3.6 BEYOND-Studie
250 μg or 500 μg interferon beta-1b versus 20 mg glatiramer acetate in relapsing-remitting multiple sclerosis: a prospective, randomised, multicentre study
2008
Auszug aus der Publikation von O‘Connor P et al., 2009
Summary
Background: The aim of the Betaferon Efficacy Yielding Outcomes of a New Dose (BEYOND) trial was to compare the efficacy, safety, and tolerability of 250 μg or 500 μg interferon beta-1b with glatiramer acetate for treating relapsing-remitting multiple sclerosis.
Methods: Between November, 2003, and June, 2005, 2447 patients with relapsing remitting multiple sclerosis were screened and 2244 patients were enrolled in this prospective, multicentre, randomised trial. Patients were randomly assigned 2:2:1 by block randomisation with regional stratification to receive one of two doses of interferon beta-1b (250 μg or 500 μg) subcutaneously every other day or 20 mg glatiramer acetate subcutaneously every day. The primary outcome was relapse risk, defined as new or recurrent neurological symptoms separated by at least 30 days from the preceding event and that lasted at least 24 h. Secondary outcomes were progression on the expanded disability status scale (EDSS) and change in T1-hypointense lesion volume. Clinical outcomes were assessed quarterly for 2.0 – 3.5 years; MRI was done at screening and annually thereafter. Analysis was by per protocol. This study is registered, number NCT00099502.
Findings: We found no differences in relapse risk, EDSS progression, T1-hypo- intense lesion volume, or normalised brain volume among treatment groups. Flu-like symptoms were more common in patients treated with interferon beta-1b (p<0,0001), whereas injection-site reactions were more common in patients treated with glatiramer acetate (p=0,0005). Patient attrition rates were 17% (153 of 888) on 250 μg interferon beta-1b, 26% (227 of 887) on 500 μg interferon beta-1b, and 21% (93 of 445) for glatiramer acetate.
Interpretation: 500 μg interferon beta-1b was not more effective than the standard 250 μg dose, and both doses had similar clinical effects to glatiramer acetate. Although interferon beta-1b and glatiramer acetate had different adverse event profiles, the overall tolerability to both drugs was similar.
O‘Connor P et al., The Lancet Neurology 2009;8(10):889–892
Studienziel:
- Vergleich der Wirksamkeit, Sicherheit und Verträglichkeit von Betaferon 250 μg, Interferon beta-1b 500 μg und Glatirameracetat bei Patienten mit schubförmig-remittierender MS
Primäre Endpunkte:
- Schubrisiko
Sekundäre Endpunkte:
- EDSS-Progression
- Änderung des T1-Läsionsvolumens
Unterstützende schubbezogene Endpunkte:
- Jährliche Schubrate
- Tage bis zum ersten Schub im zweiten Jahr
- Anteil schubfreier Patienten
Studienergebnisse:
- Vergleichbares Schubrisiko unter Betaferon und Glatirameracetat.
- Betaferon 250 µg kann die Schubrate im Vergleich zum Zeitraum vor Therapiebeginn signifikant um ca 80% senken. (s. Abb. 28)
- Signifikante Vorteile unter Betaferon gegenüber Glatirameracetat hinsichtlich der T2-Läsionslast und des Volumens Gd-anreichernder Läsionen.
- Signifikant weniger Injektionsreaktionen unter Betaferon 250 μg als unter Glatirameracetat. Häufigeres Auftreten von Grippesymptomen und erhöhten Leberwerten unter Betaferon als unter Glatirameracetat
