Unit, A.O.O.R. "Villa Sofia-Cervello", Palermo, Italy.
J Gastroenterol Hepatol ; 36(1): 105-111, 2021 Jan.
Article em En | MEDLINE | ID: mdl-32428981
ABSTRACT
BACKGROUND AND

AIM:

There are no head-to-head randomized controlled trials between biologics in Crohn's disease (CD). We aimed to perform a multicenter, real-life comparison of the effectiveness of vedolizumab (VDZ) and adalimumab (ADA) in CD.

METHODS:

Data of consecutive patients with CD treated with VDZ and ADA from January 2016 to April 2019 were extracted from the cohort of the Sicilian Network for Inflammatory Bowel Disease. The effectiveness was evaluated at 12, 52 weeks, and as failure-free survival at the end of follow up. Propensity score analysis was performed using the inverse probability of treatment weighting method.

RESULTS:

Five hundred eighty-five treatments (VDZ n = 277; ADA n = 308) were included (median follow-up 56.0 weeks). After 12 weeks, a clinical response was achieved in 64.3% patients treated with VDZ and in 83.1% patients treated with ADA (odds ratio [OR] 0.65, 95% confidence interval [CI] 0.38-1.10, P = 0.107), while at 52 weeks, a clinical response was observed in 54.0% patients treated with VDZ and in 69.1% patients treated with ADA (OR 0.77, 95% CI 0.45-1.31, P = 0.336). Cox survival analysis weighted for propensity score showed no significant difference in the probability of failure-free survival between the two drugs (hazard ratio = 1.20, 95% CI 0.83-1.74, P = 0.340). Post-treatment endoscopic response and mucosal healing rates were similar between the two groups (endoscopic response 35.3% for VDZ and 25.5% for ADA, P = 0.15; mucosal healing 31.8% for VDZ and 33.8% for ADA, P = 0.85).

CONCLUSIONS:

In the first study comparing VDZ and ADA in CD via propensity score analysis, the drugs showed comparable effectiveness and a similar safety profile.
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Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Doença de Crohn / Anticorpos Monoclonais Humanizados / Adalimumab Limite: Adult / Female / Humans / Male / Middle aged Idioma: En Revista: J Gastroenterol Hepatol Assunto da revista: GASTROENTEROLOGIA Ano de publicação: 2021 Tipo de documento: Article País de afiliação: Itália

Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Doença de Crohn / Anticorpos Monoclonais Humanizados / Adalimumab Limite: Adult / Female / Humans / Male / Middle aged Idioma: En Revista: J Gastroenterol Hepatol Assunto da revista: GASTROENTEROLOGIA Ano de publicação: 2021 Tipo de documento: Article País de afiliação: Itália