Background: Crohn's disease (CD) can cause social and occupational limitations leading to substantial productivity losses. The aim of the study was to compare the social and occupational situation of CD patients with that of their not affected siblings or friends of youth who grew up in a similar socio-economic environment.
Background and aims: Crohn's disease (CD) and ulcerative colitis (UC) are lifelong inflammatory bowel diseases (IBD) progressing over time. Lack of public awareness may contribute to tardy consultation of primary care physicians, late diagnosis and development of potentially preventable complications of disease.
Summary Ulcerative colitis (UC) is one of the main forms of inflammatory bowel disease (IBD). Despite the widening range of drug treatment options, primary nonresponse, secondary loss of response as well as adverse events call for additional treatment alternatives. Tofacitinib is an oral small-molecule drug of the class of Janus kinase inhibitors which, in the European Union, was approved for the treatment of moderate to severe active UC in August 2018. This position paper, drawn up by the IBD Working Group of the Austrian Society of Gastroenterology and Hepatology, summarizes the mechanism of action, clinical development, marketing authorization status, efficacy and safety of tofacitinib. Also, by providing a synopsis of available data from both pivotal and post-marketing studies, clinical aspects of specific interest are highlighted and discussed. The available body of evidence indicates that tofacitinib is an additional effective medication for the treatment of UC that exhibits a good safety profile. This position paper aims at optimizing the safe and effective use of tofacitinib in daily clinical practice.
Abstract Background and Aims Standardising health outcome measurements supports delivery of care and enables data-driven learning systems and secondary data use for research. As part of the Health Outcomes Observatory [H2O] initiative, and building on existing knowledge, a core outcome set [COS] for inflammatory bowel diseases [IBD] was defined through an international modified Delphi method. Methods Stakeholders rated 90 variables on a 9-point importance scale twice, allowing score modification based on feedback displayed per stakeholder group. Two consecutive consensus meetings were held to discuss results and formulate recommendations for measurement in clinical practice. Variables scoring 7 or higher by ≥80% of the participants, or based on consensus meeting agreement, were included in the final set. Results In total, 136 stakeholders (45 IBD patients [advocates], 74 health care professionals/researchers, 13 industry representatives, and four regulators) from 20 different countries participated. The final set includes 18 case-mix variables, three biomarkers [haemoglobin to detect anaemia, C-reactive protein and faecal calprotectin to detect inflammation] for completeness, and 28 outcomes (including 16 patient-reported outcomes [PROs] and one patient-reported experience). The PRO-2 and IBD-Control questionnaires were recommended to collect disease-specific PROs at every contact with an IBD practitioner, and the Subjective Health Experience model questionnaire, PROMIS Global Health and Self-Efficacy short form, to collect generic PROs annually. Conclusions A COS for IBD, including a recommendation for use in clinical practice, was defined. Implementation of this set will start in Vienna, Berlin, Barcelona, Leuven, and Rotterdam, empowering patients to better manage their care. Additional centres will follow worldwide.
Zusammenfassung Biologika nehmen eine herausragende Rolle in der Therapie chronisch-entzündlicher Darmerkrankungen (CED) ein. Diese aus lebenden Zellen biotechnologisch hergestellten Antikörper (Ak) ermöglichen zunehmend selektive antientzündliche Behandlungsansätze, wobei deren Produktion und Zulassung einem komplexen und kostenintensiven Entwicklungsprozess unterliegen. Mit Patentablauf einzelner Biologika kommen seit einigen Jahren nun zunehmend Biosimilars, ebenso biotechnologisch produzierte Nachfolgepräparate, auf den Markt und führen zu einer zunehmenden Präparatevielfalt bei sinkenden Kosten für das Gesundheitssystems. Das vorliegende Positionspapier der Arbeitsgruppe (AG) CED der Österreichischen Gesellschaft für Gastroenterologie und Hepatologie (ÖGGH) versucht mit dieser Entwicklung aufkommende Fragen betreffend Wirksamkeit, Sicherheit, Präparatewechsel (Switch) und Verschreibungsgebarung zu beantworten, um eine höchstmögliche Patientensicherheit auch zukünftig zu gewährleisten.
