Epub: Rossi S et al. Effect of Glatiramer acetate on disease reactivation in MS patients discontinuing natalizumab. Eur J Neurol. 2012 Jun 28. doi: 10.1111/j.1468-1331.2012.03794.x.
BACKGROUND AND PURPOSE: MSers discontinuing natalizumab are at risk of rebound of disease activity.
METHODS: In the present multi-center, open-label, non-randomized, prospective, pilot study, the investigators’ tested whether treatment with glatiramer acetate (GA) is safe and effective after natalizumab in MSers. The study was performed at academic tertiary medical centers. 40 active relapsing-remitting MSers who never failed GA therapy and who discontinued natalizumab after 12-18 months of therapy were enrolled. GA was initiated 4 weeks after the last dose of natalizumab.
RESULTS: 62.5% of MSers were relapse-free 12 months after GA initiation. Annualized relapse rate and time to relapse were significantly lower than before natalizumab. Notably, the frequency of relapses was significantly lower amongst those MSers who had experienced ≤2 relapses the year before initiation of natalizumab therapy, compared with patients who had had three or more relapses. No evidence of rebound was observed in MRI scans. Furthermore, EDSS and MSFC were stable in MSers, again suggesting that 12 months of post-natalizumab-GA therapy is not associated with clinical deterioration.
CONCLUSIONS: Following discontinuation of natalizumab, twelve-month therapy with GA is safe and well tolerated in MSers. GA can reduce the risk of early reactivation/rebound of disease activity in this setting.
Acknowledgements: The present investigation was supported by a grant from Teva Pharmaceutical Industries.
“A reassuring result for GA-naive MSers, who are JCV seropositive on natalizumab, and are therefore at high risk of developing PML; they can descalate their therapy from natalizumab to GA and still expect a reasonable response. In the UK this would be very cost-effective as GA is the cheapest DMT by far (~£5,200 0r $8,000 per year) compared to natalizumab treatment that comes in at ~£25,000 or $37,000 per year!”
“There is one glaring sticking point regarding these results; the study was sponsored by Teva, the company that manufactures and markets GA. To be confident about the results it would be important to see the results reproduced by a study independent of Teva. Please note that by knowing about these conflicts of interest I do not place much weight on the findings of this study in isolation. This is why I wish Zamboni had declared his conflicts of interest when he published his first paper on CCSVI; we may be in a very different place now and several MSers who have died from unlicensed CCSVI procedures, done outside of ethically-approved clinical trials, may be alive today to read this blog. Sad?”