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Multiple Sclerosis, Vol. 12, No. 5, 578-585 (2006)
DOI: 10.1177/1352458506070620

The Italian Multiple Sclerosis Database Network (MSDN): the risk of worsening according to IFNß exposure in multiple sclerosis

Maria Trojano

Department of Neurological and Psychiatric Sciences, University of Bari, Bari, Italy, mtrojano{at}neurol.uniba.it

Pierluigi Russo

Department of Critical Area, University of Florence, Florence, Italy

Aurora Fuiani

Department of Neurological and Psychiatric Sciences, University of Bari, Bari, Italy

Damiano Paolicelli

Department of Neurological and Psychiatric Sciences, University of Bari, Bari, Italy

Elisabetta Di Monte

Department of Neurological and Psychiatric Sciences, University of Bari, Bari, Italy

Enrico Granieri

Department of Neurology, University of Ferrara, Ferrara, Italy

Giulio Rosati

Department of Neurology, University of Sassari, Sassari, Italy

Giovanni Savettieri

Department of Neurology, Ophthalmology, Otolaryngology and Psychiatry University of Palermo, Palermo, Italy

Giancarlo Comi

Department of Neurology, University Vita Salute IRCCS S. Raffaele, Milan, Italy

Paolo Livrea

Department of Neurological and Psychiatric Sciences, University of Bari, Bari, Italy

MSDN Study Group

We evaluated the risk of worsening according to the length of exposure to interferon beta (IFNß)ina large cohort of 2090 multiple sclerosis patients collected by the Italian MS Database Network. Overall 44-140 patient-visits with a follow-up of 22-143 patient-years were evaluated. Forty-one per cent of patients were exposed to IFNß for up to 2 years, 39% for 2- 4 years and 20% for more than 4 years. A Cox regression model was used to analyse two clinical outcomes: disability progression and worsening of relapse rate. The technique of propensity score was applied to reduce bias in the comparison of non-randomized groups. The risks of disability progression (HR=0.23; 95% CI: 0.17 - 0.30) and worsening of relapse rate (HR=0.19; 95% CI: 0.14 - 0.27) were reduced by about 4- 5- fold in patients exposed to IFNß for more than four years, compared with patients exposed for up to two years. The propensity score technique confirmed the findings. The proportion of days covered by IFNß treatment was lower (P<0.0001) in patients exposed to IFNß for up to two years than in other groups. A clinical stabilization over two years of IFNß exposure may predict a subsequent good clinical response to treatment.

Key Words: IFNß • long term effectiveness • multiple sclerosis • observational studies


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