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Sormani, MP; Gasperini, C; Romeo, M; Rio, J; Calabrese, M; Cocco, E; Enzinger, C; Fazekas, F; Filippi, M; Gallo, A; Kappos, L; Marrosu, MG; Martinelli, V; Prosperini, L; Rocca, MA; Rovira, A; Sprenger, T; Stromillo, ML; Tedeschi, G; Tintorè, M; Tortorella, C; Trojano, M; Montalban, X; Pozzilli, C; Comi, G; De Stefano, N; MAGNIMS study group.
Assessing response to interferon-β in a multicenter dataset of patients with MS.
Neurology. 2016; 87(2):134-140
Doi: 10.1212/WNL.0000000000002830
[OPEN ACCESS]
Web of Science
PubMed
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- Co-authors Med Uni Graz
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Enzinger Christian
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Fazekas Franz
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To provide new insights into the role of markers of response to interferon-β therapy in multiple sclerosis (MS) in a multicenter setting, focusing on the relevance of MRI lesions in combination with clinical variables.
A large multicenter clinical dataset was collected within the Magnetic Resonance Imaging in MS (MAGNIMS) network. This included a large cohort of patients with relapsing-remitting MS on interferon-β treatment, MRI and clinical assessments during the first year of treatment, and clinical follow-up of at least 2 additional years. Heterogeneity among centers was assessed before pooling the data. The association of 1-year MRI or clinical relapses with the risk of treatment failure (defined as Expanded Disability Status Scale [EDSS] worsening or treatment switch for inefficacy) and of EDSS worsening alone was evaluated using multivariate Cox models.
A pooled dataset of 1,280 patients with relapsing-remitting MS from 9 MAGNIMS centers was analyzed. The risk of failure had a relevant increase with 1 relapse (hazard ratio [HR] 1.84, 95% confidence interval [CI] 1.39-2.44, p < 0.001) and ≥3 new T2 lesions (HR 1.55, 95% CI 0.92-2.60, p = 0.09). In patients without relapses and less than 3 new T2 lesions, the 3-year risk of failure and EDSS worsening were 17% and 15%; in patients with 1 relapse or ≥3 new T2 lesions, the risks were 27% and 22%; in patients with both conditions or more than 1 relapse, the risks were 48% (p < 0.001) and 29% (p < 0.001).
Substantial MRI activity, particularly if in combination with clinical relapses, during the first year of treatment with interferon-β indicates significant risk of treatment failure and EDSS worsening in the short term.
© 2016 American Academy of Neurology.
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