New drug reduces progression for primary progressive MS....

Discuss Ocrelizumab, a monoclonal antibody treatment for MS.

New drug reduces progression for primary progressive MS....

Postby MSUK » Mon Sep 28, 2015 8:40 am

Study finds new drug reduces progression for primary progressive MS patients

Genentech, a member of the Roche Group, has announced positive results from a pivotal Phase III study that evaluated ocrelizumab in people with primary progressive multiple sclerosis (PPMS). The study (ORATORIO) met its primary endpoint, showing treatment with ocrelizumab significantly reduced the progression of clinical disability sustained for at least 12 weeks compared with placebo, as measured by the Expanded Disability Status Scale (EDSS)... Read More - http://www.ms-uk.org/ocrelizumab
MS-UK - http://www.ms-uk.org/
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Re: New drug reduces progression for primary progressive MS.

Postby MSbro » Wed Sep 30, 2015 6:26 am

Isn't this drug similar to the type of drug that Tysabri belongs? And the safety results were taken over a 12 week period which hardly qualifies for anything!

I sure hope they do their homework a lot better than what happened with Tysabri before they ever release this medication.
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Re: New drug reduces progression for primary progressive MS.

Postby 1eye » Wed Sep 30, 2015 7:42 am

It is a "mab" drug, or monoclonal antibody. I don't know what the "lizu" part stands for, but it may be another in a long series of mabs that kill immune cells. They are also notoriously expensive, so it is likely to be another in a series of MS drugs that cost upwards of $50,000 per year. It was started with copaxone, which was the first "disease modifying" treatment to have any affect at all in MS. Especially the newly diagnosed are easy prey for this kind of usury. If, like I have, you have lived with your diagnosis for 18 years or more, you are naturally more skeptical.

I am on biotin 300 mg per day. That was the first "drug" to affect progressive MS, and it lasts for more than 12 weeks. I believe its effects are probably cumulative, in other words, you might just keep getting better. These mab vendors will not promise you that: only a halt to progression for up to 12 weeks.

Roche's study is described in their news release http://www.roche.com/media/store/releases/med-cor-2011-10-20.htm, but our friends at MS-UK also just published an article about a study http://www.ncbi.nlm.nih.gov/pubmed/26359291 that questions the value of a 12-week result as far as confirmed progression is concerned. The Roche study is expected to continue for 5 years. So, like announcements of the death of CCSVI, this announcement about the stopping of progression may be premature, and like the news of Mark Twain`s death, it has been greatly exaggerated. :wink:

I underline the term CCSVI because this particular acronym is used to denote both the procedure and the condition. I think it is a mistake, though understandable, to use it to denote the procedure.
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Re: New drug reduces progression for primary progressive MS.

Postby MSbro » Wed Sep 30, 2015 8:47 pm

Sure sounds like a money grab! Some things don't seem to change in the world of MS medications!!
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Re: New drug reduces progression for primary progressive MS.

Postby EricDrake » Wed Sep 30, 2015 11:36 pm

MSbro wrote:Isn't this drug similar to the type of drug that Tysabri belongs? And the safety results were taken over a 12 week period which hardly qualifies for anything!

I sure hope they do their homework a lot better than what happened with Tysabri before they ever release this medication.


If you check the studies: https://clinicaltrials.gov/show/NCT01194570 you can see that it was not tested over 12 week but for two years initially and were/are continued for additional 5 year for those it seemed to help (since the study started in ~2011 I think some people are taking it for much longer now than 2 years) for ~2500 person and was also tested previously for 96 weeks (1.5 years) in phase 2 study. Of course they want to make a lot of money from that but it doesnt mean that it could not work, I think we should wait for the official results before any conclusion.
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Re: New drug reduces progression for primary progressive MS.

Postby scotland » Thu Oct 01, 2015 4:15 pm

It will be interesting to see what other announcements this might prompt from other companies on their progress and products. I think companies will stick with their proven, slower, race car until somebody brings something newer and faster to the track. Hopefully this offers more hope for us, and we do not have to wait too long to find out, thankfully.
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Re: New drug reduces progression for primary progressive MS.

Postby cheerleader » Thu Oct 01, 2015 7:31 pm

Two other trials for ocrelizumab were discontinued in phase III---due to serious infections and related deaths. There was nothing mentioning this fact in the press.

There were 6 deaths associated with infections in the RA phase III trial. This was at 52 weeks---much longer than the 12 week trial for MS
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3911947/
There were 5 deaths associated with serious infections in the Lupus phase III trial. This was at 48 weeks---again, much longer.
http://www.ncbi.nlm.nih.gov/pubmed/23740801

We know one person with MS died due to inflammatory response syndrome in 2010---how many more since? http://www.fiercebiotech.com/story/pati ... 2010-10-18

MSBro is absolutely right---12 weeks is nothing.
Just what is acceptable risk for people with MS? Shouldn't they be told the risks?
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Re: New drug reduces progression for primary progressive MS.

Postby EricDrake » Thu Oct 01, 2015 11:13 pm

cheerleader wrote:MSBro is absolutely right---12 weeks is nothing.
Just what is acceptable risk for people with MS? Shouldn't they be told the risks?
cheer


Seriously have you even read the artice or what I have written, it was not tested for 12 weeks. Please read before commenting stuff like that....
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Re: New drug reduces progression for primary progressive MS.

Postby cheerleader » Fri Oct 02, 2015 9:08 am

Why are they only touting 12 weeks in the ORATORIO study, then?
I didn't make up that number, Eric...it's in the press release at the top of the page.
If this drug is so fabulous and has a great safety profile in MS, and they've been following patients for years....wouldn't they be saying that to the press?
They picked the 12 week number to publicize. Will have to wait to read the full paper on phase III.
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Re: New drug reduces progression for primary progressive MS.

