Cristina Saro1, Daniel Ceballos2, Fernando Muñoz3, Cristóbal de la Coba4, María Dolores Aguilar5, Pablo Lázaro5, Valle García-Sánchez6, Mariola Hernández7, Jesús Barrio8, Ruth de Francisco9, Luis I Fernández10, Manuel Barreiro-de Acosta11. 1. Hospital de Cabueñes. 2. Hospital Dr. Negrín. Las Palmas. 3. Aparato digestivo, Complejo Asistencial Universitario de Salamanca, España. 4. Sección de Aparato Digestivo. , Hospital de Cabueñes, España. 5. Advanced Techniques in Health Services Research. Madrid. 6. Aparato Digestivo, Hospital Universitario Reina Sofía. Córdoba, España. 7. Hospital Virgen del Puerto. Plasencia. 8. Aparato Digestivo, Hospital Río Hortega, España. 9. Hospital Universitario Central de Asturias. 10. Hospital Clínico Universitario Valladolid. 11. Aparato digestivo, Hospital Clínico de Santiago, España.
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. MATERIAL AND 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.
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 diseasepatients receiving adalimumab for one year in the context of usual clinical practice. MATERIAL AND METHODS: This was a prospective, observational study with a one-year follow-up. After baseline, Crohn's diseasepatients 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 diseasepatients and results in a significant improvement in quality of life and work productivity.
Authors: Cristina Calviño-Suárez; Rocío Ferreiro-Iglesias; Iria Bastón-Rey; Manuel Barreiro-de Acosta Journal: Int J Environ Res Public Health Date: 2021-07-04 Impact factor: 3.390
Authors: Åsa H Everhov; Michael C Sachs; Jonas F Ludvigsson; Hamed Khalili; Johan Askling; Martin Neovius; Pär Myrelid; Jonas Halfvarson; Caroline Nordenvall; Jonas Söderling; Ola Olén Journal: Clin Epidemiol Date: 2020-03-10 Impact factor: 4.790