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

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

来源：Neurology, 2016, 87(2): 134-140.

DOI：10.1212/WNL.0000000000002830

Objective: To provide new insights into the role of markers of response to interferon-beta 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-beta 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-beta indicates significant risk of treatment failure and EDSS worsening in the short term.

• 出版日期2016-7-12