Tuesday, 12 April 2016

Real life activity of fingo and natalizumab

Koch-Henriksen N, Magyari M, Sellebjerg F, Soelberg Sørensen P. A comparison of multiple sclerosis clinical disease activity between patients treated with natalizumab and fingolimod.
Mult Scler. 2016 Apr 7. pii: 1352458516643393. [Epub ahead of print]


BACKGROUND:Natalizumab and fingolimod were approved for treatment of active relapsing-remitting multiple sclerosis (RRMS) in Denmark in 2006 and 2011, respectively. There have been no randomized head-to-head studies comparing the two drugs.
OBJECTIVE:To compare the clinical efficacy of natalizumab and fingolimod.
METHODS:Data on all Danish RRMS patients who started their first second-line treatment with natalizumab or fingolimod from July 2011 to March 2015 were prospectively recorded in the Danish Multiple Sclerosis (MS) Treatment Register. The two treatment arms were 1:1 propensity score matched by baseline covariates using 'nearest neighbour' method.
RESULTS:Propensity score matching left 928 of 1309 RRMS cases, 464 in each treatment group. The on-treatment annualized relapse rate was 0.296 (95% confidence interval (CI): 0.26-0.34) for natalizumab and 0.307 (95% CI: 0.27-0.35) for fingolimod. The adjusted relapse rate ratio was 0.93 (95% CI: 0.74-1.17; p = 0.53). Mean time to first relapse was 2.55 and 2.56 years, respectively (p = 0.76). There was no difference in change of Expanded Disability Status Scale (EDSS).
CONCLUSION:We found no differences in clinical disease activity between natalizumab- and fingolimod-treated RRMS patients in this real-life observational study. However, the lack of magnetic resonance imaging (MRI) data for the propensity score matching may conceal a higher efficacy of natalizumab
This study looks at the relapse rate of people taking natalizumab and fingolimod in Denmark and says the effect is about the same in terms of relapse rate. 

So if this is the case one would think this would be the end of natalizumab because it has more risk of PML than fingolimod so why take the risk when the efficacy of fingo is just as good. Novartis shout "Hooray". 

Is the choise of which second line DMT influenced by activity of disease so are you comparing like with like and as fingolimod was not approved until 2010 starting at 2006 means that from 2006-2010 there was only one choice unless one was part of a trial. 

So whilst saying there is no difference they have the proviso that if there was imaging natalizumab would have won...Biogen shout "Hooray". Indeed we have recently reported that relapses post natalizumab swithcing because of JC virus and PML risk not efficacy occurred with fingolimod (20%). However treatment choice is not simply about efficacy because if that were the case them people would be using alemtuzumab and HSCT more.

Do companies shout "Hooray" when they get good news about their drug...well DrK spotted a group of reps doing just that "in public"....maybe it meant a bonus was coming their way...Hooray

5 comments:

  1. Is there any research evaluating the risk of PML in Cladribine? Or just have to cancers?

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    Replies
    1. It is very low, DrK has does not know a case in MS and in other conditions it is low too I believe. However never say never I am sorry to say

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    2. It is very low, DrK has does not know a case in MS and in other conditions it is low too I believe. However never say never I am sorry to say

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  2. "The two treatment arms were 1:1 propensity score matched by baseline covariates using 'nearest neighbour' method."

    Does that mean the disease was equally active in the groups treated with the different drugs? If not, that would be a problem with the study wouldn't it?

    ReplyDelete
    Replies
    1. I think it means they started in the same place

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