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We evaluated the risk of worsening according to the length of exposure to interferon beta (IFNβ) in a 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 IFNβ 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 IFNβ 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 IFNβ treatment was lower (p<0.0001) in patients exposed to IFNβ for up to two years than in other groups. A clinical stabilization over two years of IFNβ exposure may predict a subsequent good clinical response to treatment. [ABSTRACT FROM AUTHOR]

Secondary progressive multiple sclerosis (SPMS) is a form of MS characterized by continuously worsening disability with or without superimposed relapses that occurs after a variable period of relapsing remitting disease and results in limited ambulation for almost all patients. The use of interferon beta (IFN β) for immunomodulation in patients with SPMS has been evaluated in four recent clinical trials: The European multicentre trial on IFN β-1b in SPMS (EUSPMS), the Secondary Progressive Efficacy Trial of Rebif (IFN β-1a) in MS (SPEC TRIMS), the North A merican Study of IFN β-1b in SPMS (NA SPMS), and the Internatio nal MS Secondary Progressive Avonex C linical Trial (IMPACT). EUSPMS was the only trial to demonstrate a significant positive effect of therapy on disease progression as measured by the expanded disability status scale (EDSS). However, results from all studies demonstrated significant positive effects of treatment on relapse, T2 lesion load, and gadolinium enhancement. Immunomodulation with IFN β has the potential to significantly slow disease progression and improve quality of life for patients with SPMS. While results with monthly IV Ig were disappointing, positive effects on disease progression have been reported with the applicatio n of immunosuppressants, especially Mitoxantrone. The risk-benefit ratio of these cytostatic agents remains controversial. New strategies addressing the important neurodegenerative aspects of the disease are urgently needed. [ABSTRACT FROM AUTHOR]