Saturday, 29 July 2017

#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.)
  • 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.
CoI: multiple

4 comments:

  1. "Professor Giovannoni and his group have received research grant support from ....Novartis"

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  2. I do not think Novartis should be commended on updating # of PML cases. Not reporting it should mean the drug is immediately removed from market and their CEO should be in jail and the company gets a massive fine. Mandatory updates on severe adverse reactions should be the norm for every drug.

    Also, 1 case of pml is too many with its devastating consequences. I am not sure how pharma gets away without having developed a treatment for JCV. Maybe they should spend some of their billions made on R&D of an antidote for PML.

    ReplyDelete
    Replies
    1. https://www.sciencedaily.com/releases/2015/09/150924101851.htm

      Delete
    2. Thank-you very much MD2 for this. This anti-JCV treatment should have been on the market many years ago (before Gilenya, Tecfidera, Tysabri, etc) with the release of of any of the immunosuppressant drugs as PML was a known severe side effect. Pharma could have de-risked Tysabri and GIlenya almost completely.

      Delete

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