Postby CureOrBust » Fri Oct 02, 2015 6:47 pm

cheerleader wrote:Why are they only touting 12 weeks in the ORATORIO study, then?
I didn't make up that number, Eric...it's in the press release at the top of the page.
If this drug is so fabulous and has a great safety profile in MS, and they've been following patients for years....wouldn't they be saying that to the press?
They picked the 12 week number to publicize. Will have to wait to read the full paper on phase III.
I have not read any of the links, but as soon as you hit "publicize" you MAY be introducing the mistakes of a single reporter.
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Re: New drug reduces progression for primary progressive MS.

Postby MSbro » Sat Oct 03, 2015 2:27 pm

The stories surrounding this new drug sure look similar to what happened with Tysabri. I can remember reading that this drug was going to be "the" answer to MS. All the hype around it was incredible! Then it was pulled from the market and allowed back, supposedly partly due to some patients pleading with the FDA to give it their blessing again.

Well it came back and look at the number of reported PML cases...588. And that doesn't include unreported PML incidents along with all the other serious infections that pop up.

I really hope this new drug doesn't follow the same path because all it will do in the long run is make the company who makes it very rich.
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Re: New drug reduces progression for primary progressive MS.

Postby cheerleader » Sat Oct 03, 2015 6:09 pm

CureOrBust wrote: I have not read any of the links, but as soon as you hit "publicize" you MAY be introducing the mistakes of a single reporter.

It was in the press release from Roche---please note, the ORATORIO study is in PPMS.
The primary endpoint of the ORATORIO study was time to onset of confirmed disability progression (CDP), defined as an increase in EDSS that is sustained for at least 12 weeks.
http://www.roche.com/media/store/releases/med-cor-2015-09-28b.htm
Here are the phase 2 results in 220 patients with RRMS-
One patient in the ocrelizumab 1000 mg group experienced an SAE (breast cancer) during the safety follow-up period that was judged by the investigator to be probably related to treatment.
In addition, one patient receiving the ocrelizumab 1000 mg regimen died at Week 14 as a consequence of complicated systemic inflammatory response syndrome (a causal relationship with OCR cannot be ruled out) (Table 1).
http://www.adelphigroup.com/acl/11-10-12/poster1.pdf
Really important to note that the phase III trials in RA and lupus, which had 11 deaths and many more infections, were also 10x larger and involved more patients receiving the drug-- 2000 patients vs. 200 and followed patients for much longer--4 years.
That's why the drug was pulled and not marketed to these patients. It was deemed too dangerous. And they've tried it on people with arthritis, lupus and RA---and it was pulled for all of these conditions, due to risk of death. (They'll have to change the name before selling it to pwMS. 8O )
Drug company Biogen (BIIB), along with Roche Holdings, announced Monday the suspension of a testing program for the arthritis drug ocrelizumab due to safety concerns.
The Data and Safety Monitoring Board recommended the suspension once several cases of infections led to deaths.The suspension of the drug may damage its long-term marketing potential once an approval is made.
The most recent suspension is not the first time ocrelizumab testing was stopped; the drug was also pulled from testing for treatment of lupus and rheumatoid arthritis last year.
http://www.foxbusiness.com/markets/2010 ... g-testing/
The implication is that once this drug is out on the MS market, and more patients use it for longer, the rates of adverse events will rise...just like Tysabri.

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Re: New drug reduces progression for primary progressive MS.

Postby MSbro » Sun Oct 04, 2015 6:10 am

The Data and Safety Monitoring Board recommended the suspension once several cases of infections led to deaths.The suspension of the drug may damage its long-term marketing potential once an approval is made.
The most recent suspension is not the first time ocrelizumab testing was stopped; the drug was also pulled from testing for treatment of lupus and rheumatoid arthritis last year.
http://www.foxbusiness.com/markets/2010 ... g-testing/
The implication is that once this drug is out on the MS market, and more patients use it for longer, the rates of adverse events will rise...just like Tysabri.


Concern over the long-term marketing potential for a drug that could follow the same path as Tysabri!!! Why do I feel that more emphasis is being placed on corporate profit rather than on the health of MS patients?
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Re: New drug reduces progression for primary progressive MS.

Postby 1eye » Sun Oct 04, 2015 1:19 pm

These are monoclonal antibodies, which selectively kill immune cells, including those which have "memory". They "remember" and are programmed by, for example, childhood infections with chicken pox. After these "mabs" are used, the immune system is left in a vulnerable state, which can allow adult infections with, for example chicken pox, which in adults, is shingles.

The shingles immunization uses live virus. Therefore it is extremely dangerous to do this immunization when you are in this vulnerable state, where chicken-pox-aware immune cells have been selectively wiped out.

However, if you have already had shingles, and have not had "mabs", you may be producing enough shingles-specific antibodies, that the use of the zoster, or shingles immunization, may allow you to better combat future shingles infections.

There are problems with 'antegren' which involve infection with PML, or jc virus. This may not be a problem with this new "mab", but it is a door which for various reasons, you may not want to go through.

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Re: New drug reduces progression for primary progressive MS.

Postby MSbro » Sun Oct 04, 2015 3:59 pm

There are problems with 'antegren' which involve infection with PML, or jc virus. This may not be a problem with this new "mab", but it is a door which for various reasons, you may not want to go through.

I am not a doctor.


Every "mab" that I have read about seems to be associated with a high risk of infections, up to and including PML. And if you stop taking the "mab", as in the case of Tysabri, there are additional problems that occur. Like you said, it's a door you may not want to go through!
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