Compare 9 Earlier Cases of PML in MS Patients After Ocrevus Treatments: Those Involved Earlier Tysabri and/or Gilenya Use


(Posted by Tom Lamb at Drug Injury Watch)


Pharmaceutical company Genentech knew about the first monotherapy Ocrevus PML case no later than October 2019, but important details about the subject patient and its ramifications in terms of Ocrevus drug safety just came to light in March 2021. The reasons for this delay in making a significant Ocrevus drug injury report available to the public are not readily available, but one has to wonder what patient-safety consequences there may have been due to this delay (apparently by Genentech).

From this March 19, 2021, Medscape Medical News report, “First Case of PML Associated With Ocrelizumab Monotherapy“, we get the following overview of this Ocrevus PML case:

A 78-year-old man with progressive multiple sclerosis (MS) developed progressive multifocal leukoencephalopathy (PML) after treatment with ocrelizumab (Ocrevus) monotherapy. It is believed to be the first such case.

“Notably, the patient had never been treated with another disease-modifying therapy and did not carry any known predisposing diagnoses,” the authors say.

They note that other cases of PML have been diagnosed in patients after initiation of treatment with [Ocrevus]; however, all of these cases were related to prior use of [Tysabri] or [Gilenya], and [Ocrevus] had been deemed “noncontributory.”

“The take-home message from this case is that we need to gain more knowledge about the safety and efficacy of our immunotherapies in specific populations, such as elderly people with MS,” Asaff Harel, MD, Division of Neuro-Immunology, Lenox Hill Hospital, New York City, and Zucker School of Medicine at Hofstra/Northwell, Uniondale, New York, told Medscape Medical News.

We get some additional information about this Ocrevus PML case from a March 16, 2021, Medpage Today article, “PML Reported in Ocrelizumab-Treated MS Patient“:

This case, first noted by Genentech in October 2019 but with many details lacking, is the only one associated with [Ocrevus] alone. The 78-year-old progressive MS patient had been treated with [Ocrevus] monotherapy for 2 years when he presented with 2 weeks of progressive visual disturbance and confusion. He had right homonymous hemianopia on exam and MRI showed an enlarging non-enhancing left parietal lesion without mass effect.

Cerebrospinal fluid analysis revealed 1,000 copies/mL of JC virus, confirming PML diagnosis…

The primary source for letting the public know about this PML Ocrevus drug injury report is a JAMA Neurology Brief Report item dated March 16, 2021, “Progressive Multifocal Leukoencephalopathy in a Patient With Progressive Multiple Sclerosis Treated With Ocrelizumab Monotherapy“. From the Abstract for that medical journal article we take this excerpt:

Conclusions and Relevance:  In this case report, PML occurrence was likely a result of the immunomodulatory function of [Ocrevus] as well as age-related immunosenescence. This case report emphasizes the importance of a thorough discussion of the risks and benefits of [Ocrevus], especially in patients at higher risk for infections such as elderly patients.

We will continue to monitor this “new” Ocrevus drug safety issue involving PML as well as watch for any explanation from Genentech about an almost one-and-a-half year delay in making a significant Ocrevus drug injury report available to the public. Medical & Legal Information About Drug Side Effects
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