TY - JOUR
T1 - Persistence on therapy and propensity matched outcome comparison of two subcutaneous interferon beta 1a dosages for multiple sclerosis
AU - Kalincik, Tomas
AU - Spelman, Timothy
AU - Trojano, Maria
AU - Duquette, Pierre
AU - Izquierdo, Guillermo
AU - Grammond, Pierre
AU - Lugaresi, Alessandra
AU - Hupperts, Raymond
AU - Cristiano, Edgardo
AU - Van Pesch, Vincent
AU - Grand'Maison, Francois
AU - La Spitaleri, Daniele
AU - Rio, Maria Edite
AU - Flechter, Sholmo
AU - Oreja-Guevara, Celia
AU - Giuliani, Giorgio
AU - Savino, Aldo
AU - Amato, Maria Pia
AU - Petersen, Thor
AU - Fernandez-Bolanos, Ricardo
AU - Bergamaschi, Roberto
AU - Iuliano, Gerardo
AU - Boz, Cavit
AU - Lechner-Scott, Jeannette
AU - Deri, Norma
AU - Gray, Orla
AU - Verheul, Freek
AU - Fiol, Marcela
AU - Barnett, Michael
AU - Van Munster, Erik
AU - Santiago, Vetere
AU - Moore, Fraser
AU - Slee, Mark
AU - Saladino, Maria Laura
AU - Alroughani, Raed
AU - Shaw, Cameron
AU - Kasa, Krisztian
AU - Petkovska-Boskova, Tatjana
AU - Den Braber-Moerland, Leontien
AU - Chapman, Joab
AU - Skromne, Eli
AU - Herbert, Joseph
AU - Poehlau, Dieter
AU - Needham, Merrilee
AU - Bacile, Elizabeth Alejandra Bacile
AU - Arruda, Walter Oleschko
AU - Paine, Mark
AU - Singhal, Bhim
AU - Vucic, Steve
AU - Cabrera-Gomez, Jose Antonio
AU - Butzkueven, Helmut
PY - 2013/5/21
Y1 - 2013/5/21
N2 - 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.
AB - 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.
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U2 - 10.1371/journal.pone.0063480
DO - 10.1371/journal.pone.0063480
M3 - Article
C2 - 23704913
AN - SCOPUS:84891613722
VL - 8
JO - PLoS One
JF - PLoS One
SN - 1932-6203
IS - 5
M1 - e63480
ER -