BACKGROUND: "Real-life" data of retention rate and persistence of adalimumab in inflammatory bowel disease are still limited. AIMS: To analyze retention rate, persistence, and safety of adalimumab in a 9-year real-life cohort of inflammatory bowel disease patients. METHODS: In this observational, retrospective single-center study, all adult patients treated with adalimumab as the first- and second-line biological treatment for steroid-dependent or refractory inflammatory bowel disease between March 2008 and March 2017 were included. Primary outcomes were persistence, retention rate, and adverse events; the secondary outcome was the identification of predictors of withdrawal. RESULTS: Ninety-six out of 181 patients (53%) withdrew their first course of adalimumab. The retention rate was 47% and 46.9% in Crohn's disease and ulcerative colitis patients, respectively; median persistence was 26 and 24 months in CD and UC patients, respectively. The cumulative probability of treatment persistence was 80.2%, 54.5%, and 29.6% and 69.6%, 40.4%, and 21.5% in CD and UC patients, respectively. The incidence rate of any adverse event was 12.5/100 patients-year; severe adverse events were 1.7/100 patients-year. The Cox regression revealed that CD patients with baseline disease duration > 72 months have a higher likelihood for withdrawal due to failure and/or adverse events (HR 1.62, 95% CI 1-2.62, p = 0.04); no predictors of discontinuation were found in UC. CONCLUSIONS: Adalimumab showed a great persistence in the first 12 months of therapy and excellent safety profile. Early treatment of CD patients could increase efficacy and reduce the adverse event rate.
BACKGROUND: "Real-life" data of retention rate and persistence of adalimumab in inflammatory bowel disease are still limited. AIMS: To analyze retention rate, persistence, and safety of adalimumab in a 9-year real-life cohort of inflammatory bowel diseasepatients. METHODS: In this observational, retrospective single-center study, all adult patients treated with adalimumab as the first- and second-line biological treatment for steroid-dependent or refractory inflammatory bowel disease between March 2008 and March 2017 were included. Primary outcomes were persistence, retention rate, and adverse events; the secondary outcome was the identification of predictors of withdrawal. RESULTS: Ninety-six out of 181 patients (53%) withdrew their first course of adalimumab. The retention rate was 47% and 46.9% in Crohn's disease and ulcerative colitispatients, respectively; median persistence was 26 and 24 months in CD and UC patients, respectively. The cumulative probability of treatment persistence was 80.2%, 54.5%, and 29.6% and 69.6%, 40.4%, and 21.5% in CD and UC patients, respectively. The incidence rate of any adverse event was 12.5/100 patients-year; severe adverse events were 1.7/100 patients-year. The Cox regression revealed that CD patients with baseline disease duration > 72 months have a higher likelihood for withdrawal due to failure and/or adverse events (HR 1.62, 95% CI 1-2.62, p = 0.04); no predictors of discontinuation were found in UC. CONCLUSIONS:Adalimumab showed a great persistence in the first 12 months of therapy and excellent safety profile. Early treatment of CD patients could increase efficacy and reduce the adverse event rate.
Authors: Jean-Frédéric Colombel; William J Sandborn; Paul Rutgeerts; Robert Enns; Stephen B Hanauer; Remo Panaccione; Stefan Schreiber; Dan Byczkowski; Ju Li; Jeffrey D Kent; Paul F Pollack Journal: Gastroenterology Date: 2006-11-29 Impact factor: 22.682
Authors: Fernando Gomollón; Axel Dignass; Vito Annese; Herbert Tilg; Gert Van Assche; James O Lindsay; Laurent Peyrin-Biroulet; Garret J Cullen; Marco Daperno; Torsten Kucharzik; Florian Rieder; Sven Almer; Alessandro Armuzzi; Marcus Harbord; Jost Langhorst; Miquel Sans; Yehuda Chowers; Gionata Fiorino; Pascal Juillerat; Gerassimos J Mantzaris; Fernando Rizzello; Stephan Vavricka; Paolo Gionchetti Journal: J Crohns Colitis Date: 2016-09-22 Impact factor: 9.071
Authors: Charlotte P Peters; Emma J Eshuis; Florien M Toxopeüs; Merel E Hellemons; Jeroen M Jansen; Geert R A M D'Haens; Paul Fockens; Pieter C F Stokkers; Hans A R E Tuynman; Adriaan A van Bodegraven; Cyriel Y Ponsioen Journal: J Crohns Colitis Date: 2014-01-31 Impact factor: 9.071
Authors: D Pugliese; L Guidi; P M Ferraro; M Marzo; C Felice; L Celleno; R Landi; G Andrisani; F Pizzolante; I De Vitis; A Papa; G L Rapaccini; A Armuzzi Journal: Aliment Pharmacol Ther Date: 2015-07-31 Impact factor: 8.171
Authors: Stephen B Hanauer; William J Sandborn; Paul Rutgeerts; Richard N Fedorak; Milan Lukas; Donald MacIntosh; Remo Panaccione; Douglas Wolf; Paul Pollack Journal: Gastroenterology Date: 2006-02 Impact factor: 22.682
Authors: Fernando Magro; Paolo Gionchetti; Rami Eliakim; Sandro Ardizzone; Alessandro Armuzzi; Manuel Barreiro-de Acosta; Johan Burisch; Krisztina B Gecse; Ailsa L Hart; Pieter Hindryckx; Cord Langner; Jimmy K Limdi; Gianluca Pellino; Edyta Zagórowicz; Tim Raine; Marcus Harbord; Florian Rieder Journal: J Crohns Colitis Date: 2017-06-01 Impact factor: 10.020