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Empfehlungen zur Therapie mit Interleukin-1β-blockierenden Wirkstoffen

Recommendations on therapy using interleukin-1β-blocking agents

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Zusammenfassung

Als Interleukin- (IL-)1β blockierender Wirkstoff steht in Deutschland bislang Anakinra (ANR) zur Verfügung (Stand: August 2009), das Erwachsenen in einer Dosierung von 100 mg/Tag, Kindern mit 1–2 mg/kg Körpergewicht/Tag (Tagesmaximaldosis 100 mg) subkutan verabreicht wird. Nach den vorliegenden, durch die Datenlage gestützten Erfahrungen empfiehlt die Deutsche Gesellschaft für Rheumatologie folgende Indikationen für ANR: 1. Rheumatoide Arthritis nach Versagen zweier über mindestens 6 Monate verabreichter konventioneller Basistherapeutika (DMARDs), eines davon Methotrexat (MTX). 2. Adulter Morbus Still sowie systemische juvenile idiopathische Arthritis („juveniler Morbus Still“) bei unzureichendem Ansprechen auf Glukokortikoide bzw. inadäquatem Dauerbedarf sowie Versagen eines konventionellen DMARD, in der Regel MTX. Bei beiden Indikationen muss die Mitbetreuung und Verlaufsdokumentation durch einen internistischen Rheumatologen bzw. Kinderrheumatologen gewährleistet sein. Als weitere Option für eine Behandlung mit ANR werden aufgrund der Datenlage die Cryopyrin-assoziierten periodischen Syndrome (CAPS) empfohlen.

Abgeschlossene Phase-III-Studien mit Wirkungsnachweis für CAPS liegen für das Fusionsprotein Rilonacept (RIL) sowie für den monoklonalen IL-1β-Antikörper Canakinumab vor. In den USA ist RIL unter dem „Orphan Drug Status“ für die Behandlung von CAPS zugelassen.

Abstract

In Germany, the only available interleukin-1β (IL-1β) blocking agent is anakinra (ANR) (as of August 2009) which is given subcutaneously at a dosage of 100 mg/day (adults) and 1–2 mg/kg body weight/day (maximum 100 mg/day) (children), respectively. Based on published data and clinical experience the German Society of Rheumatology (Deutsche Gesellschaft für Rheumatologie) recommends the following indications for ANR: (1) Rheumatoid arthritis, if treatment with two DMARDs (one of the two being methotrexate, MTX) for at least 6 months has failed. (2) Adult-onset and juvenile-onset Still’s disease (systemic juvenile idiopathic arthritis) in the case of insufficient response to glucocorticoids or inadequate long-term dosage, as well as failure of a conventional DMARD, usually MTX. For both indications the treatment should be supervised and documented by a rheumatologist or paediatric rheumatologist. Cryopyrin-associated periodic syndromes (CAPS) are recommended as an additional treatment option for IL-1 blocking therapy.

The efficacy of the fusion protein rilonacept (RIC) and the monoclonal antibody canakinumab in the treatment of CAPS has been proven by randomized, placebo-controlled trials. In the US, RIL was recently approved by the FDA for the treatment of CAPS under the “Orphan Drug Status”.

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Interessenkonflikt

Der korrespondierende Autor weist auf folgende Beziehungen hin: B.M. hat Vortrags- und Beratungshonorare der Fa. Novartis erhalten.

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  1. Medizinische Klinik III mit Poliklinik, FA Universität Erlangen-Nürnberg, Krankenhausstr. 12, 91054, Erlangen, Deutschland

    B. Manger

  2. Akademie für Manuelle Therapie , Münster, Deutschland

    M. Gaubitz

  3. Deutsches Zentrum für Kinder- und Jugendrheumatologie, Garmisch-Partenkirchen, Deutschland

    H. Michels

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Manger, B., Gaubitz, M., Michels, H. et al. Empfehlungen zur Therapie mit Interleukin-1β-blockierenden Wirkstoffen. Z. Rheumatol. 68, 766–771 (2009). https://doi.org/10.1007/s00393-009-0542-3

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