Selektive Modulation der T-Zell-Kostimulation: Sicherheit und Verträglichkeit von Abatacept in der Langzeitanwendung

Zusammenfassung

Biologika haben die Behandlungsmöglichkeiten bei rheumatoider Arthritis (RA) deutlich bereichert. Da diese Therapien potenziell über viele Jahre angewendet werden, sind Erfahrungen zu ihrer langfristigen Sicherheit und Verträglichkeit von besonderer Bedeutung. Für den selektiven T-Zell-Kostimulations-Modulator Abatacept liegen aus Extensionsstudien von randomisierten kontrollierten Studien der Phasen IIb und III Daten vor, welche die Sicherheit und Verträglichkeit der Substanz für einen Zeitraum von bis zu 7 Jahren dokumentieren. Diese Studien ergaben, dass in der Langzeitanwendung vs. einer 6- oder 12-monatigen Behandlung kein Anstieg der Inzidenzen von Infektionen, schwerwiegenden Infektionen und Malignitäten resultiert. Allgemein zeigten sich unter der Therapie eine gering erhöhte Rate schwerwiegender Infektionen im Vergleich zu Plazebo sowie eine geringere oder vergleichbare Häufigkeit schwerwiegender Infektionen im Vergleich zu anderen Biologika. Opportunistische Infektionen wurden im Zusammenhang mit der Gabe von Abatacept selten beobachtet. Das Malignomrisiko entsprach in den bisherigen Untersuchungen dem Risiko, das in einer alters- und geschlechtsangepassten Gruppe der RA-Patienten zu erwarten ist.

Abstract

Biologicals have significantly improved the treatment options for patients with rheumatoid arthritis (RA). Since RA patients use these therapies potentially over many years, long-time experience about their safety and tolerability is of particular importance. Abatacept, the first drug in the new class of selective co-stimulation modulators, has been investigated in several randomised clinical trials (phase IIb and III) with a cumulative follow-up period of up to 7 years. Thereby it was shown that the risk for infections, severe infections and malignancies did not increase with the long-term use of abatacept as compared to a 6- to 12-month use. In general, the trials indicated that severe infections were more common in abatacept-treated patients compared to placebo-treated patients, but the incidence of severe infections was lower or comparable to that of patient groups treated with other biological DMARDs. There were rare reports of opportunistic infections in patients treated with abatacept and the incidence of malignancies did not exceed the expected rate in the group of RA patients.

Schlüsselwörter

rheumatoide Arthritis - Biologika - Abatacept - Sicherheit und Verträglichkeit im Langzeitverlauf

Key words

rheumatoid arthritis - biological therapies - abatacept - safety and tolerability in long-term use

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