PML Found in Ocrevus-Treated Patient Who Had Used Tysabri for 3 Previous Years

PML Found in Ocrevus-Treated Patient Who Had Used Tysabri for 3 Previous Years

A multiple sclerosis (MS) patient treated in Germany with Ocrevus (ocrelizumab) has developed the dreaded brain infection progressive multifocal leukoencephalopathy (PML). But it is not clear whether the recently approved Genentech/Roche-developed treatment is the cause.

The patient took the last dose of a three-year course of Tysabri (natalizumab) in February. Tysabri is a known trigger of PML — a severe brain infection caused by the John Cunningham (JC) virus, which leaves the majority of patients severely disabled or causes their death.

In April, the patient received one dose of Ocrevus as part of a German compassionate-use program. The person has not been otherwise identified.

According to Anthony Vaughn, international communications leader, multiple sclerosis, at Roche, the company is investigating the case. An email statement he gave to Multiple Sclerosis News Today said the patient tested positive for JC virus infection, but did not specify if the testing was performed before or after the Ocrevus infusion.

The patient’s treating physician has reported the PML case as a carry-over from Tysabri, according to the Roche statement.

An opportunistic microbe, the PML-causing JC virus is not harmful to people with an intact immune response, but many MS treatments are immunosuppressive. Several therapies that target T-cells have been linked to PML. Ocrevus does not directly act on T-cells, but its close cousin Rituxan (rituximab) — which like Ocrevus targets CD20 B-cells — has also been associated with this aggressive brain disease.

No patient developed PML during Ocrevus’ extensive clinical trials. But this fact is no guarantee that the condition will not appear as more patients receive the treatment. PML is a rare complication, and was not discovered in Tysabri-treated patients until the drug gained market approval.

The prescription label of Ocrevus includes a note about a possible PML risk, but that warning is largely thought to be an FDA precaution. Tysabri’s label, in comparison, now includes a much stronger notice of risk, called a black-box warning.

Genentech and its parent company, Roche, have kept a close eye on this possibility, with several currently running clinical trials aiming to explore the long-term safety of Ocrevus.

“Patient safety is Roche’s highest priority and we are gathering more details about the case and the patient’s history. We will continue to share information with healthcare providers and global health authorities as we know more,” Roche said in its statement.

Patrícia holds her PhD in Medical Microbiology and Infectious Diseases from the Leiden University Medical Center in Leiden, The Netherlands. She has studied Applied Biology at Universidade do Minho and was a postdoctoral research fellow at Instituto de Medicina Molecular in Lisbon, Portugal. Her work has been focused on molecular genetic traits of infectious agents such as viruses and parasites.
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Patrícia holds her PhD in Medical Microbiology and Infectious Diseases from the Leiden University Medical Center in Leiden, The Netherlands. She has studied Applied Biology at Universidade do Minho and was a postdoctoral research fellow at Instituto de Medicina Molecular in Lisbon, Portugal. Her work has been focused on molecular genetic traits of infectious agents such as viruses and parasites.
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17 comments

  1. There are a lot of unknowns here, as the full details of this case are yet to be revealed. Some MS patients who test JCV Ab positive without being on Tysabri, for instance, are these patients at risk as well for PML if they start Ocrevus ? This throws a wrench into the works.

    Obviously, till the air is cleared, ALL TYSABRI patients coming off the drug owing to JCV Ab positive status will NOT possibly be given Ocrevus, period. Whichever way it goes, it is remarkable that ONE single infusion (300 mg) of Ocrevus triggered PML. It only shows how little we know about why patients get PML, particularly with switching of MS drugs or even when a drug such as Tysabri is administered. There are significant gaps and risks involved with drugs now being used in the MS world and risk assessment, stratification and long-term goals need to be clearly understood and defined.

  2. Eric Woodard says:

    So does this mean that if you were using tysabri for 3 yrs or more if you switch to ocrevous you will have PML in your body so it is not recommanded to switch.

  3. Tracy Shudo says:

    I totally agree with the comment above. I was on the final trial study for Tysabri. I went from 3 to 4 attacks a year to on the first 24 months 1 mild one. Then the issue with PML happened. The study I was on came unblended to see who was on medication. We all were, then there was 18 months where there was no treatment. During that time I had 3very bad attacks, one attacked my brain stem. When Tysabri came back the study went from a 3 year study to a 10 year study. I am JCV positive. But as far as I am concerned the quality of life that Tysabri has given me in the last 14 years cant be touched. I am going into 2nd progressive MS. but I have been diagnosed for 22 years. So walking is becoming a challenge. Over all I am personally concerned about mixing / changing up very strong MS treatments. I know not all work for everyone, I was thinking about changing my treatment but the more I read on how people that have had more than one kind of medication those people are getting a PML. So I am again thinking I will not be changing medication. Good luck to us all who are fighting this condition.

    • Charlie Rose says:

      I do a lot of reading and reviewing, I have been on Tysabri about 13 years plus. Before Tysabri, I was on copaxone, bad reaction, went to betaseron, allergic reaction – hives; went to tysabri and in between that period, I took tecfidera, about 3 months, awful, got off right away. Friday, I went off Tysabri to Ocrevus. I’m hoping for a good outcome. My JC Virus count has been climbing slowly, I don’t feel exactly right, it is time to move. The outcome of this little update is, each decision is mine, not carelessly take, not without good support and advice but each individual personally has to decide what is right for them. Try to read everything, think what is right for you, and pray, and pray, God will guide you on your path.

