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.”
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.)
- Two cases had confounding medical conditions (1 previous cancer and 1 ulcerative colitis/immunosuppressive therapy).
- One patient had previous natalizumab exposure for 10 months (3 years 9 months before PML diagnosis)
- In one patient, PML occurred during 3-month natalizumab exposure, after 4.5 years fingolimod treatment; this patient also had a history of recent exposure to steroids
- Twelve of the 13 patients were within the age range of 43 to 63 years, while one patient was 34 years old
- Twelve of the 13 patients had fingolimod exposure ranging between 29 and 75 months, while one received fingolimod for 18 months
- There was no pattern of sustained grade 4 lymphopenia; JCV DNA PCR test was positive in all cases.