Are you are natalizumaber who is gambling on not getting PML? #ClinicSpeak #NeuroSpeak #MSBlog
Recently, I haven't been updating you regularly about natalizumab-associated PML. After the recent blog traffic around alternative facts and the EudraVigilance PML figures I thought I should resume and start posting the official Biogen figures every quarter.
The following is Biogen's quarterly update; if you are not a HCP you shouldn't be reading the document. The headline data is that there are now 161,300 pwMS who have been exposed to natalizumab with over 525,000 patient-years of exposure. As of the 1st December 2016 there have been 698 confirmed cases of PML (695 with MS and 3 with Chron's disease). The mortality of PML in these patients has been 23%, i.e. 161 people have died.
My opinion is that nobody who is JCV seropositive should be started on natalizumab and those who are seropositive on the drug should be derisked and switched to an alternative treatment. The use of the JCV antibody index may reassure some people that they are at low risk, but at the end of the day the risk is not zero. Despite me giving this advice several of our patients are reluctant to stop natalizumab simply because they know how bad their MS was before they started the drug and don't want to take a chance of rebound activity or not responding to the switch therapy.
Labels: #ClinicSpeak, #PoliticalSpeak, Biogen, natalizimab, PML, PML Risk, PML Risk update