Subcutaneous Infliximab [CT-P13], a True Biologic 2.0. Real Clinical Practice Multicentre Study.

BACKGROUND: Inflammatory bowel disease (IBD), including Crohn's disease and ulcerative colitis, is characterized by chronic relapsing intestinal inflammation. There are few data on the efficacy and safety in clinical practice of infliximab (CT-P13) in subcutaneous formulation (SC) for the treatment of patients with IBD. METHODS: Multicenter, prospective study of patients with IBD in clinical remission, who had their treatment changed from intravenous (IV) infliximab to SC. Two groups of patients were evaluated according to whether they were on IV infliximab treatment at standard or intensified doses before the switch. RESULTS: A total of 30 patients were on standard dosing and another 30 in intensified therapy. Treatment persistence in both groups at 6 months was greater than 95%. In both groups after the change, neither the biomarkers of inflammation nor the activity indices underwent significant changes at 3 and 6 months compared to the baseline value. Similarly, in both groups, infliximab trough levels showed a significant increase 3 and 6 months after the change to SC. No serious adverse events were registered. CONCLUSIONS: The CT-P13 SC brings a new anti-TNF era. Achieving much higher drug levels that are constant over time opens new paths to explore the management of patients with IBD: less immunogenicity, better perianal disease control and higher achievement of mucosal healing.

Information resources used by patients with inflammatory bowel disease: Satisfaction, expectations and information gaps / Recursos de información utilizados por los pacientes con enfermedad inflamatoria intestinal: satisfacción, expectativas y lagunas en la información

BACKGROUND AND PURPOSE: Information received by IBD patients about their disease is of particular importance. The objective of the study was to determine the information resources these patients used, together with their perceived information gaps and expected preferences. Patients and methods: A prospective, observational, cross-sectional study conducted on IBD patients attending 13 Spanish hospitals during 2008. Patients completed a semi-structured 52-question survey. Results: Survey was adequately completed by 379 of 385 patients (98%), of whom 57% had Crohn's disease and 43% ulcerative colitis. Mean patient age was 37.9 years (range, 16–76 years). Gastroenterologists were the most commonly used resource (98%), followed by the Internet (60%), and general practitioners (50%). More than 90% reported good to excellent satisfaction with gastroenterologists, nurses, and patients’ associations. Only 56% considered their information needs to be covered. The Internet was mostly used by young patients and those with a high education level. In the future, 85% of the patients would like to receive information from the gastroenterologists, and 92% by face-to-face interviews. Patients mainly want additional information on treatment (medical and surgical), clinical manifestations, cancer, and mortality risks. They also think that they are poorly informed about their social and work rights, risks of cancer and death, and research trials. Conclusions: Patients with IBD use and prefer gastroenterologists as the main source of information, but only half of them consider their information needs to be covered

ANTECEDENTES Y OBJETIVOS: La información recibida por los pacientes con EII sobre su enfermedad es de particular importancia. El objetivo de este estudio fue determinar los recursos informativos que utilizan estos pacientes, así como las lagunas de información que perciben y sus preferencias. PACIENTES Y MÉTODOS: Estudio prospectivo, observacional y transversal realizado en pacientes con EII atendidos en 13 hospitales españoles durante el año 2008. Los pacientes cumplimentaron un cuestionario semiestructurado de 52 preguntas. RESULTADOS: El cuestionario fue cumplimentado adecuadamente por 379 de los 385 pacientes participantes (98%). De ellos, el 57% presentaban enfermedad de Crohn y el 43% colitis ulcerosa. La edad media de los pacientes fue de 37,9 años (intervalo: 16-76 años). Los gastroenterólogos fueron el recurso más utilizado (98%), seguido de Internet (60%) y de los médicos de familia (50%). Más del 90% de los pacientes señaló un grado de satisfacción con el gastroenterólogo, el servicio de enfermería y las asociaciones de pacientes de buena a excelente. Solo el 56% considera que sus necesidades informativas están cubiertas. Los pacientes jóvenes y aquellos con un nivel educativo alto son los que más utilizan Internet. Al 85% de los pacientes le gustaría recibir información de los gastroenterólogos en el futuro, y el 92% preferiría tener entrevistas presenciales. Los pacientes quieren principalmente información adicional sobre tratamientos (médicos y quirúrgicos), manifestaciones clínicas, cáncer y riesgos de mortalidad. También piensan que están mal informados acerca de sus derechos sociales y laborales, los riesgos de cáncer y la mortalidad, así como sobre los estudios de investigación. CONCLUSIONES: Los pacientes con EII utilizan y prefieren tener a los gastroenterólogos como fuente principal de información, pero solo la mitad de ellos consideran que sus necesidades informativas están cubiertas

Information resources used by patients with inflammatory bowel disease: Satisfaction, expectations and information gaps.

BACKGROUND AND PURPOSE: Information received by IBD patients about their disease is of particular importance. The objective of the study was to determine the information resources these patients used, together with their perceived information gaps and expected preferences. PATIENTS AND METHODS: A prospective, observational, cross-sectional study conducted on IBD patients attending 13 Spanish hospitals during 2008. Patients completed a semi-structured 52-question survey. RESULTS: Survey was adequately completed by 379 of 385 patients (98%), of whom 57% had Crohn's disease and 43% ulcerative colitis. Mean patient age was 37.9 years (range, 16-76 years). Gastroenterologists were the most commonly used resource (98%), followed by the Internet (60%), and general practitioners (50%). More than 90% reported good to excellent satisfaction with gastroenterologists, nurses, and patients' associations. Only 56% considered their information needs to be covered. The Internet was mostly used by young patients and those with a high education level. In the future, 85% of the patients would like to receive information from the gastroenterologists, and 92% by face-to-face interviews. Patients mainly want additional information on treatment (medical and surgical), clinical manifestations, cancer, and mortality risks. They also think that they are poorly informed about their social and work rights, risks of cancer and death, and research trials. CONCLUSIONS: Patients with IBD use and prefer gastroenterologists as the main source of information, but only half of them consider their information needs to be covered.