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Natalizumab interruption results in a high rate of MRI and clinical MS disease activity recurrence



After a 24-week cessation of natalizumab treatment, a high rate of magnetic resonance imaging (MRI) and clinical disease activity recurs in patients with multiple sclerosis (MS) according to new research.

Natalizumab treatment duration has been associated with the development of progressive multifocal leukoencephalopathy (PML), a rare but often lethal and untreatable disorder of the central nervous system, characterized by large white-matter lesions that occur in immunocompromised patients. The RESTORE study was designed to investigate the effects of natalizumab interruption on MS disease activity.

Robert Fox, MD, of the Mellen Center for Multiple Sclerosis Treatment and Research at the Cleveland Clinic in Ohio, and colleagues conducted the randomized, partially placebo-controlled exploratory RESTORE study. The objective was to evaluate the effects of a 24-week treatment interruption on MS disease activity in 175 patients who had been relapse-free after treatment with natalizumab for a year or more and had no gadolinium-enhancing (Gd+) lesions on baseline MRI scan.......Read More - http://www.msrc.co.uk/index.cfm/fuseact ... ageid/1768

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Hmmm...not sure what to make of this study other than The Cleveland (Biogen rubber stamp) Clinic and Dr. Fox (makes a lot of money consulting for Biogen) conducted it.

I would imagine that the Copaxone people wouldn't be too pleased. 9% more of these patients needed "rescue" treatment than did the placebo patients! What does that say about the efficacy of Copaxone?

They took 175 patients who were doing well on Tysabri. We don't know the history of these patients or if they were already on another DMD treatment that wasn't working prior to starting Tysabri. You have to wonder if they took 175 patients who were doing well on any other DMD and stopped their treatment for 24 weeks, would the results be similar?

I'm thinking that Biogen's marketing/sales people could really use this study to convince neuros to leave their MS patients on Tysabri, regardless of the possible dangerous side effects from the drug. Then again, it'$ alway$ been about the revenue!

Harry

Apart from PML (not dying, but simply the effects of PML), my main concern is the "bounce" that people experience when they stop taking it, and so I have not tried this treatment. It would be seriously rubbish if I didn't respond all that well to Tysabri, but then became worse off, for stopping an ineffective treatment.

But, thinking about it again, PML is really scary; and I am not talking about death.

According to this study, there's an 87% chance of becoming moderately to severely disabled from PML.




NHE

I bet Biogen doesn't include this information in any of their Tysabri brochures!!

Harry

God help me today has been an awful day. I am so close to trying TY. I could be on within a week.. everything about TY scares me. I am not comfortable discussing it with my Tysabri friends. It's not fair to them. I have had a lot of numbness and nerve pain, it is getting worse. My family is pretty sure they don't want me on this medicine.. It gives me butterflies.. but it makes me feel some hope. I don't know why.
It makes me feel more scared.. MS is making me pretty scared too. I hate my neuro I think this is what he wants me to feel. He cannot see me any sooner than my scheduled appt.