RESUMEN
BACKGROUND: Both vedolizumab and ustekinumab are approved for the management of Crohn's disease [CD]. Data on which one would be the most beneficial option when anti-tumour necrosis factor [anti-TNF] agents fail are limited. AIMS: To compare the durability, effectiveness, and safety of vedolizumab and ustekinumab after anti-TNF failure or intolerance in CD. METHODS: CD patients from the ENEIDA registry who received vedolizumab or ustekinumab after anti-TNF failure or intolerance were included. Durability and effectiveness were evaluated in both the short and the long term. Effectiveness was defined according to the Harvey-Bradshaw index [HBI]. The safety profile was compared between the two treatments. The propensity score was calculated by the inverse probability weighting method to balance confounder factors. RESULTS: A total of 835 patients from 30 centres were included, 207 treated with vedolizumab and 628 with ustekinumab. Dose intensification was performed in 295 patients. Vedolizumab [vs ustekinumab] was associated with a higher risk of treatment discontinuation (hazard ratio [HR] 2.55, 95% confidence interval [CI]: 2.02-3.21), adjusted by corticosteroids at baseline [HR 1.27; 95% CI: 1.00-1.62], moderate-severe activity in HBI [HR 1.79; 95% CI: 1.20-2.48], and high levels of C-reactive protein at baseline [HR 1.06; 95% CI: 1.02-1.10]. The inverse probability weighting method confirmed these results. Clinical response, remission, and corticosteroid-free clinical remission were higher with ustekinumab than with vedolizumab. Both drugs had a low risk of adverse events with no differences between them. CONCLUSION: In CD patients who have failed anti-TNF agents, ustekinumab seems to be superior to vedolizumab in terms of durability and effectiveness in clinical practice. The safety profile is good and similar for both treatments.
Asunto(s)
Anticuerpos Monoclonales Humanizados , Enfermedad de Crohn , Ustekinumab , Humanos , Ustekinumab/uso terapéutico , Enfermedad de Crohn/tratamiento farmacológico , Inhibidores del Factor de Necrosis Tumoral/uso terapéutico , Inducción de Remisión , Factor de Necrosis Tumoral alfa , Sistema de Registros , Resultado del Tratamiento , Estudios RetrospectivosAsunto(s)
Terapia Biológica , Unidades Hospitalarias/organización & administración , Inmunosupresores/uso terapéutico , Enfermedades Inflamatorias del Intestino/terapia , Selección de Paciente , Anticuerpos Antivirales/sangre , Autoanticuerpos/sangre , Terapia Biológica/efectos adversos , Terapia Biológica/enfermería , Análisis Químico de la Sangre , Protocolos Clínicos , Pruebas Diagnósticas de Rutina , Hospitales Universitarios/organización & administración , Humanos , Inmunosupresores/efectos adversos , Enfermedades Inflamatorias del Intestino/tratamiento farmacológico , Enfermedades Inflamatorias del Intestino/enfermería , Pruebas de Función Hepática , Guías de Práctica Clínica como Asunto , Sociedades Médicas , España , Prueba de Tuberculina , Factor de Necrosis Tumoral alfa/antagonistas & inhibidores , VacunaciónRESUMEN
INTRODUCTION: The management of patients with inflammatory bowel disease (IBD) is associated with a significant use of healthcare resources. In 2009, a digestive diseases nursing consultation, with availability of health telematic media was created in our hospital (CHUVI). The important activity performed in this area encouraged us to quantify the cost savings for the care health system. AIMS: 1) To evaluate the results of the implementation of a telematic IBD consultation. 2) To assess the capacity for resolving problems by nurses. 3) To estimate the potential cost savings of telematic nursing consultation in IBD. MATERIAL AND METHOD: We collected data on telematic activity from 2009 to 2011. The estimated cost saving was calculated by applying the fees for health services published by our National Health Service (SERGAS) for care in new outbreaks of IBD activity. Data were analyzed with SPSS 15.0 RESULTS: There was a significant linear increase on the resolution of telephone demands by nurses (P=.03) and an important decrease of demands needing medical advice (P<.0001). Focusing on IBD outbreak claims (n=452), only 65 patients (14.38%) required medical attention in emergency services, and 33 (7.3%) were hospitalized. Altogether we calculated an average cost saving since 2009 to 2011 of 73,603. CONCLUSIONS: We found a gradual increase in resolving telematic care demands by nurses. Telematic consultation can lead to significant cost savings, which justify the implementation of a digestive diseases nurse consultation.