T Kalincik1, D Horakova, O Dolezal, J Krasensky, M Vaneckova, Z Seidl, E Havrdova. 1. Department of Neurology and Center of Clinical Neuroscience, Charles University in Prague, 1st Faculty of Medicine and General University Hospital in Prague, Czech Republic. tomas.kalincik@unimelb.edu.au
Abstract
OBJECTIVE: To evaluate long-term effects of 2-year treatment with interferon beta combined with low-dose azathioprine and prednisone in 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. RESULTS: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. CONCLUSION: The tested combined therapeutic regimen does not improve long-term outcomes in patients with multiple sclerosis. Furthermore, interferon is not able to completely abolish disease activity.
RCT Entities:
OBJECTIVE: To evaluate long-term effects of 2-year treatment with interferon beta combined with low-dose azathioprine and prednisone in 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. RESULTS: 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. CONCLUSION: The tested combined therapeutic regimen does not improve long-term outcomes in patients with multiple sclerosis. Furthermore, interferon is not able to completely abolish disease activity.
Authors: R Zivadinov; N Bergsland; O Dolezal; S Hussein; Z Seidl; M G Dwyer; M Vaneckova; J Krasensky; J A Potts; T Kalincik; E Havrdová; D Horáková Journal: AJNR Am J Neuroradiol Date: 2013-04-11 Impact factor: 3.825
Authors: Tomas Kalincik; Manuela Vaneckova; Michaela Tyblova; Jan Krasensky; Zdenek Seidl; Eva Havrdova; Dana Horakova Journal: PLoS One Date: 2012-11-15 Impact factor: 3.240
Authors: Robert Zivadinov; Carmen Tekwe; Niels Bergsland; Ondrej Dolezal; Eva Havrdova; Jan Krasensky; Michael G Dwyer; Zdeněk Seidl; Deepa P Ramasamy; Manuela Vaneckova; Dana Horakova Journal: Mult Scler Int Date: 2013-01-10