“This study below reports the MRI outcome of the REFLEX study that looked at the effectiveness of IFNbeta-1a subcutaneously 3X per week vs. FNbeta-1a subcutaneously1X per week vs placebo. The remarkable observation is how effective the 1X week dose is. The results suggest that if you start usin IFNbeta early in the course of MS it works better or you are more likely to respond. I wonder if there is a case to be made on cost-effectiveness grounds to try someone on the 1X per week dose first to see if they respond before escalating them to a more effective dose or treatment? This would bring down the costs of the 1st-line treatment by a third, which will make a big difference for beleaguered payers.”
Epub: De Stefano et al. Efficacy of subcutaneous interferon β-1a on MRI outcomes in a randomised controlled trial of patients with clinically isolated syndromes. J Neurol Neurosurg Psychiatry. 2013 . doi: 10.1136/jnnp-2013-306289.
AIM: The REbif FLEXible dosing in early MS (REFLEX) study compared several brain MRI outcomes in patients presenting with clinically isolated syndromes suggestive of multiple sclerosis and treated with two dose-frequencies of subcutaneous interferon (IFN) β-1a or placebo.
METHODS: MSers were randomised (1:1:1) to IFN β-1a, 44 µg subcutaneously three times a week or once a week, or placebo three times a week for up to 24 months. MRI scans were performed every 3 months, or every 6 months if the MSer developed clinically definite multiple sclerosis. End points analysed included: number of combined unique active lesions per patient per scan; numbers and volumes of new T2, T1 hypointense and gadolinium-enhancing (Gd+) lesions per patient per scan; and brain volume.
RESULTS: 517 MSers were randomised (intent-to-treat population: subcutaneous IFN β-1a three times a week, n=171; subcutaneous IFN β-1a once a week, n=175; placebo, n=171). Combined unique active lesions were lower in MSers treated with subcutaneous IFN β-1a versus placebo (mean (SD) lesions per MSer per scan: three times a week 0.6 (1.15); once a week 1.23 (4.26); placebo 2.70 (5.23); reduction versus placebo: three times a week 81%; once a week 63%; p<0.001) and with three times a week versus once a week (48% reduction; p=0.002). The mean numbers of new T2, T1 hypointense and Gd+ lesions were all significantly lower in the two active treatment arms compared with placebo (p≤0.004 for three times a week or once a week) and in the three times a week group compared with once a week (p≤0.012).
CONCLUSIONS: Both subcutaneous IFN β-1a 44 µg regimens improved MRI outcomes versus placebo, with the three times a week regimen having a more pronounced effect than once a week dosing.