Kalincik T et al. – The tested combined therapeutic regimen does not improve long–term outcomes in patients with multiple sclerosis.Methods
- In the original 2–year ASA study, 181 patients with early relapsing–remitting multiple sclerosis were randomised into 3 treatment arms: those treated with interferon beta (n=60), with interferon beta and low–dose azathioprine (n=58), and interferon beta, azathioprine and low–dose prednisone (n=63).
- Of these, 172 were included in this 4–year non–study extension.
- Three monthly clinical controls and annual MRI scans were carried out.
- The primary endpoint was annual relapse activity.
- The secondary endpoints were disability and quantitative MRI parameters.
- Nine patients were lost to follow–up and 172 were included in the analyses.
- None of relapse activity, disability accumulation or MRI parameters differed significantly between the groups over 6 years.
- Only 5.5% and 0.6% of patients were free from disease activity at year 2 and year 6 of the treatment initiation.