Friday, 6 May 2016

Natalizumab is more effective than the CRAB drugs

Spelman T, Kalincik T, Jokubaitis V, Zhang A, Pellegrini F, Wiendl H, Belachew S, Hyde R, Verheul F, Lugaresi A, Havrdová E, Horáková D, Grammond P, Duquette P, Prat A, Iuliano G, Terzi M, Izquierdo G, Hupperts RM, Boz C, Pucci E, Giuliani G, Sola P, Spitaleri DL, Lechner-Scott J, Bergamaschi R, Grand'Maison F, Granella F, Kappos L, Trojano M, Butzkueven H. Comparative efficacy of first-line natalizumab vs IFN-β or glatiramer acetate in relapsing MS. Neurol Clin Pract. 2016;6(2):102-115.

BACKGROUND:We compared efficacy and treatment persistence in treatment-naive patients with relapsing-remitting multiple sclerosis (RRMS) initiating natalizumab compared with interferon-β (IFN-β)/glatiramer acetate (GA) therapies, using propensity score-matched cohorts from observational multiple sclerosis registries.
METHODS:The study population initiated IFN-β/GA in the MSBase Registry or natalizumab in the Tysabri Observational Program, had ≥3 months of on-treatment follow-up, and had active RRMS, defined as ≥1 gadolinium-enhancing lesion on cerebral MRI at baseline or ≥1 relapse within the 12 months prior to baseline. Baseline demographics and disease characteristics were balanced between propensity-matched groups. Annualized relapse rate (ARR), time to first relapse, treatment persistence, and disability outcomes were compared between matched treatment arms in the total population (n = 366/group) and subgroups with higher baseline disease activity.
RESULTS:First-line natalizumab was associated with a 68% relative reduction in ARR from a mean (SD) of 0.63 (0.92) on IFN-β/GA to 0.20 (0.63) (p[signed-rank] < 0.0001), a 64% reduction in the rate of first relapse (hazard ratio [HR] 0.36, 95% confidence interval [CI] 0.28-0.47; p < 0.001), and a 27% reduction in the rate of discontinuation (HR 0.73, 95% CI 0.58-0.93; p = 0.01), compared with first-line IFN-β/GA therapy. Confirmed disability progression and area under the Expanded Disability Status Scale-time curve analyses were not significant. Similar relapse and treatment persistence results were observed in each of the higher disease activity subgroups.
CONCLUSIONS:This study provides Class IV evidence that first-line natalizumab for RRMS improves relapse and treatment persistence outcomes compared to first-line IFN-β/GA. This needs to be balanced against the risk of progressive multifocal leukoencephalopathy in natalizumab-treated patients.

This gives evidence that natalizumab is more effective than the CRAB drugs when used as first line. But you know this already. This needs to be offset by the increased risks of side effects

16 comments:

  1. What a waste of money and time. I wonder if this is an April fool joke as one of the contributors is A Prat. We need a new system for MS research where the only research which is funded relates to new work / new insights not SOTBO (statements of the bloody obvious). I might publish a paper called MS Researchers are useless. My evidence will be the lack of any real understanding of the cause of the disease (after 60 years of research efforts). It will be easily reproduceable by others across the world. I would also bring back hanging for any researcher who publishes an EAE paper and any neuro who flies more than 10,000 miles a year. MS researchers and neuros need a bloody good shake up - the paper above make my blood boil.

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    1. Alexandre Prat is French Canadaian and is pronounced with a silent t and is a respected neurologist and researcher.

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    2. Dear MS researchers,
      Please use precious research money on new findings. Let's not waste it on reinventing the wheel. Cheers.
      Regards,
      PwMS

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    3. Pharma loves this stuff. They get validated by well known researchers even though it really doesn't tell us anything we didn't already know. It's good for their bottom and the researchers can add a paper to their c.v. As "And so it goes.......where it's going no one knows... " https://m.youtube.com/watch?v=k3jiCi7aFZE.

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    4. https://www.youtube.com/watch?v=q_u2OK_IKw0

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    5. Vintage N. Lowe "...see the MS researcher, he's the one with the tired eyes....":-)

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    6. You have no idea just how appropriate that quote's going to be next week :-(

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    7. AnonymousFriday, May 06, 2016 8:01:00 am - made me laugh as I think another contributor is an April Fools joke but it's not Prat. My April Fools joke is also "a respected neurologist and researcher" (aren't they all lol). Funny thing, the person who performed my partner's LP at diagnosis choked as he was doing it (by his own admission), used a too big a needle and left the room abruptly after choking without giving my partner any post LP advice. I made a complaint about the incident. There was a bit of brown nosing in response, but someone actually had the nerve to tell my partner he is a good doctor. Good thing I wasn't there when it happened as I would have made another complaint about the comment lol... he may be a noble prize winner and the next einstein with a heart of gold, but whatever he is he didn't do the right thing by my partner and excusing it with some lame 'he's a good doctor' is just annoying lol. All I wanted to hear at the time is 'we're sorry and we will do some training to minimise it happening again'.

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  2. as a patient who has been on Tysabri since the phase two trials, I could have told anyone willing to listen how good this drug is. but its always nice to have it confirmed, thanks for posting this MD

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    1. It's never nice having CRABS.

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  3. Second line drugs reduces bvl, CRAB drugs do not. Bvl correlates best further disability. Crab drugs represent the past, second lines the present.

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  4. Worse still hear a PWMs using Natalizumab and had found the presence of JCV it maybe will return to using Interferon. I almost ask her "comes CaM but MS in you are not very active? What will you do returning to Interferon?", And she can try Fingolimod and/or Rituximab...

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