  4. JOYCE CERVENKA says:

    I have been on Tekfidara for 3years, another T-cell inhibitor, and am thinking of going on Ocrevus, but have thought that now both my T and B cells might be too low, and I could get pml or some other disease.

  5. Kelly Fassino says:

    This is very upsetting. I was just tested positive for JC in March after being on Tysabri for 11 months. I read about this drug a couple of weeks ago when I found out about my JC status and was hopeful. Now, not so much. My doc wants me to stay on Tysabri for another year, but I’m not comfortable with that. The risk of getting PML are too high and I’d rather not take the chance.

    • Alicia Wade says:

      Please get a second/third opinion, until you are comfortable with your
      decision. It still boggles my mind how different neurologists still have different opinions on how to treat MS patients and with which drugs! It is confusing for MS patients. Do what your gut tells you to do.

    • Daryl Melancon says:

      I have been on Tysabri for over 10 years just took my 130th infusion and yes I have tested positive the last 4 times they have tested it and had some faulse positives a few times in the past dont get to nervous yet.

    • Jan Lucas says:

      I wouldn’t risk another year. I was on Tysabri for 2 years, and got off it because that was about when people began contracting PML. I later tested positive for JC. I wouldn’t risk it. I am now only on the compounded LDN, and I’ve not progressed at all. I first got it through a naturopath. Since then, my neurologist prescribes it, since I’ve done so well on it. Since it is compounded, and, therefore not covered by Medicare, I order it from Belmar Pharmacy in Colorado (I live in OR). It is much cheaper there than here.

  6. S. A. Shelby says:

    My daughter took Tysabri for over four years. Periodic tests for JV were negative. She stopped Tysabri and after recommended interval had one infusion of Ocrevus. She was hospitalized after a [first ever] seizure before she could do the second infusion. Tests for JV were still negative until two months later when a brain biopsy was positive the day before she died from PML. It was a horrific two months.

    • Kesia says:

      So so sorry to hear about your daughter 🙁 were they able to confirm if the JV caused it or the Ocrevus or tysabri?

  7. Karen Shelly says:

    My niece stopped Tysabri this spring for several months so she could start Ocrevus. Several weeks after her first dose of Ocrevus she was hospitalized after a series of seizures. Within days she experienced dramatic cognitive decline. All of the JCV tests were negative until a brain biopsy the day before she died of PML-IRIS two months later. It was horrible. Ask your doctor about the risk of developing IRIS when stopping Tysabri. This especially important for those who are JCV positive.

  8. Shawn says:

    I’ve been on Betaseron for 8+ years. Just had test for JCV my test was positive. My neurologist wants me to go on Ocrevus. Now I am really giving it a second thought.

  9. I have been on Tysabri for 7 yrs and stopped Oct of 2017 as I was seeing after just 2 days of the my infusions I was starting to go downhill a bit as in no energy lack of strength. I have RRMS since I was 21 yrs of age in 1997. I got worse with Avonex and Copaxone and didn’t take anything else after the until 2011 when my neuro convinced me to do it. I felt great in the beginning and actually started to jog again. I felt on top of the world like I was getting my life back. Now I have the decision to make of starting Ocrevous. After seeing all of the positive videos of patients who made the switch I feel its something I should do. I saw a lady walk again from being in a wheel chair for 21 yrs,another who now walks a mile and others who got some energy back,walking better and cognitive issues a lot better as well as some who tested positive with high titer levels that now take it because of that problem. My cousing who works at Geisinger Medical Center here in PA in a neurologists office told me some wonderful things about patients as well and has been studying up on MS for years. She gave me some hope to make the switch being as afraid as I was to do it just like I was afraid of trying Tysabri. All drugs have good and bad outcomes but it’s a chance I have to take. If I don’t like it I will soon stop it. chance I feel I have to take.

    • Holly LeCocq says:

      I’ve been on Tyrabri for 8 years, My RRMS has changed from being more progressive.I started with using a cane to a a year ago.walker. I can use my cane,but feel safer using my walker. My neurologist asked if I wouldl like to switch to Ocrevus. She said it’s totally up to me, I decided I would switch without really researching throughly ab the drug. My blood tests all came back good for switching. I’m having second thoughts ab the switch. Reading other people’s thoughts ab the drug makes me scared just like I was with Tyrabri. It’s a new drug ! I’m negative for the JC . So confused!

  10. Ted D. says:

    My neurologist had me stop taking Tecfidera earlier this month after being on it 5 years, because my last blood test showed my JCV positive index value rose from 3.2 in January of this year to 3.9 in December. He wants me to start Ocrevus, but having such a high JCV index value is causing me some concern. Am I safe to start Ocrevus considering that I’m JCV positive with a high index value? Thinking of getting a second opinion…

  11. Lynn says:

    I’m going back to Avonex forget about all these new infusions. I had two split doses of ocrevus and I just want my Avonex back!!!! (and all my hair that fell out while on Ocrevus).

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