Assessing response to interferon-β in a multicenter dataset of patients with MS

Maria Pia Sormani, Claudio Gasperini, Marzia Romeo, Jordi Rio, Massimiliano Calabrese, Eleonora Cocco, Christian Enzingher, Franz Fazekas, Massimo Filippi, Antonio Gallo, Ludwig Kappos, Maria Giovanna Marrosu, Vittorio Martinelli, Luca Prosperini, Maria Assunta Rocca, Alex Rovira, Till Sprenger, Maria Laura Stromillo, Gioacchino Tedeschi, Mar TintorèCarla Tortorella, Maria Trojano, Xavier Montalban, Carlo Pozzilli, Giancarlo Comi, Nicola De Stefano

Research output: Contribution to journalArticlepeer-review

104 Scopus citations


Objective: 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. Methods: 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. Results: 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). Conclusions: 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.

Original languageEnglish
Pages (from-to)134-140
Number of pages7
Issue number2
StatePublished - 12 Jul 2016
Externally publishedYes


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