Ocrevus (Ocrelizumab) - clear doubts about safety

Discuss Ocrelizumab, a monoclonal antibody treatment for MS.

Ocrevus (Ocrelizumab) - clear doubts about safety

Postby Cliffhanger » Wed Jan 11, 2017 6:12 pm

Hey all!

Happy new year everyone!

I get right down to the core in my post.

Ocrevus will soon probably be approved by to FDA. But how will FDA view the risks with this heavily immunosupressive agent ? Becuase there are clear risks that the sponsor Roche and it marketing division are not so happy to talk about. I hope it would be a restricted use, and a clear safety label, so all are aware of the risks involved.

FOR SOME REASON, many tends to underestimate the risks with Ocrelizumab ( Ocrevus ) - it is far to much blue sky (sorry) opinions aired about this, to my view, risky MS-agent.

APART FROM ALL these cancer ( malignancies ) cases in the ORATORIO / PPMS trial (2.3% vs 0.8%) and also worrying 6 cases of breast cancer vs 0 in placebo - if you include the RRMS trial (Opera I/Opera II), it would be good to look at the history of this Ocrelizumab - its footprints in the past.


OCRELIZUMAB WAS HALTED in 2009/2010 both in Lupus and in RA due to several fatal deaths. It is by the way, very little talk about this in the context of the hype around, at least among some, Ocrelizumab in MS (rrms and ppms) ... I wonder why this silence as to previous safety footprints with ocrelizumab ( Ocrevus ) ...(?!)


THERE WERE 6 DEATHS associated with infections in the RA phase III trial.
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3911947/

FURTHERMORE, THERE WERE 5 DEATHS associated with serious infections in the Lupus phase III trial.
http://onlinelibrary.wiley.com/doi/10.1 ... 38037/full

Both studies were halted due to these deaths using Ocrelizumab.


ON OF THE FEW that really highlights the high risks with this Ocrelizumab is this professor Mark Freedman, who, for instance, did this statement at an interview at Ectrims 2015 - he starts talking about Ocrelizumab at the 3:50 mark of the video.

https://www.youtube.com/watch?v=EzM1NbZ ... e=youtu.be


MY POINT:
Given Ocrelizumabs history, I think it is about time to acknowledge that this agent comes with great risks, given its bad safety footprints both in previous studies in RA and Lupus, and now lastly in MS - referring then firstly to all these malignancies.

Yes it appears to have a good efficacy towards halting relapses, but at what cost ? Roche wants of course to market this agent for a broad patient population to earn money. That is only natural wish for a business company.

But to my opinion, use of Ocrelizumab could only be an option for patients who is willing to take the risks and have highly active MS-disease.

And as professor Mark Freedman states in the above interview, what will happen in the long run when you suppress or deplete the B-cells so heavily as ocrelizumab dose ...?


I JUST WISH THAT we could have a more balanced discussion about risks and benefits. So far, to much of the debate is focused on the positive effects, but not so much is mentioned about Ocrelizumabs (OCREVUS) risks. Safety issues put doubts on the drug , especially with regard to long term use.,

Professor Mark Freedman is one of the few that stands up and air a more balanced view on risks and benefits with regard to this Ocrevus (Ocrelizumab).

And Ocrevus (Ocrelizumkabs) twin-sister drug, Rituximab, has a warning label for the deadly PML. Source for this: https://www.gene.com/download/pdf/ritux ... ribing.pdf .

Now, they are both essentially the same drugs, same mode of action, works exactly the same way. But Roche, who owns Rituximab, don´t want to market Rituzimab towards ms, since it patent will expire soon. Therefore they go for its twin-sister, Ocrelizumab (brand name Ocrevus), with long lasting patent. The drug business is for sure very cynical and dirty business.

As for me, I will struggle with my ms best way i can, but I will never take the risk with Ocrelizumab. Its hiden history is dark and Roche will never put all the cards on the table - to much money. billions USD is involved for that to happen. But I hope for something better to come up for us with ms, hopefully not immunosupressive, with good reasonably good efficacy

Best wishes to you all

C
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Re: Ocrevus (Ocrelizumab) - clear doubts about safety

Postby HUD45 » Thu Jan 12, 2017 8:42 am

Thank you Cliff,

I was really hoping for some better news about ocrelizumab. I am a PPMS er and have been following the progress of the FDA fast track status and the Roshe pharm handling.

