Zusammenfassung
Insbesondere für klinische Studien, aber auch für den Praxisalltag, sind Parameter oder Messinstrumente erforderlich, anhand derer der unmittelbare Behandlungserfolg, die Krankheitsaktivität und ggf. auch der weitere Krankheitsverlauf einer Erkrankung beurteilt werden können, so genannte „Outcome“-Parameter. Solche Kriterien können auch helfen, Risikogruppen von Patienten zu definieren, die einer besonderen Kontrolle bzw. Therapie bedürfen. Sie sollten möglichst zuverlässig, objektiv und valide sein, z. B. um eine gute Vergleichbarkeit von Studienergebnissen zu gewährleisten. Outcome-Parameter sind daher gezielt für das jeweilige Krankheitsbild bzw. die jeweilige Fragestellung zu entwickeln und/oder neu zu validieren. Für das Sjögren-Syndrom, eine häufige, systemische Autoimmunerkrankung unklarer Genese, existieren bislang nur begrenzte therapeutische Möglichkeiten. Vor dem Hintergrund zu erwartender neuer Therapieansätze gibt der vorliegende Artikel einen kritischen Überblick über die verfügbaren bzw. in Entwicklung befindlichen möglichen Outcome-Parameter für Sjögren-Patienten.
Abstract
Not only in the context of clinical trials in particular, but also in daily clinical practice, outcome parameters or measuring instruments are essential to assess the efficacy of a therapeutic intervention, its influence on disease activity and potentially also to predict further disease course. Such criteria can assist in the identification of patient risk groups that may require special checkups or interventions. Moreover, these parameters should be reliable, objective and valid, e.g. to allow comparison of results from different studies. Therefore, outcome parameters need to be developed and/or validated in a targeted manner for individual diseases or investigations. To date, we have only limited therapeutic options for Sjögren’s syndrome, a frequent systemic autoimmune disorder of unknown origin. Against the background of the new therapy approaches expected, this article provides a critical overview of available and newly developed outcome parameters for patients with Sjögren’s syndrome.
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Interessenkonflikt
Der korrespondierende Autor weist auf folgende Beziehung hin: E. Feist hat Vortragshonorare durch die Fa. Roche Pharma AG Deutschland erhalten.
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Feist, E., Hansen, A. Kritischer Überblick zu Outcome-Parametern bei Patienten mit primärem Sjögren-Syndrom. Z. Rheumatol. 69, 25–31 (2010). https://doi.org/10.1007/s00393-009-0516-5
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DOI: https://doi.org/10.1007/s00393-009-0516-5