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.