Medicine (RMH) - Research Publications

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Author: Butzkueven, Helmut × Author: Jokubaitis, Vilija × Author: Liew, Danny × Author: Spelman, Timothy ×

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    Predictors of disability worsening in clinically isolated syndrome
    Jokubaitis, VG ; Spelman, T ; Kalincik, T ; Izquierdo, G ; Grand'Maison, F ; Duquette, P ; Girard, M ; Lugaresi, A ; Grammond, P ; Hupperts, R ; Cabrera-Gomez, J ; Oreja-Guevara, C ; Boz, C ; Giuliani, G ; Fernandez-Bolanos, R ; Iuliano, G ; Lechner-Scott, J ; Verheul, F ; van Pesch, V ; Petkovska-Boskova, T ; Fiol, M ; Moore, F ; Cristiano, E ; Alroughani, R ; Bergamaschi, R ; Barnett, M ; Slee, M ; Vella, N ; Herbert, J ; Shaw, C ; Saladino, ML ; Amato, MP ; Liew, D ; Paolicelli, D ; Butzkueven, H ; Trojano, M (WILEY-BLACKWELL, 2015-05)
    OBJECTIVE: To assess demographic, clinical, magnetic resonance imaging, and treatment exposure predictors of time to 3 or 12-month confirmed disability worsening in clinically isolated syndrome (CIS) and early multiple sclerosis (MS). METHODS: We utilized the MSBase Incident Study (MSBasis), a prospective cohort study of outcome after CIS. Predictors of time to first 3 and 12-month confirmed expanded disability status scale worsening were analyzed using Cox proportional hazards regression. RESULTS: About 1989 patients were analyzed, the largest seen-from-onset cohort reported to-date. A total of 391 patients had a first 3-month confirmed disability worsening event, of which 307 were sustained for 12 months. Older age at CIS onset (adjusted hazard ratio: aHR 1.17, 95% 1.06, 1.30), pyramidal (aHR 1.45, 95% CI 1.13, 1.89) and ambulation (HR 1.60, 95% CI 1.09, 2.34) system dysfunction, annualized relapse rate (aHR 1.20, 95% CI 1.18, 1.22), and lower proportion of observation time on treatment were associated with 3-month confirmed worsening. Predictors of time to 12-month sustained worsening included pyramidal system dysfunction (Hazard ratio: aHR 1.38, 95% CI 1.05, 1.83), and older age at CIS onset (aHR 1.17, 95% CI 1.04, 1.31). Greater proportion of follow-up time exposed to treatment was associated with greater reductions in the rate of worsening. INTERPRETATION: This study provides class IV evidence for a strong protective effect of disease-modifying treatment to reduce disability worsening events in patients with CIS and early MS, and confirms age and pyramidal dysfunction at onset as risk factors.
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    The Australian Multiple Sclerosis (MS) Immunotherapy Study: A Prospective, Multicentre Study of Drug Utilisation Using the MSBase Platform
    Jokubaitis, VG ; Spelman, T ; Lechner-Scott, J ; Barnett, M ; Shaw, C ; Vucic, S ; Liew, D ; Butzkueven, H ; Slee, M ; Oreja-Guevara, C (PUBLIC LIBRARY SCIENCE, 2013-03-19)
    OBJECTIVE: To prospectively characterise treatment persistence and predictors of treatment discontinuation in an Australian relapsing-remitting multiple sclerosis (RRMS) population. METHODS: Tertiary MS treatment centres participating in the MSBase registry prospectively assessed treatment utilisation, persistence, predictors of treatment discontinuation and switch rates. Multivariable survival analyses were used to compare treatment persistence between drugs and to identify predictors of treatment discontinuation. RESULTS: 1113 RRMS patients were studied. Patients persisted on their first disease-modifying therapy (DMT) for a median of 2.5 years. Treatment persistence on GA was shorter than on all IFNβ products (p<0.03). Younger age at treatment initiation and higher EDSS were predictive of DMT discontinuation. Patients persisted on subsequent DMTs, for 2.3 years. Patients receiving natalizumab (NAT) as a subsequent DMT persisted longer on treatment than those on IFNβ or GA (p<0.000). The primary reason for treatment discontinuation for any drug class was poor tolerability. Annualised switch or cessation rates were 9.5-12.5% for individual IFNβ products, 11.6% for GA and 4.4% for NAT. CONCLUSION: This multicentre MS cohort study is the first to directly compare treatment persistence on IFNβ and GA to NAT. We report that treatment persistence in our Australian RRMS population is short, although patients receiving IFNβ as a first DMT persisted longer on treatment than those on GA. Additionally, patients receiving NAT as a subsequent DMT were more likely to persist on treatment than those switched to IFNβ or GA. EDSS and age at DMT initiation were predictive of DMT discontinuation. Treatment intolerance was the principal reason for treatment cessation.