QUASIMS: eine deutschlandweite Beobachtungsstudie der Interferon-Beta-Präparate zur Therapie der schubförmigen multiplen Sklerose

Zusammenfassung

Interferon-beta(IFNβ)-Präparate sind die am häufigsten eingesetzte Therapie in der Behandlung der schubförmigen multiplen Sklerose (MS). Die Quality Assessment in MS Therapy (QUASIMS) Studie ist eine große, offene Beobachtungsstudie zum Vergleich der Wirksamkeit und Verträglichkeit aller zur Verfügung stehenden IFNb-Präparate in der Therapie der schubförmigen MS. In diese retrospektive Kohortenstudie wurden an 255 Schwerpunktzentren in Deutschland alle Patienten eingeschlossen, die mindestens 2 Jahre kontinuierlich mit IFNβ1a 30 µg 1-mal/Woche i. m. (Avonex®), IFNβ1b 250 µg s. c. jeden 2. Tag (Betaferon®) oder IFNβ1a 22 µg oder 44 µg 3-mal/Woche s. c. (Rebif®) behandelt wurden. Die vordefinierten Endpunkte waren Änderung des EDSS, Anteil progressionsfreier Patienten (< 1 EDSS-Punkt), jährliche Schubrate, Anteil schubfreier Patienten und Gründe für einen Therapiewechsel. Von 4475 eingeschlossenen Patienten erhielten 3836 (85,7 %) IFNβ als Initialtherapie (zuvor unbehandelt). Es gab keine signifikanten Unterschiede in der Wirksamkeit zwischen den IFNβ-Präparaten in der Initialtherapie und der Folgetherapie (nach einer Therapieumstellung) bei den meisten Endpunkten. Die Schubrate in der Folgetherapie war tendenziell höher und der Anteil schubfreier Patienten niedriger. QUASIMS enthält Daten für 30 % aller Patienten, die 2 Jahre in Deutschland mit IFNβ behandelt wurden und zeigt eine vergleichbare Wirksamkeit der IFNβ-Präparate. Ein Wechsel von einem IFNβ auf ein anderes scheint die Wirksamkeit nicht erhöhen zu können.

Abstract

Interferon beta (IFNβ) preparations are the most frequently prescribed therapies for patients with relapsing multiple sclerosis (MS). Several open-label observational studies report similar efficacy among IFNβ preparations. The Quality Assessment in Multiple Sclerosis Therapy (QUASIMS) study is a large, open-label observational study designed to compare the effectiveness and tolerability of available IFNβ preparations as disease-modifying therapies for relapsing MS across a wide range of clinical practice settings. This retrospective, controlled cohort study was conducted by chart review at 255 sites in Germany. Enrolled patients had received one of the four available IFNβ preparations/dosing regimens (intramuscular IFNβ-1a 30 µg 1 ×/week [Avonex®], subcutaneous [SC] IFNβ-1a 22 or 44 µg 3 ×/week [Rebif®], or SC IFNβ-1b 250 µg 3,5 ×/week [Betaferon®]) for ≥ 2 years. Preplanned outcomes at 1 and 2 years included change from baseline Expanded Disability Status Scale (EDSS) score, percentage of progression-free patients, annualised relapse rate (RR), percentage of relapse-free patients, and reasons for therapy change. Of 4475 evaluable patients, 3836 (84.7 %) received IFNβ as initial therapy. There were no significant differences among IFNβs when used as initial or follow-up therapy on most outcome variables. Relapse rate was consistently higher and percentage of relapse-free patients consistently lower when IFNβ was used as follow-up versus initial therapy. Results of QUASIMS reveal similar effectiveness among IFNβ products. Benefits were consistently higher when IFNβ was used as initial rather than follow-up therapy. Our results suggest that patients do not benefit in terms of disease outcome from switching between IFNβ preparations/dosing regimens.

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