Medicine (RMH) - Research Publications

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Author: Butzkueven, Helmut × Author: Jokubaitis, Vilija × Author: Kalincik, Tomas × Author: Kilpatrick, Trevor × Author: Spelman, Timothy × Start date: 2010 × Type: Journal Article ×

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    Persistence on therapy and propensity matched outcome comparison of two subcutaneous interferon beta 1a dosages for multiple sclerosis.
    Kalincik, T ; Spelman, T ; Trojano, M ; Duquette, P ; Izquierdo, G ; Grammond, P ; Lugaresi, A ; Hupperts, R ; Cristiano, E ; Van Pesch, V ; Grand'maison, F ; La Spitaleri, D ; Rio, ME ; Flechter, S ; Oreja-Guevara, C ; Giuliani, G ; Savino, A ; Amato, MP ; Petersen, T ; Fernandez-Bolanos, R ; Bergamaschi, R ; Iuliano, G ; Boz, C ; Lechner-Scott, J ; Deri, N ; Gray, O ; Verheul, F ; Fiol, M ; Barnett, M ; van Munster, E ; Santiago, V ; Moore, F ; Slee, M ; Saladino, ML ; Alroughani, R ; Shaw, C ; Kasa, K ; Petkovska-Boskova, T ; den Braber-Moerland, L ; Chapman, J ; Skromne, E ; Herbert, J ; Poehlau, D ; Needham, M ; Bacile, EAB ; Arruda, WO ; Paine, M ; Singhal, B ; Vucic, S ; Cabrera-Gomez, JA ; Butzkueven, H ; MSBase Study Group, ; Derfuss, T (Public Library of Science (PLoS), 2013)
    OBJECTIVES: To compare treatment persistence between two dosages of interferon β-1a in a large observational multiple sclerosis registry and assess disease outcomes of first line MS treatment at these dosages using propensity scoring to adjust for baseline imbalance in disease characteristics. METHODS: Treatment discontinuations were evaluated in all patients within the MSBase registry who commenced interferon β-1a SC thrice weekly (n = 4678). Furthermore, we assessed 2-year clinical outcomes in 1220 patients treated with interferon β-1a in either dosage (22 µg or 44 µg) as their first disease modifying agent, matched on propensity score calculated from pre-treatment demographic and clinical variables. A subgroup analysis was performed on 456 matched patients who also had baseline MRI variables recorded. RESULTS: Overall, 4054 treatment discontinuations were recorded in 3059 patients. The patients receiving the lower interferon dosage were more likely to discontinue treatment than those with the higher dosage (25% vs. 20% annual probability of discontinuation, respectively). This was seen in discontinuations with reasons recorded as "lack of efficacy" (3.3% vs. 1.7%), "scheduled stop" (2.2% vs. 1.3%) or without the reason recorded (16.7% vs. 13.3% annual discontinuation rate, 22 µg vs. 44 µg dosage, respectively). Propensity score was determined by treating centre and disability (score without MRI parameters) or centre, sex and number of contrast-enhancing lesions (score including MRI parameters). No differences in clinical outcomes at two years (relapse rate, time relapse-free and disability) were observed between the matched patients treated with either of the interferon dosages. CONCLUSIONS: Treatment discontinuations were more common in interferon β-1a 22 µg SC thrice weekly. However, 2-year clinical outcomes did not differ between patients receiving the different dosages, thus replicating in a registry dataset derived from "real-world" database the results of the pivotal randomised trial. Propensity score matching effectively minimised baseline covariate imbalance between two directly compared sub-populations from a large observational registry.