title: [Efficacy and effectiveness of biologic therapy in inflammatory bowel disease. EFIFECT study].
abstract: BACKGROUND
  Randomized controlled trials provide the best scientific evidence for the efficacy of biological drugs in inflammatory bowel disease (IBD). However, findings obtained from these trials might not be reproducible in clinical practice. This study aimed to estimate the percentage of patients with IBD treated with biologics who would have been eligible for randomized controlled trials, and to compare the theoretical efficacy of biological drugs with their effectiveness in clinical practice.
  
  
  METHODS
  We performed a retrospective multicenter study in 375 patients with IBD treated with anti-TNF agents and followed-up for 1 year. The eligibility criteria for the trial were taken from the ACCENT, SONIC, ACT, CLASSIC and CHARM trials. Eligible patients were included in a second analysis to compare results in clinical practice versus those hypothetically obtained if the patient had been included in a trial.
  
  
  RESULTS
  Only 45.6% of 375 patients would have been eligible for pivotal trials. One-year clinical benefit (remission or response) was similar for eligible and non-eligible cohorts (68.4% vs. 68.6%, P=.608). The clinical benefit was greater for current clinical practice than for a hypothetical trial situation (68.4% vs. 44.4%, P<.001) in eligible patients.
  
  
  CONCLUSIONS
  More than half of patients with IBD treated with biologic drugs would not be represented in pivotal trials. The effectiveness of anti-TNF drugs in clinical practice exceeds their theoretical efficacy.
authors.affiliation: Departamento de Gastroenterología, Hospital Universitario Son Espases, Institut d'Investigació Sanitària de Palma, Palma de Mallorca, España. Electronic address: daniel.ginard@gmail.com.
authors.forename: Daniel
authors.initials: D
authors.lastname: Ginard
authors.affiliation: Departamento de Gastroenterología, Hospital Universitario Son Espases, Institut d'Investigació Sanitària de Palma, Palma de Mallorca, España.
authors.forename: Sam
authors.initials: S
authors.lastname: Khorrami
authors.affiliation: Departamento de Gastroenterología, Hospital Universitario Son Espases, Institut d'Investigació Sanitària de Palma, Palma de Mallorca, España.
authors.forename: Leticia
authors.initials: L
authors.lastname: Pérez-Carazo
authors.affiliation: Departamento de Gastroenterología, Hospital Universitario Ramón y Cajal, Madrid, España.
authors.forename: Eduardo
authors.initials: E
authors.lastname: Tavío-Hernández
authors.affiliation: Departamento de Gastroenterología, Hospital Universitario Ramón y Cajal, Madrid, España.
authors.forename: Antonio
authors.initials: A
authors.lastname: López-Sanromán
authors.affiliation: Unidad de Gastroenterología, Complejo Hospitalario de León, León, España.
authors.forename: María
authors.initials: M
authors.lastname: García-Alvarado
authors.affiliation: Unidad de Gastroenterología, Complejo Hospitalario de León, León, España.
authors.forename: Fernando
authors.initials: F
authors.lastname: Muñoz
authors.affiliation: Departamento de Gastroenterología e Instituto de Investigación Sanitaria Gregorio Marañón, Hospital Universitario Gregorio Marañón, Madrid, España.
authors.forename: Luis
authors.initials: L
authors.lastname: Ibáñez-Samaniego
authors.affiliation: Departamento de Gastroenterología e Instituto de Investigación Sanitaria Gregorio Marañón, Hospital Universitario Gregorio Marañón, Madrid, España.
authors.forename: Ignacio
authors.initials: I
authors.lastname: Marín-Jiménez
authors.affiliation: Unitat Atenció Crohn-Colitis, Hospital Universitario Vall d'Hebron, Barcelona, España; Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (Ciberehd), Barcelona, España.
authors.forename: Jorge
authors.initials: J
authors.lastname: Guevara
authors.affiliation: Unitat Atenció Crohn-Colitis, Hospital Universitario Vall d'Hebron, Barcelona, España; Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (Ciberehd), Barcelona, España.
authors.forename: Francesc
authors.initials: F
authors.lastname: Casellas
mesh_terms: D000068879:Adalimumab / Q000627:therapeutic use*; D000328:Adult; D001685:Biological Factors / Q000627:therapeutic use*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D015212:Inflammatory Bowel Diseases / Q000188:drug therapy*; D000069285:Infliximab / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D018579:Patient Selection; D016032:Randomized Controlled Trials as Topic; D012189:Retrospective Studies; D012494:Sampling Studies; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D001685:Biological Factors; D000069285:Infliximab; D000068879:Adalimumab
keywords: Adalimumab; Efectividad; Effectiveness; Efficacy; Eficacia; Enfermedad inflamatoria intestinal; Inflammatory bowel disease; Infliximab