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 case||Country||Reported||Setting||Carry-over from|
|1||Germany||May 2017||Compassionate Use programme||Natalizumab|
Roche are sharing this information for full transparency and hope you find this useful.