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Published on: December 9, 2015
Assessing response to interferon-β in a multicenter dataset of patients with MS
Maria Pia Sormani1, Claudio Gasperini2, Marzia Romeo2
1From the University of Genoa (M.P.S.); Hospital San Camillo Forlanini (C.G.) and Department of Neurology and Psychiatry (L.P., C.P.), Sapienza University, Rome; Department of Neurology (M.R., V.M., G.C.) and Neuroimaging Research Unit (M.A.R., M.F.), San Raffaele Scientific Institute, Milan, Italy; Hospital Universitario Vall d'Hebron (J.R., M. Tintorè, A.R., X.M.), Barcelona, Spain; University of Verona (M.C.); Department of Public Health, Clinical and Molecular Medicine (E.C.), and Department of Medical Sciences (M.G.M., E.C.), University of Cagliari, Italy; Department of Neurology (C.E., F.F.), Medical University of Graz, Austria; Dip. to di Scienze Mediche, Chirurgiche, Neurologiche, Metaboliche e dell'Invecchiamento (A.G., G.T.), Seconda Universita' di Napoli, MRI Research Center "SUN-FISM," Hermitage-Capodimonte Clinic, Naples, Italy; Neurology (L.K., T.S.), Departments of Medicine, Clinical Research, and Biomedical Engineering, University Hospital Basel, Switzerland; DKD Helios Klinik Wiesbaden (T.S.), Germany; University of Siena (M.L.S., N.D.S.); and Department of Medical Sciences, Neurosciences and Sense Organs (M. Trojano, C.T.), University of Bari, Italy. mariapia.sormani@unige.it.
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.
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