Ocrevus (Ocrelizumab) - clear doubts about safety
Posted: Wed Jan 11, 2017 5:12 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.
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, donĀ“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
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.
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, donĀ“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