Unfortunately, I think you are right....The side effects are too risky for my blood. I was hoping for more anecdotal evidence to convince me as well. No such luck.

I will continue to monitor the progress but I am surely not as enthused as I was 6 months ago.

Thank you for the informative post, maybe we will see some other views here soon.

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Re: Ocrevus (Ocrelizumab) - clear doubts about safety

Postby Jimpsull » Fri Jan 20, 2017 1:33 am

Cliffhanger wrote:
But I hope for something better to come up for us with ms, hopefully not immunosupressive, with good reasonably good efficacy

Best wishes to you all

C


Cliff - your wish came true decades ago. Dr Roy Swank developed a diet / lifestyle that arrested progression of MS. He did over 50 years of research including a study where 200 patients were followed for 34 YEARS. About half remained on his diet. Most of them lead full lives and were still walking at the end of 34 years. Those who did not remain on the diet were bedridden or dead.

Doctors Jelinek (a Swank disciple and also an MS patient) and Wahls (an MS patient with plausible theories on things you SHOULD eat who misses the boat my ignoring Swanks compelling research on saturated fats) are also worth reading.

Unfortunately the AMA and (to a lesser extent) National MS Society are subject to a barrage of propaganda from the deep-pocketed big pharmaceutical industry, so people often don't realize how compelling their research is. We have disease care (especially in the US). We need to focus on caring for our health - then we will have less disease.
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Re: Ocrevus (Ocrelizumab) - clear doubts about safety

Postby deradakov » Fri Nov 10, 2017 9:28 pm

I did my best to find out as much about Ocrevus before taking the two infusions in May. Ocrevus told me I was the 36 person to actually officially start the drug and the first this side of New York. I was told by my neurologist Ocrevus was my last hope to stay mobile, and after each infusion my brain felt like it was being expanding into my skull and I slept sitting up for a week after each infusion. I had an MRI last month and there was no change and I had blood tests and my lymphocyte count dropped. I have to stop the Ocrevus now and wait six months before using any MS medication. The neurologist told me if I had the JC Virus test it would show positive which truly has me concerned in the idea I was not given accurate information before I started Ocrevus. I did find out now people have died taking Ocrevus and I just hope I can maintain mobility and enjoy what life I have left to it's fullest. I have known I had MS now for over 32 years and Ocrevus nay have been the worse decision I have made yet on my medical care.
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Re: Ocrevus (Ocrelizumab) - clear doubts about safety

Postby Zyklon » Sun Nov 12, 2017 2:40 am

In my opinion time makes a drug safe. Ocrevus is something new and promising. 10+ years later for me...
Pain! You made me a, you made me a believer, believer
Pain! You break me down, you build me up, believer, believer
Pain! Oh let the bullets fly, oh let them rain
My life, my love, my drive, it came from... Pain!
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Re: Ocrevus (Ocrelizumab) - clear doubts about safety

Postby orphansparrow » Wed Nov 15, 2017 9:59 pm

deradakov wrote:I did my best to find out as much about Ocrevus before taking the two infusions in May. Ocrevus told me I was the 36 person to actually officially start the drug and the first this side of New York. I was told by my neurologist Ocrevus was my last hope to stay mobile, and after each infusion my brain felt like it was being expanding into my skull and I slept sitting up for a week after each infusion. I had an MRI last month and there was no change and I had blood tests and my lymphocyte count dropped. I have to stop the Ocrevus now and wait six months before using any MS medication. The neurologist told me if I had the JC Virus test it would show positive which truly has me concerned in the idea I was not given accurate information before I started Ocrevus. I did find out now people have died taking Ocrevus and I just hope I can maintain mobility and enjoy what life I have left to it's fullest. I have known I had MS now for over 32 years and Ocrevus nay have been the worse decision I have made yet on my medical care.


Wow. Thank you for sharing your story. My husband has an appointment to have his first infusion tomorrow, but he thinks he is going to cancel. It's hard to make these decisions without any assurance, but we think time might tell. I'm sorry you had to go through this. Are you going to continue taking any MS meds? If so, which one do you think? Thank you.
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Re: Ocrevus (Ocrelizumab) - clear doubts about safety

Postby orphansparrow » Wed Nov 15, 2017 10:01 pm

@Cliffhanger

Thank you so much for this Cliff. I appreciate all the opinions from those who have been living with and studying MS for quite a while. My husband had an appointment for his first infusion tomorrow, but he cancelled and is deciding to wait. It's a tough decision.
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