Zusammenfassung
Nach 6-jähriger klinischer Erfahrung in Deutschland gibt es für intramuskuläres Interferon-β-1a (Avonex®) inzwischen eine Fülle von Daten zu den diversen Stadien der multiplen Sklerose (MS). Dass unter 2-jähriger Behandlung mit diesem Medikament bei Patienten mit schubförmigem Verlauf die Wahrscheinlichkeit des Fortschreitens der Behinderungsprogression um 37 % vermindert werden kann, ging bereits 1996 aus der Zulassungsstudie von Jacobs u. Mitarb. hervor [1]. Neben den ermutigenden Resultaten dieser zulassungsrelevanten Phase-III-Studie überzeugen aber auch die jüngsten Ergebnisse der CHAMPS-Studie [2] zum frühzeitigen Therapiebeginn (Reduktion der Konversion zur klinisch manifesten multiplen Sklerose um 44 %) und die der IMPACT-Studie zum sekundär progredienten Verlauf (27 % Reduktion der Behinderungsprogression [MSFC]) [3]. In einer weiteren Studie - Dosisvergleich von 30 µg und 60 µg Avonex® i. m./Woche konnte eine Wirksamkeitssteigerung durch Dosisverdopplung nicht nachgewiesen werden. Alle zulassungsrelevanten Phase-III-Studien mit den in Deutschland erhältlichen Interferon-β-Präparaten zeigten vergleichbare Ergebnisse, jedoch eine bessere Verträglichkeit des einmal wöchentlich applizierten Interferon-β-1a (gemessen an der prozentualen Quote von Studienabbrechern aufgrund von Nebenwirkungen). Auch die Mehrzahl der bisher durchgeführten Vergleichsstudien bestätigt die vergleichbare Wirksamkeit der verschiedenen Interferon-β-Präparate. Lediglich zwei Vergleichsstudien von inzwischen zehn vorgestellten, deren Ergebnisse jedoch von denen der Zulassungsstudien abweichen, kommen zu anderen Ergebnissen.
Abstract
After six years of clinical experience in Germany there is a growing amount of data in the treatment with interferon β-1a Avonex® at different stages of multiple sclerosis. In the pivotal clinical trial of Jacobs et al. from 1996 a reduction on progression of disability of 37 % following a two year treatment with Avonex® was already shown [1]. Current data on early treatment from the CHAMPS study (44 % lower risk for the development of clinically definite MS) and the results from IMPACT in patients with secondary progressive MS (27 % reduction of progression in disability [MSFC]) are also encouraging [3]. Another study - a dose comparison of 30 µg and 60 µg Avonex® i. m. once a week - did not show any increase in clinical efficacy following treatment with the higher dose. All clinical phase-III-studies demonstrated comparable results for the three interferon beta preparations - which are approved in Germany - but demonstrated a better tolerability for Avonex® (measured by the percental rate of drop-outs due to side-effects). Also, the majority of available comparative trials suggest comparable efficacy for the different interferon beta substances. Only two of currently ten presented comparator trials, which differ from the pivotal phase-III-trials, come to different results.
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Priv.-Doz. Dr. med. Volker Limmroth
Klinik und Poliklinik für Neurologie
Hufelandstraße 55
45147 Essen
