PML carryover onto ocrelizumab

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I have just received the following information from Roche, which is reassuring in that

  • As of July 3rd 2019, the Roche can confirm there have been no new carry-over cases of PML in MS patients treated with ocrelizumab since their last update in April 2019. The seventh case was reported in March 2019.
  • As of April 2019, over 100,000 people have been treated with ocrelizumab globally, within a combination of clinical trial and post-marketing settings.
  • No unconfounded cases of PML with ocrelizumab have been reported to date.
  • Of the seven cases of carry-over PML, none were reported as fatal at the last point of follow up (Feb 2019).

Information relating to all carry-over cases has been reported to regulatory agencies in compliance with agreed pharmacovigilance processes.

The recommendations relating to PML in the approved product labelling for ocrelizumab remain unchanged. HCPs should be vigilant for early signs and symptoms of PML, which can include any new-onset, or worsening of neurological signs or symptoms, as these can be similar to an MS relapse. If PML is suspected, withhold dosing with ocrelizumab.

Summary of carry-over PML cases to date (July 2019):

Carry-over caseCountryReportedSettingCarry-over from
1GermanyMay 2017Compassionate Use programmeNatalizumab
2CanadaApril 2018Post-marketingFingolimod
3USAMay 2018Post-marketingNatalizumab
4USAJune 2018Post-marketingNatalizumab
5USAJuly 2018Post-marketingNatalizumab
6LuxembourgSeptember 2018Post-marketingNatalizumab
7USAFebruary 2019Post-marketingNatalizumab

Roche are sharing this information for full transparency and hope you find this useful.

About the author

Gavin

Professor of Neurology, Barts & The London. MS & Preventive Neurology thinker, blogger, runner, vegetable gardener, husband, father, cook and wine & food lover.

12 comments

  • I’m highly cynical when it comes to the word ” transparency ” and “Pharma” in the same sentence as a brain disorder

    😉

  • Roche are sharing this information in the knowledge that it will all come out somehow anyway and like to appear as though they care.

    • Roche does care. Ocrevus is a big and important product for them and hence they want people to know about its risks and benefits. Knowing about carry-over PML is just one aspect of its safety profile.

      • But, with respect Prof G, you say it yourself: Roche “cares” because it’s a big and important product for them, i.e. it’s all about the money. That’s caring for lining their pockets. I worry about the influence of pharma and greed in MS research. P-hacking, selecting likely responders for trials… Ocrelizumab is a prime example of the latter.

    • Yes but look at the patient’s prior DMT history. The event occurred after exposure to multiple DMTs including Tysabri. These risks haven’t been realised for patients who were treatment naive prior to receiving their first course of Ocrevus. Tysabri appears to increase the risk of PML with this drug. What i’d like to know is how soon after their last Tysabri dose did they start Ocrevus and whether it’s possible that PML could have occurred irrespective of the subsequent DMT exposure.

      Prof G’s post only gives us a part of the picture.

  • How long after stopping either natalizumab or fingolimod did these people start ocrelizumab and then how long before they presented with PML?

  • Is going ocrelizumab (or any anti-cd20) considered anyhow more risky then doing it straight without any prior treatment”?

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