So, what is happening with Ocrelizumab ?

[JerryD]

I guess that I am sound ing like a 'broken record' . I am curious about the happenings, recently, with the drug Ocrelizumab . Does anyone have any 'news' ?

[AMJ]

Sounds promising

From MS-UK.org site

Roche drug shows promise for less common form of MS
(09/10/15)
Swiss drugmaker Roche has said its experimental treatment for multiple sclerosis performed better in a late-stage clinical trial than a commonly used therapy for the most prevalent form of the condition.

The drug, ocrelizumab, also showed a benefit in primary-progressive MS, or PPMS, giving it the potential to be the first medicine on the market for those patients.

"For decades, we've tried different medicines to treat the primary progressive forms of the disease and nothing has worked," said Dan O'Day, Roche chief operating officer of Pharmaceuticals.

"Ocrelizumab is the first medicine to show an effect in significantly reducing the progression for patients with progressing multiple sclerosis. We're very excited about the benefit that could bring to patients."

The results were from three studies being presented at the European Committee for Treatment and Research in Multiple Sclerosis meeting in Barcelona.

Roche's ocrelizumab is given by infusion once every six months, significantly less frequently than most other MS medicines. The company compared its drug with Merck KGaA's Rebif, an older therapy administered by shot three times a week.

In two studies in relapsing-remitting MS, ocrelizumab reduced patients' risk of flare-ups by almost half over two years compared with Rebif, Roche said in a statement. It also delayed progression of disability by about 40 per cent and reduced brain lesions by about 80 per cent, Roche said.

The most common side effect was infusion-related reactions.

In PPMS, the less common form, Roche compared ocrelizumab with a placebo given the lack of approved therapies. There the medicine also met study goals, reducing the risk of disability progression over 12 weeks by 24 per cent.

The medicine is Roche's first in multiple sclerosis.

Source: CNBC © 2015 CNBC LLC (09/10/15)

[Seasha]

Here are some links about ocrelizumab from ECTRIMS conference happening right now 10/10/15-

http://msworld.org/conference-center...nd-ocrelizumab

http://msworld.org/conference-center...-trials-update

http://msworld.org/conference-center...-ppms-and-rrms

[COMinx]

I have been in the Oratorio study for the past 3.5 years.

They have unblinded the results and my study coordinator called me with my status earlier today. I have been receiving the drug, which I kind of suspected.

My diagnosis with PPMS occurred in February of 2012. Lucky enough to be diagnosed at a center participating in the Oratorio study, I was enrolled within a few weeks and had my first infusion within a month and a half of diagnosis.

I never had any problems during the infusions or anything I could really call a negative side effect. The only things I have experienced are being *really* hungry on the nights (chalked this up to the steroid administered prior to the drug) after the infusions and changes to my menstrual cycle (sorry if that's TMI).

During this time I haven't had any significant worsening of symptoms or disability. In fact some issues I had with my left leg dragging after walking moderate distances have improved. A couple of times - maybe once a year - I have had outbreaks of what I call the "numb and tinglies". This would be areas of pins and needles shifting all over my body. These generally have gone away after about a day and haven't left behind any permanently impaired areas.

I am really excited about the drug going for approval with the FDA and very much hope that it is approved and quickly. I am pretty convinced that I would be further along in disease progression if I hadn't been receiving the drug for the past few years.

If anyone has any questions regarding my experience in the study I would be happy to answer.

[JerryD]

COMinx, thanks for the response. Your answers are exactly the reason I started this thread. Your response is the first in 4 years that has truly given me hope. I have PPMS, was diagnosed in 2010, and have progressed 'down hill' since then. I wish that I was receiving Ocrelizumab. How is it administered ? Infusion ? What are the risks of negative side effects ? What are the side effects ? What have you found to be the positives ? Have you regained functions ? Which functions ?

[COMinx]

Hi Jerry,

When I was first diagnosed I was lucky in that I didn't have much disability. What I had: some permanent numbness/tingling in portions of my left hand, and the bottoms of the front part of both feet incl. bottoms of toes, some balance issues when my eyes were closed, very occasional dizziness, random leg jerks when lying down, some depression, and for about 8 months I had been having problems with my left leg starting to drag/knee hyper-extend when walking - for example, would need to stop and rest while going to the mall or could only make it half way around the neighborhood instead of the whole way. Very lucky compared to many others.

Out of the above, the only thing that I can say has improved is that my leg doesn't drag anymore when walking unless I really push it or if it's very hot outside. My knee does occasionally still hyper-extend, but not as much as it was. Everything else has stayed the same. Sometimes I am fatigued but I can't tell if this is due to MS or life in general. Heat does seem to have an effect on me though making me more tired and can't walk as far.

It is administered via infusion, with a set of infusions every six months, two weeks apart. So, if I had an infusion today, I would have a second one two weeks from today, then the process would repeat every 6 months thereafter. This is six months counted in weeks. So it's not like every June and December. The months shift based upon the week count.

My visits started with study-related stuff (doc evaluations, testing, blood draw, etc). Once you have your port placed and you're in the chair, they give you some oral anti-histamines and...I think the other pill is an aspirin or tylenol or something along those lines. They start the drip with a steroid. After that finishes they switch out and start the drug. Once the drug is completed you needed to stay for an hour of observation. During this process I always fell asleep for an hour or two - the anti-histamine knocked me out.

This totaled to an all-day event for me with the infusion portion, including the hour of observation, taking roughly 4.5 to 5 hours. If approved, I would think they could maybe get it down to a half a day for the infusion without the study-related stuff and if they cut out the hour of observation - but no idea how it would play out if approved.

I didn't experience any direct negative effects from the infusions - no allergic reactions, no headaches, no infections, etc. The only thing I experienced was getting *very* hungry the night of the infusions. I think that has to do with the administration of the steroid and not the drug. Since I didn't experience any side effects I can't really say what all is possible. I never took anyone with me (though some patients brought a spouse, friend or relative) and always was able to drive myself home.

There was concern that there may be risk for PML (Progressive Multifocal Leukoencephalopathy) but no one in the study contracted this per the findings released last week at ECTRIMS. To start the study you did need to be tested for the JC virus and I am pretty sure you weren't eligible to participate if you tested positive**. If you want info on PML there are quite a few websites that discuss it if you do a web search.

As far as negatives - I can't think of any in my personal case. There are always chances of side effects cropping up or opportunistic infections I suppose... The findings released at ECTRIMS indicated that there was a higher incidence of cancers in the drug group (11) vs. placebo group (2). I do have some concern about this and intend to watch for additional info as it develops.

But for me, the big positive - and what outweighs current negatives - is: nothing has gotten worse. Since I am quite fortunate to have had mild permanent effects due to MS to date, living in my current state is good to me.

I feel very privileged to have been given the opportunity to participate in the study and have the highest hopes and best wishes that fellow PPMS - and RRMS but particularly PPMS - folks will also be able to benefit soon!

** - I just looked at the study exclusion criteria and it doesn't specifically mention the JC virus so not sure if I am remembering correctly. It does say: "- Known active infection or history of or presence of recurrent or chronic infection" from http://uhealthsystem.com/clinical-tr.../details/15264