Thursday, 27 September 2012

Research: Predicitng freedom from disease after tysabri

EpubProsperini et al. Predictors of freedom from disease activity in natalizumab treated-patients with multiple sclerosis.J Neurol Sci. 2012 Sep 21. pii: S0022-510X(12)00479-0. doi: 10.1016/j.jns.2012.08.027.

PURPOSE: To identify baseline predictors of the response to natalizumab in patients with relapsing-remitting multiple sclerosis (RRMS).
METHODS: We prospectively collected clinical and magnetic resonance imaging (MRI) data of RRMS patients treated with natalizumab and followed-up for 24months. They were categorized according to different outcomes of response to natalizumab: (i) "full" responders, i.e. those having no relapses, no sustained disability worsening on Expanded Disability Status Scale (EDSS), and no MRI activity; (ii) "partial" responders, i.e. those having MRI activity, but not relapses and/or EDSS worsening; and (iii) "poor" responder, i.e. those experiencing relapses and/or EDSS worsening.
RESULTS: We analysed data of 210 RR-MS patients (147F, 63M); at the end of the 24-month study period, 120 (57.1%), 36 (17.1%), and 54 (25.8%) patients were defined as "full", "partial" or "poor" responders, respectively. Thirty-two (89%) patients classified as "partial" responders experienced MRI activity at the 6-month scan; the majority of them had >2 contrast-enhancing lesions at baseline MRI scan or >2 relapses in the year prior to starting therapy. A "full" response to natalizumab was found more likely in patients with ≤2 relapses in the year prior to treatment start (OR=3.68; p=0.002), and in those with an EDSS score ≤2.5 at baseline (OR=3.60; p<0.001). Accordingly, patients with >2 relapses in the year prior to treatment start, or those with an EDSS score ≥3.0 at baseline were more likely to be classified as "poor responders". These figures were replicated even after excluding 20 patients who developed anti-natalizumab antibodies.

CONCLUSION: Our results suggest that natalizumab may lead to a complete remission of MS if started in patients with less aggressive disease (i.e. few relapses and mild disability), thus suggesting its possible role as first switching option, or even first-line therapy, at least in JCV-negative patients. We also support the recommendation against an immediate discontinuation of despite the occurrence of MRI activity in the first few months of treatment, since the freedom from clinical disease activity could be still achieved.

Whilst posting the study on employment it is perhaps relevant that we mention this new study too. This looked at people who take Tysabri and see how well people do on this. Notably they looked to see if disease activity was squashed or whether there was some grumbling disease still going on. As can be seen this is not a cure as most people still had some disease activty, but there were some people who did very well and these were people with early and mild disease, This is further evidence for striking early with effective DMT.


  1. Would you have a break down of those results for full responders?

    sex, age, race....

    Last, have you seen any work done on a time frame longer than 2 years?

    would be interesting to know the disease status of "full responders" after a 5 or 6 year treatment with Tysabri...


  2. So the people who did best on Tysabri were people in the early stages of MS with a mild form, interesting.Without knowing what course their MS would have taken without Tysabri is it fair to say it doesn't tell us that much ? given the unpredictable nature of MS.If one was to take that same approach it would be better for statistical outcome to prescribe it to someone without MS and measure that outcome would it not ?

  3. Without knowing what course their "MS would have taken without Tysabri is it fair to say it doesn't tell us that much?"

    No not really it is not fair to say because the the outcome was baased on what happened BEFORE treatmet started.

    So this could give someone making a decision about treatment what could happen. In the UK you are given little choic in drugs at the moment, in the USA the choice range is bigger. So with this knowledge in hand it may help you chose one way or another.

    "If one was to take that same approach it would be better for statistical outcome to prescribe it to someone without MS"

    ?. Maybe this is not what you wanted to say but this makes no sense to me. You do not give drugs to people that do not have the disease. Maybe explain in another way.


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