#NewsSpeak & #ClinicSpeak: PML and fingolimod

How common is PML in fingolimoders? #NewsSpeak #ClinicSpeak

I would like to congratulate Novartis for providing periodic updates on the PML risk associated with fingolimod. There have now been 13 cases of PML on fingolimod unrelated to prior natalizumab exposure, which provides a risk of getting PML on fingolimod of less than 1 in 10,000.

Please note that the PML risk, and other opportunistic infection risk, is unrelated to your lymphocyte count, which is why you can't derisk the problem on fingolimod. You simply need to vigilant and  take any new neurological, and other, symptoms seriously and report them to your MS HCP (healthcare professional). 

"I could not bring myself to believe that if knowledge presented danger, the solution was ignorance. To me, it always seemed that the solution had to be wisdom. You did not refuse to look at danger, rather you learned how to handle it safely." 
Issac Asimov

Novartis Quarterly PML Update

The overall rate of confirmed PML under fingolimod therapy not attributed to previous natalizumab treatment is very rare and estimated to be less than 1:10,000 patients

13 confirmed PML cases in >213,000 fingolimod treated patients (>453,000 patient-years) as of May 2017.

(Estimated risk (95% CI) is 0.061 (0.032, 0.1)/1,000 patients and incidence rate (95% CI) is 2.87 (1.53, 4.9)/100,000 patient-years exposure.)
CoI: multiple

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