Sicherheit und Wirksamkeit der Therapie der rheumatoiden Arthritis im Alter: Was sagen Register- und Routinedaten?

Zusammenfassung

Ältere Menschen werden aufgrund von chronischen Erkrankungen, den notwendigen medikamentösen Therapien oder allein wegen ihres Alters oftmals aus randomisierten klinischen Studien ausgeschlossen. Wenn neue Arzneimittel zugelassen werden, wissen wir daher wenig über ihre Sicherheit und Wirksamkeit im Alter. Diese Lücke können Beobachtungsdaten aus der klinischen Praxis schließen. Register und Beobachtungsstudien zeigen, dass ältere Menschen mit rheumatoider Arthritis (RA) zurückhaltender behandelt werden als jüngere. Dies kann dazu führen, dass die Kontrolle der Krankheitsaktivität der RA weniger gut gelingt und vermeidbare Risiken, z. B. durch Glukokortikoide, entstehen. In Bezug auf die Wirksamkeit zielgerichteter Therapien wurden in Beobachtungsstudien meist keine relevanten Unterschiede zwischen jüngeren und älteren Patient:innen festgestellt. Auch die Kontinuität der b/tsDMARD-Therapie ist bei älteren und jüngeren Patient:innen vergleichbar. Bei der Bewertung der Therapiesicherheit ist zu berücksichtigen, dass bei älteren Patient:innen vermehrt unerwünschte Ereignisse auftreten, die nur teilweise den Therapien zugerechnet werden können. Die großen Beobachtungsregister ermöglichen es, Gruppen von Älteren unter verschiedenen Expositionen zu vergleichen. Dieser Beitrag gibt eine Übersicht über die Häufigkeiten schwerwiegender Ereignisse im Alter, insbesondere die Risiken von Infektionen, Malignomen, gastrointestinalen Perforationen und kardiovaskulären Ereignissen.

Abstract

Summary Elderly people are often excluded from randomised clinical trials due to chronic diseases, required drug therapies, or merely due to their age. When new drugs are approved, we therefore have little knowledge of their safety and efficacy in old age. This gap can be closed by observational real-world data. Registries and observational studies show that older people with rheumatoid arthritis (RA) are treated more cautiously than younger people with a view to the fact that they often already receive extensive pharmacotherapy. This can lead to a less successful control of RA disease activity and avoidable risks, e. g. from glucocorticoids. With regard to the effectiveness of targeted therapies, observational studies have revealed no relevant differences between younger and older patients. Drug survival of b/tsDMARD therapy is also comparable between older and younger patients. When assessing treatment safety, it should be borne in mind that older patients are more likely to experience adverse events that can be only partially attributed to the therapies. Thanks to large observational registries, groups of older people can be compared under different exposures. This article provides an overview of the frequency of serious events in patients of older age, in particular the risks of infections, malignancies, gastrointestinal perforations, and cardiovascular events.

Schlüsselwörter

DMARDs - Glukokortikoide - Infektionen - Malignome - Nutzen-Risiko-Verhältnis

Keywords

DMARDs - glucocorticoids - infections - malignancies - benefit/risk ratio

Publication History

Article published online:
27 August 2024

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