title: Clinical status, quality of life, and work productivity in Crohn's disease patients after one year of treatment with adalimumab.
abstract: OBJECTIVE
  Clinical trials have shown the efficacy of adalimumab in Crohn's disease, but the outcome in regular practice remains unknown. The aim of the study was to examine clinical status, quality of life, and work productivity of Crohn's disease patients receiving adalimumab for one year in the context of usual clinical practice.
  
  
  METHODS
  This was a prospective, observational study with a one-year follow-up. After baseline, Crohn's disease patients were evaluated at 1, 3, 6, 9, and 12 months after starting treatment with adalimumab. Outcome variables included: clinical status (measured with CDAI), quality of life (measured with EuroQoL-5D and IBDQ), and work productivity (measured with WPAI questionnaire). These outcome variables were compared using the Student's t test or Wilcoxon test for paired comparison data according to the data distribution. Statistical significance was set at two-sided p < 0.05.
  
  
  RESULTS
  The sample was composed of 126 patients (age [mean] 39.1 ± [standard deviation] 13.8 years; 51% male). Significant changes were observed during the follow-up period: CDAI decreased from [median] 194 ([25-75 percentiles] 121-269) to 48.2 (10.1-122.0) (p < 0.05); the EuroQoL-5D increased from 0.735 (0.633-0.790) to 0.797 (0.726-1.000) (p < 0.05); the EuroQoL-5D visual analogue scale increased from 50.0 (40-70) to 80.0 (60-90); (p < 0.05) and the IBDQ increased from 56.7 (51.6-61.5) to 67.5 (60.1-73.6) (p < 0.05). The total work productivity impact decreased from 53% to 24% (p < 0.05).
  
  
  CONCLUSIONS
  In regular practice, adalimumab is clinically effective in the treatment of Crohn's disease patients and results in a significant improvement in quality of life and work productivity.
authors.affiliation: Hospital de Cabueñes.
authors.forename: Cristina
authors.initials: C
authors.lastname: Saro
authors.affiliation: Hospital Dr. Negrín. Las Palmas.
authors.forename: Daniel
authors.initials: D
authors.lastname: Ceballos
authors.affiliation: Aparato digestivo, Complejo Asistencial Universitario de Salamanca, España.
authors.forename: Fernando
authors.initials: F
authors.lastname: Muñoz
authors.affiliation: Sección de Aparato Digestivo. , Hospital de Cabueñes, España.
authors.forename: Cristóbal
authors.initials: C
authors.lastname: de la Coba
authors.affiliation: Advanced Techniques in Health Services Research. Madrid.
authors.forename: María Dolores
authors.initials: MD
authors.lastname: Aguilar
authors.affiliation: Advanced Techniques in Health Services Research. Madrid.
authors.forename: Pablo
authors.initials: P
authors.lastname: Lázaro
authors.affiliation: Aparato Digestivo, Hospital Universitario Reina Sofía. Córdoba, España.
authors.forename: Valle
authors.initials: V
authors.lastname: García-Sánchez
authors.affiliation: Hospital Virgen del Puerto. Plasencia.
authors.forename: Mariola
authors.initials: M
authors.lastname: Hernández
authors.affiliation: Aparato Digestivo, Hospital Río Hortega, España.
authors.forename: Jesús
authors.initials: J
authors.lastname: Barrio
authors.affiliation: Hospital Universitario Central de Asturias.
authors.forename: Ruth
authors.initials: R
authors.lastname: de Francisco
authors.affiliation: Hospital Clínico Universitario Valladolid.
authors.forename: Luis I
authors.initials: LI
authors.lastname: Fernández
authors.affiliation: Aparato digestivo, Hospital Clínico de Santiago, España.
authors.forename: Manuel
authors.initials: M
authors.lastname: Barreiro-de Acosta
mesh_terms: D000068879:Adalimumab / Q000627:therapeutic use*; D000328:Adult; D000368:Aged; D003424:Crohn Disease / Q000188:drug therapy* / Q000503:physiopathology / Q000523:psychology; D004526:Efficiency; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007166:Immunosuppressive Agents / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D011788:Quality of Life; D016896:Treatment Outcome; D014937:Work; D055815:Young Adult
chemical_list: D007166:Immunosuppressive Agents; D000068879:Adalimumab