BG-12 influence on relapse

Bar-Or A, Gold R, Kappos L, Arnold DL, Giovannoni G, Selmaj K, O’Gorman J, Stephan M, Dawson KT. Clinical efficacy of BG-12 (dimethyl fumarate) in patients with relapsing-remitting multiple sclerosis: subgroup analyses of the DEFINE study. J Neurol. 2013

Background: In the double-blind, placebo-controlled, Phase 3 DEFINE study in patients with relapsing-remitting multiple sclerosis, oral BG-12 (dimethyl fumarate) significantly reduced the proportion of patients relapsed (primary endpoint), the annualized relapse rate (ARR), and confirmed disability progression (secondary endpoints) at two years compared with placebo.

Objective: We investigated the efficacy of BG-12 240 mg twice daily (BID) and three times daily (TID) in patient subgroups stratified according to baseline demographic and disease characteristics including gender, age, relapse history, McDonald criteria, treatment history, expanded disability status scale score, T2 lesion volume, and gadolinium-enhancing lesions.

Results: The clinical efficacy of BG-12 was generally consistent across patient subgroups and reflected positive findings in the overall DEFINE study population. Treatment with BG-12 BID and TID reduced the proportion of patients relapsed and the ARR at two years compared with placebo in all patient subgroups. Reductions in the risk of relapse with BG-12 BID vs. placebo ranged from 68 % [hazard ratio 0.32 (95 % confidence interval (CI) 0.16-0.62)] to 26 % [0.74 (0.51-1.09)] and from 66 % [0.34 (0.23-0.50)] to 25 % [0.75 (0.42-1.36)] with BG-12 TID vs. placebo. BG-12 also reduced the risk of disability progression at two years compared with placebo in most subgroups of patients treated with the BID dosing regimen and in all subgroups treated with the TID regimen. Conclusion: These analyses indicate that treatment with BG-12 is consistently effective across a wide spectrum of patients with relapsing-remitting multiple sclerosis with varied demographic and disease characteristics.

This is hot on the tails of the results from the CONFIRM study:

Hutchinson M, Fox RJ, Miller DH, Phillips JT, Kita M, Havrdova E, O’Gorman J, Zhang R, Novas M, Viglietta V, Dawson KT. Clinical efficacy of BG-12 (dimethyl fumarate) in patients with relapsing-remitting multiple sclerosis: subgroup analyses of the CONFIRM study.J Neurol. 2013 Jun 8.

Prof G forgot to post on this one, maybe too modest…so when you ask have you done anything for MS he can hold is head up high and say he has been doing his bit.

CoI: Multiple. Prof G is a co-author of this paper and have received consultancy fees from Biogen

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  • "so when you ask have you done anything for MS he can hold is head up high and say he has been doing his bit"

    He can hold his wallet up high! Biogen paid him to do this work – there's no philanthropy here. Such consultancy fees are a nice little earner. Hope he has time to do his NHS work / Queen Mary's work.

    I now see the attraction of MS research.

    • Dammed if you do and dammed if you don't

      We have been here before…..and this goes nowhere bar some steam letting.

      Read through the blog and read about NHS commitments,academic commitments, consultancies, private practice (a more consistent earner..not done I may add) and the requirements for industry to recompense academics for their services.

      As for doing trials any money goes to the university/hospital and not the private purse

      Consultancy is different it can go in your pocket and you pay tax, it can go into a slush fund in the university, which you use to send students to conferences, pay for research days which don't grow on trees or pay people salaries so they can work to try and help MSers.

    • You get FDA and EMA approval and the MSers get access to a new MS drug.

      This is what has happened in the US and the uptake has exceeded expectations. In the UK, Biogen will set a price if it is too high NICE will stick its oar in and then the NHS will haggle about cost and access to the drug will be delayed.

      If Biogen think about it and ask a realistic price then people with MS get the drug and they get the lions share of the MS markets before any of the newer DMT can get in there because they are either not first line or cost too much.

      Lemtrada is in the hunt for the first line pot, how much will they charge.

      I wonder if Gilenya was cheaper whether it would be first line in UK, I suspect so and it would be harder for any newcommers to make an in road.
      A bit of price competition would shake this up.

      Once they are making cash no doubt Biogen will think/have thought about studies in progressive MS as the mechanisms of action targeting Nrf2 suggests it should be neuroprotective…….maybe they will just ride on the coat tails of this and not prove it as negative data is not good for sales.

    • You almost make it sound like it might become a front line treatment under the NHS!

      I really hope so, the argument for lowering the price for the NHS surely gives a much better return to the drugs company than making the price too high and forcing non-first line status. They must have to treat the NHS as a special case in this regard. Lowering the price means more return to the drugs company as it gets to a lot more people and a whole bunch of satisfied MS patients. Gilenya has already missed that boat…

      Hope this gets through to be a first line treatment…

    • I'm not a regulator or party to Biogens Accounts ear if the price is right I hope it will get first line option. Alemtuzumab as first line has set precedent

  • I'm (only) an MS sufferer and I am genuinely excited about the range of treatments now available for RRMSers. This does not help me because I have SPMS but I'm sure there will be licensed treatments available sooner rather than later. My fingers are crossed

  • What are your thoughts on Tecfidera vs. Lemtrada or the other more effective disease modifying agents? Is, in your opinion, it worth starting out on Tecfidera or Gilenya or is this also wasting time similar to using Copaxone or Avonex hoping for "benign MS" — if you have the choice to use one of the best agents?

    Thanks for all your hard work!

    • This a question of choice. All that Prog G can do is provide you with the details of each and then it is your choice. Each one has some pros and cons no doubt we will see a head to head of these drugs at some stage to see if if one is really any better than the other. I suspect they are relatively similiar.

      One is an short course and then serial monitoring the others are treatments every day. IS it more re-assurring to take something every day or is that more of a pain…individual choice.

    • Thanks MD. You suspect that the results comparing Tecfidera and Lemtrada may be relatively similar?

      With all the posts in the last few months about possibly "flat-lining" with Lemtrada or the other top line treatments, I am excited about the possibility -even if it is not guaranteed- of flat-lining. I am still relatively newly diagnosed and debating whether to switch to Tecfidera or ask for Rituxan or Lemtrada when it comes out (if my neuro will prescribe it, currently on Copaxone). Before I incur more serious disability I want to make the most informed decision I can. Thanks for all your time posting and responding to comments. I know you are a busy man and I appreciate your time.

    • Yes you are right Tecfidera=BG-12

      If you compare gilenya nataluzimab cladribine etc. they are pretty similar but unless you do head to head harder to say.

      Obviously Lemtrada was put against beta interferons, unethical to have placebo these days but also good marketing oppertunity to say mines better than yours

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