Persistence on Therapy and Propensity Matched Outcome Comparison of Two Subcutaneous Interferon Beta 1a Dosages for Multiple Sclerosis

Tomas Kalincik, T Spelman, M Trojano, P Duquette, G Izquierdo, P Grammond, A Lugaresi, R Hupperts, E Cristiano, V Van Pesch, F Grand'Maison, Daniele La Spitaleri, M Rio, S Flechter, C Oreja-Guevara, G Giuliani, A Savino, M Amato, T Petersen, R Fernandez-BolanosR Bergamaschi, G Iuliano, C Boz, Jeannette Lechner-Scott, N Deri, O Gray, F Verheul, M Fiol, Michael Barnett, Erik van Munster, V Santiago, F Moore, Mark Slee, M Saladino, Raed Alroughani, C Shaw, Krisztian Kasa, T Petkovska-Boskova, Leontien den Braber-Moerland, Joab Chapman, Eli Skromne, Joseph Herbert, D Poehlau, Merilee Needham, E Bacile, W Oleschko Arruda, Mark Paine, Bhim Singhal, Steve Vucic, J Cabrera-Gomez, H Butzkueven

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    21 Citations (Scopus)

    Abstract

    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 mg vs. 44 mg 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 "-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.

    Original languageEnglish
    Article numbere63480
    Pages (from-to)e63480
    Number of pages9
    JournalPLoS One
    Volume8
    Issue number5
    DOIs
    Publication statusPublished - 21 May 2013

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    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, M., Flechter, S., Oreja-Guevara, C., Giuliani, G., Savino, A., Amato, M., Petersen, T., ... Butzkueven, H. (2013). Persistence on Therapy and Propensity Matched Outcome Comparison of Two Subcutaneous Interferon Beta 1a Dosages for Multiple Sclerosis. PLoS One, 8(5), e63480. [e63480]. https://doi.org/10.1371/journal.pone.0063480