Sicherheit von Biologika bei rheumatoider Arthritis: Ergebnisse aus dem deutschen RABBIT-Register

Zusammenfassung

Hintergrund Das Biologika-Register RABBIT erfasst Krankheits- und Therapieverläufe von Patienten mit rheumatoider Arthritis (RA). Neben der Wirksamkeit von Biologika (bDMARDs: Originals und Biosimilars) und JAK-Inhibitor (JAKi) Therapien sind Daten zur Sicherheit, insbesondere in der Langzeittherapie, ein wesentlicher Bestandteil der Analysen aus RABBIT.

Methoden In das RABBIT-Register können Patienten mit einer gesicherten RA eingeschlossen werden, die nach mindestens einem konventionell synthetischen (cs)DMARD-Versagen eine neue cs-, bDMARD oder JAKi Therapie beginnen. Über 300 rheumatologische Einrichtungen schließen deutschlandweit Patienten in das Register ein. Einmal rekrutiert, werden die Patienten bis zu 10 Jahre lang beobachtet. Zu Beginn und im Verlauf werden Therapie, klinischer Status, Krankheitsverlauf und aufgetretene unerwünschte Ereignisse dokumentiert. In dieser Übersichtsarbeit werden relevante Ergebnisse aus dem RABBIT Register zur Sicherheit der bDMARDs bei RA zusammengefasst.

Ergebnisse Bis zum Frühjahr 2018 wurden über 17 000 RA Patienten in das RABBIT Register eingeschlossen. Die Daten aus 17 Beobachtungsjahren zeigen, dass das Risiko für schwerwiegende Infektionen unter bDMARDs erhöht ist. Das individuelle Risiko kann mit dem RABBIT Risiko Score abgeschätzt werden. Die Mortalität ist im Vergleich zu Patienten unter csDMARDs verringert. Auch das Risiko für das Auftreten einer Sepsis oder Versterben nach schwerwiegender Infektion ist unter bDMARDs erniedrigt. Hohe Krankheitsaktivität und eine unzureichende Behandlung kardiovaskulärer Komorbiditäten erhöhen das Risiko für das Auftreten kardiovaskulärer Ereignisse. Gemeinsame Auswertungen der Daten europäischer Biologika-Register zeigen kein erhöhtes Risiko für das Auftreten von Melanomen oder eine Verschiebung der Subtypen der Lymphome.

Fazit Insgesamt zeigen bDMARDs bei RA ein gutes Sicherheitsprofil. Kenntnis über die individuellen Risikofaktoren des Patienten, eine engmaschige Kontrolle der Krankheitsaktivität der RA und der Begleiterkrankungen sind wesentliche Faktoren, die das Auftreten von unerwünschten Ereignissen reduzieren können.

Abstract

Background The German RABBIT biologics register records the course of disease and therapy in patients with rheumatoid arthritis (RA). In addition to the effectiveness of biologics (bDMARDs), data on the safety of therapies, especially in long-term monitoring, are an essential part of the analyses from RABBIT.

Methods Patients with confirmed RA, who start a new conventional synthetic (cs) or bDMARD therapy after at least one csDMARD failure, can be included in the RABBIT register. More than 300 rheumatological units include patients in the register. Once enrolled, patients are monitored for up to 10 years. At baseline and follow-up visits, exact details on treatment, clinical status, course of disease and adverse events are documented. This review summarises relevant results from the RABBIT register on the safety of bDMARDs in RA.

Results By spring 2018, more than 17,000 RA patients were included in the RABBIT register. Data from 17 years of observation show that the risk of serious infections is increased in patients on bDMARDs. The individual risk can be approximated with the RABBIT Risk Score. Mortality is lower compared to patients on csDMARDs. Also the risk of sepsis and mortality after serious infection is reduced on bDMARDs. High disease activity and inadequate treatment of cardiovascular comorbidities increase the risk of cardiovascular events. Collaborative analyses of data from the European biologics registers reveal no increased risk of melanomas or a different distribution of lymphoma subtypes.

Conclusion All in all, bDMARDs have a good safety profile in patients with RA. Knowledge of a patient’s individual risk factors and continuous monitoring of the disease activity of RA and concomitant diseases are essential factors that can reduce the occurrence of adverse events.

Schlüsselwörter

Biologika - rheumatoide Arthritis - Arzneimittelsicherheit - Infektionen - kardiovaskuläre Ereignisse

Key words

Biologics - rheumatoid arthritis - drug safety - infections - cardiovascular events

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