Could it be the women from the girls…I’ll be surprisied if there compassion over placebo

One of the interesting presentations at ECTRIMS 2015 will be the examination of the cells entering the CNS during rebound after Natalizumab.

ProfG menitoned that Biogen are aiming to deal with a Biogen problem and seeing if the can switch presumably JC positive MSers from natalizumab to daclizumab.

ProfG mentioned that beta interferons, glaterimer acetate and dimethyl fumarate are not good enough to stop this, so fingolimod is a reasonable next candidate.

The question I wonder is what is the trial design? 

Is it daclizumab after natalizumab in a superiority trial to be compared to placebo or known failure, so something like fingolimod after natalizumab.

I don’t know but would Biogen chance putting their drug against a Novaritis drug with the chance it could be worse…(It could be better)….this could be a marketing nightmare. 

Surely it will not be against placebo and destine those on placebo to a rebound relapse…..will it??. 

It seems that the guys on the FDA still support placebo-controlled trials for DMT ( I guess its not their brains being damaged)…but what does it say about ethics of the FDA and the ethical committees that approve these studies, in this day and age in that that they can willingly allow people to have relapses, when the trials should be non-inferiority against known effective treatments. 

It is amazing that people sign up to these trials if you can get access to a drug that you know works why would you risk getting placebo that you know does not work. Pharma have been doing trials where there is no access to DMT and so the chance of placebo (you do better in a trial) or drug verses nothing is appealing. However,one can again ask the question about the ethics of this.

However also economics come into it. If Biogen use fingolimod as a comparator they will have to pay for it and this adds to the cost so comparing against placebo or against a biogen drug (avonex, tecfidera-known failures) is a cheaper option.

This aspect was a realisation when we were costing for a trial of an of patent drug and an arm having a current DMT. If we do it under the National Institute Health Research the the cost of the DMT could come under NHS, but if not we may have to find the cost of the DMT meaning that no academic could do such a study, with an approved DMT as a comparator.

I also point out that I will get called a hypocrit because of the trial for a symptom control drug, I’m involve with that going to be against placebo.

I was not involved in the trial design this was the clinical team.

The reason for this was that we are ideally aiming to treat people who have spasticity but are not taking treatment because of side-effects potential or people who are willing to come off drug for a short while to take part in the trial, otherwise we will be saddled with the problem that occurred with sativex in that trials struggled to show an affect because is prescribed as an add-on to existing treatment and it was then only approved as an add-on and not a first line treatment.

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  • Well done MD on women from girls:)

    As to my faint glimmer if hope with daclizumab, it's pretty much dashed, and I'm resigning myself to possibly relapsing when I switch. Though as I feel like I'm having a relapse (apparently not) every month (must be all psychosomatic, hah), I'm not sure I could feel any worse with a real relapse.

    • I also feel that I have a relapse every week or so but my neuro doesn't believe.

      however, i felt like that last year quite often and when my mri came back I had 10 new lesions due to withdrawal of tecfidera and a reboud activity so i was right all the way.

      i pray for a blood test soon which would help diagnose new infammation/lesions cos it's horrible if you tell people that you're sick and they don't believe you!!!

    • Wow, I know what you mean. I'm feeling like I'm just seen as a 'pushy neurotic patient'. And I'm beginning to question my sanity. Not quite every week for me but for around ten days every 4 weeks (not counting the infusion reaction part that wipes out another 3-4 days with the pre-dose Iv antihistamine then post Ty oral piriton etc) and it is a lot worse than the actual relapses I've had.

      As Tysabri is raved about by the majority of people at the infusion unit I attend, it is really is hard (so far impossible) to find anyone with similar problems. I have to grit my teeth to actually attend, because it feels like I'm undergoing a form of torture every 4 weeks (dramatic I know but that's what it feels like).

    • If I had a doctor that didn't believe me if I told them I was ill, I'd go and see someone else. If it's the known side effects of treatment, that's another story.

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