Changes in magnetic resonance imaging disease measures over 3 years in mildly disabled patients with relapsing-remitting multiple sclerosis receiving interferon β-1a in the COGnitive Impairment in MUltiple Sclerosis (COGIMUS) study
1 National Neurological Institute, C Mondino Foundation, IRCCS, Via Ferrata, I-27100, Pavia, Italy
2 European Biomedical Foundation Onlus, via Nizza 53, 00198, Rome, Italy
3 Department of Neurology, University of Florence, Viale Morgagni 85, 50134 Florence, Italy
4 Department of Neuroscience and Rehabilitation, Azienda Università-Ospedale, Corso Giovecca 203, 44100 Ferrara, Italy
5 Department of Neurological and Psychiatric Sciences, University of Bari, Piazza Giulio Cesare, 70124 Bari, Italy
6 European Biomedical Foundation, Onlus, Rome, Italy
7 IRCCS Foundazione Santa Lucia, Via Ardeatina 306, 00179 Rome, Italy
8 Biostructure and Bioimaging Institute, National Research Council, Via Pansini 5, 80131 Naples, Italy
9 Opera S.r.l., Via Sampierdarena 33, 16149 Genova, Italy
10 Department of Neurology, Multiple Sclerosis Centre Sicilia Region, First Neurology Clinic, University Hospital, Via Santa Sofia 78, 95123 Catania, Italy
BMC Neurology 2011, 11:125 doi:10.1186/1471-2377-11-125Published: 14 October 2011
Conventional magnetic resonance imaging (MRI) has improved the diagnosis and monitoring of multiple sclerosis (MS). In clinical trials, MRI has been found to detect treatment effects with greater sensitivity than clinical measures; however, clinical and MRI outcomes tend to correlate poorly.
In this observational study, patients (n = 550; 18-50 years; relapsing-remitting MS [Expanded Disability Status Scale score ≤4.0]) receiving interferon (IFN) β-1a therapy (44 or 22 µg subcutaneously [sc] three times weekly [tiw]) underwent standardized MRI, neuropsychological and quality-of-life (QoL) assessments over 3 years. In this post hoc analysis, MRI outcomes and correlations between MRI parameters and clinical and functional outcomes were analysed.
MRI data over 3 years were available for 164 patients. T2 lesion and T1 gadolinium-enhancing (Gd+) lesion volumes, but not black hole (BH) volumes, decreased significantly from baseline to Year 3 (P < 0.0001). Percentage decreases (baseline to Year 3) were greater with the 44 μg dose than with the 22 μg dose for T2 lesion volume (-10.2% vs -4.5%, P = 0.025) and T1 BH volumes (-7.8% vs +10.3%, P = 0.002). A decrease in T2 lesion volume over 3 years predicted stable QoL over the same time period. Treatment with IFN β-1a, 44 μg sc tiw, predicted an absence of cognitive impairment at Year 3.
Subcutaneous IFN β-1a significantly decreased MRI measures of disease, with a significant benefit shown for the 44 µg over the 22 µg dose; higher-dose treatment also predicted better cognitive outcomes over 3 years.