Patient with MS was previously treated for 3 years with natalizumab, a known trigger of progressive multifocal leukoencephalopathy.
A patient with multiple sclerosis (MS) who was treated with ocrelizumab (Ocrevus) has developed progressive multifocal leukoencephalopathy (PML); however, it remains unclear whether ocrelizumab is the cause, according to a report in Multiple Sclerosis News Today.
PML is a severe brain infection caused by the John Cunningham (JC) virus, which results in death or most patients becoming severely disabled.
The Germany-based patient received natalizumab (Tysabri)—–a known trigger of PML––over a 3-year period, with his final dose administered in February 2017.
In April, the patient received 1 dose of ocrelizumab as part of a German compassionate-use program, according to Multiple Sclerosis News Today.
In an emailed statement, Anthony Vaugh, international communications leader for Roche, told Multiple Sclerosis News Today that the patient tested positive for JC, but did not specify if the testing was performed before or after the ocrelizumab infusion.
Roche said the patient’s treating physician reported the PML case as a carry-over from natalizumab. The company is currently investigating the case, according to the report.
During extensive ocrelizumab clinical trials, none of the participants developed PML; however, Roche has not dismissed the possibility of PML developing and currently has several running clinical trials to examine the long-term safety of ocrelizumab, according to the report.
“Patient safety is Roche’s highest priority and we are gathering more details about the case and the patient’s history,” Roche told Multiple Sclerosis News Today. “We will continue to share information with health care providers and global health authorities as we know more.”
Ocrelizumab was granted FDA approval in March to treat relapsing and primary progressive forms of MS. Although its prescription label does include a note about the potential risk of PML, the warning is largely thought to be an FDA precaution, according to Multiple Sclerosis News Today.
However, natalizumab’s prescription label now includes a black-box warning.