The RESTORE trial: What did we learn about MS?

[MSUK]

RESTORE was a randomized, partially placebo-controlled exploratory study evaluating multiple sclerosis (MS) disease activity during a 24-week interruption of natalizumab. The objectives of RESTORE were to explore the course of MS disease activity and the effects on pharmacokinetic, pharmacodynamic, and immune parameters in patients undergoing an interruption of natalizumab therapy for up to 24 weeks as compared with those in patients remaining on natalizumab. It also assessed the effects of alternate therapies during natalizumab interruption and after restarting natalizumab. Patients with MS receiving natalizumab were randomized into three treatment arms in a 1:1:2 ratio: natalizumab:placebo:alternate immunomodulatory therapy (interferon b-1a, glatiramer acetate or methylprednisolone)........ Read More - http://www.ms-uk.org/tysabri

[HarryZ]

RESTORE was a randomized, partially placebo-controlled exploratory study evaluating multiple sclerosis (MS) disease activity during a 24-week interruption of natalizumab. The objectives of RESTORE were to explore the course of MS disease activity and the effects on pharmacokinetic, pharmacodynamic, and immune parameters in patients undergoing an interruption of natalizumab therapy for up to 24 weeks as compared with those in patients remaining on natalizumab. It also assessed the effects of alternate therapies during natalizumab interruption and after restarting natalizumab. Patients with MS receiving natalizumab were randomized into three treatment arms in a 1:1:2 ratio: natalizumab:placebo:alternate immunomodulatory therapy (interferon b-1a, glatiramer acetate or methylprednisolone)........ Read More - http://www.ms-uk.org/tysabri

"Disease recurred in a large proportion of RESTORE patients who discontinued natalizumab treatment."

It's too bad they didn't give any numbers as opposed to this kind of statement. So they took 128 patients (presumably RRMS but they didn't say) gave them a very powerful immune system altering drug (Tysabri) then took a percentage off the drug for the remaining 20 weeks....some on Placebo, some on Copaxone and some on Interferon.

And came to the conclusion that "a large proportion" ended up with disease activity returning. Hmmm....a detailed, intense trial or a marketing trial done to improve Tysabri sales. Anyone else doing a MS drug trial lasting 24 weeks and then coming to a conclusion would be tared and feathered for making that kind of statement. You can make your own conclusions.

But hey, this is the world of MS drugs and gaining a percentage or two of the market share can result in a huge revenue increase.