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

Stefano Bastianello, Elisabetta Giugni, Maria P. Amato, Maria Rosalia Tola, Maria Trojano, Stefano Galletti, Giacomo Luccichenti, Mario Quarantelli, Orietta Picconi, Francesco Patti

Research output: Contribution to journalArticle

Abstract

Background: 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.Methods: 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.Results: 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.Conclusion: 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.

Original languageEnglish
Article number125
JournalBMC Neurology
Volume11
DOIs
Publication statusPublished - Oct 14 2011

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Relapsing-Remitting Multiple Sclerosis
Interferons
Multiple Sclerosis
Magnetic Resonance Imaging
Quality of Life
Cognitive Dysfunction
Gadolinium
Therapeutics
Observational Studies
Clinical Trials

ASJC Scopus subject areas

  • Clinical Neurology

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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. / Bastianello, Stefano; Giugni, Elisabetta; Amato, Maria P.; Tola, Maria Rosalia; Trojano, Maria; Galletti, Stefano; Luccichenti, Giacomo; Quarantelli, Mario; Picconi, Orietta; Patti, Francesco.

In: BMC Neurology, Vol. 11, 125, 14.10.2011.

Research output: Contribution to journalArticle

Bastianello, Stefano ; Giugni, Elisabetta ; Amato, Maria P. ; Tola, Maria Rosalia ; Trojano, Maria ; Galletti, Stefano ; Luccichenti, Giacomo ; Quarantelli, Mario ; Picconi, Orietta ; Patti, Francesco. / 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. In: BMC Neurology. 2011 ; Vol. 11.
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abstract = "Background: 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.Methods: 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.Results: 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.Conclusion: 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.",
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AU - Bastianello, Stefano

AU - Giugni, Elisabetta

AU - Amato, Maria P.

AU - Tola, Maria Rosalia

AU - Trojano, Maria

AU - Galletti, Stefano

AU - Luccichenti, Giacomo

AU - Quarantelli, Mario

AU - Picconi, Orietta

AU - Patti, Francesco

PY - 2011/10/14

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N2 - Background: 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.Methods: 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.Results: 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.Conclusion: 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.

AB - Background: 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.Methods: 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.Results: 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.Conclusion: 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.

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