TY - JOUR
T1 - Comparative effectiveness of glatiramer acetate and interferon beta formulations in relapsing – remitting multiple sclerosis
AU - Kalincik, Tomas
AU - Jokubaitis, Vilija
AU - Izquierdo, Guillermo
AU - Duquette, Pierre
AU - Girard, Marc
AU - Grammond, Pierre
AU - Lugaresi, Alessandra
AU - Oreja-Guevara, Celia
AU - Bergamaschi, Robert
AU - Hupperts, Raymond
AU - Grand'Maison, Francois
AU - Pucci, Eugenio
AU - Van Pesch, Vincent
AU - Boz, Cavit
AU - Iuliano, Gerardo
AU - Fernandez-Bolanos, Ricardo
AU - Fletcher, Shlomo
AU - La Spitaleri, Daniele
AU - Cristiano, Edgardo
AU - Verheul, Freek
AU - Lechner-Scott, Jeannette
AU - Amato, M
AU - Cabrera-Gomez, Jose
AU - Saladino, Maria
AU - Slee, Mark
AU - Moore, Fraser
AU - Gray, Orla
AU - Paine, Mark
AU - Barnett, Michael
AU - Havrdova, Eva
AU - Horakova, Dana
AU - Spelman, Timothy
AU - Trojano, Maria
AU - Butzkueven, Helmut
PY - 2015/8/25
Y1 - 2015/8/25
N2 - Background: The results of head-to-head comparisons of injectable immunomodulators (interferon β, glatiramer acetate) have been inconclusive and a comprehensive analysis of their effectiveness is needed. Objective: We aimed to compare, in a real-world setting, relapse and disability outcomes among patientswith multiple sclerosis (MS) treated with injectable immunomodulators. Methods: Pairwise analysis of the international MSBase registry data was conducted using propensityscore matching. The four injectable immunomodulators were compared in six head-to-head analyses of relapse and disability outcomes using paired mixed models or frailty proportional hazards models adjusted for magnetic resonance imaging variables. Sensitivity and power analyses were conducted. Results: Of the 3326 included patients, 3451199 patients per therapy were matched (median pairwisecensored follow-up was 3.7 years). Propensity matching eliminated >95% of the identified indication bias. Slightly lower relapse incidence was found among patients treated with glatiramer acetate or subcutaneous interferon β-1a relative to intramuscular interferon β-1a and interferon β-1b (-rfpag≤0.001). No differences in 12-month confirmed progression of disability were observed. Conclusion: Small but statistically significant differences in relapse outcomes exist among the injectable immunomodulators. MSBase is sufficiently powered to identify these differences and reflects practice in tertiary MS centres. While the present study controlled indication, selection and attrition bias, centredependent variance in data quality was likely.
AB - Background: The results of head-to-head comparisons of injectable immunomodulators (interferon β, glatiramer acetate) have been inconclusive and a comprehensive analysis of their effectiveness is needed. Objective: We aimed to compare, in a real-world setting, relapse and disability outcomes among patientswith multiple sclerosis (MS) treated with injectable immunomodulators. Methods: Pairwise analysis of the international MSBase registry data was conducted using propensityscore matching. The four injectable immunomodulators were compared in six head-to-head analyses of relapse and disability outcomes using paired mixed models or frailty proportional hazards models adjusted for magnetic resonance imaging variables. Sensitivity and power analyses were conducted. Results: Of the 3326 included patients, 3451199 patients per therapy were matched (median pairwisecensored follow-up was 3.7 years). Propensity matching eliminated >95% of the identified indication bias. Slightly lower relapse incidence was found among patients treated with glatiramer acetate or subcutaneous interferon β-1a relative to intramuscular interferon β-1a and interferon β-1b (-rfpag≤0.001). No differences in 12-month confirmed progression of disability were observed. Conclusion: Small but statistically significant differences in relapse outcomes exist among the injectable immunomodulators. MSBase is sufficiently powered to identify these differences and reflects practice in tertiary MS centres. While the present study controlled indication, selection and attrition bias, centredependent variance in data quality was likely.
KW - disability
KW - Multiple sclerosis
KW - patient registry
KW - propensity score
KW - real-world date
KW - Relapses
KW - treatment outcomes
UR - http://www.scopus.com/inward/record.url?scp=84985916687&partnerID=8YFLogxK
U2 - 10.1177/1352458514559865
DO - 10.1177/1352458514559865
M3 - Article
VL - 21
SP - 1159
EP - 1171
JO - Multiple Sclerosis
JF - Multiple Sclerosis
SN - 1352-4585
IS - 9
ER -