can someone answer a Gilennya question?

[shel67]

So doc will put me on Gilennya if I want. He's setting up blood work for all the oral meds. My question is what is the PML risk for this one. I know its lower then Tysabri but how or do they even monitor you for it? Also, what kind of side effects or experience have you had?

Thank You.

[shel67]

Black holes... Lesions. She (the neuro MS specialist) wouldn't go into much detail but was honest when I asked if there was permanent damage and there is. She was educating the resident doctor explaining to her how to check for black holes and one on the left side of brain was "deep" is what I heard her say. There were small black holes on the right side as well but apparently the left one was the more serious one I guess as far as damage goes.

She stated she was focused on not having the lesions becoming permanent damage. That's how I understood her. Of course I'm not in my right mind but my husband took it that way too.

She told me to let her worry about that (stuff on the MRI) and just take my meds and leave the rest to her. And she said not to worry, it'll be alright. Poor little resident neuro, I think was really over her head... She got a crash course in MS. Anyway.... the specialist, when I asked her, symptoms may or may not imporove or go away.

I have no idea what's permantly damage as I can still move everything, do everything, its just ackward and a little difficut at times and I have imbalance, brain fog, weird  eyes,  and bad days (for some reason today was a really good day in a long while, hope and pray this lasts). So I don't know what's permanent, I hope all of this isn't. Today things felt better, so who knows?

So based on black holes and permanent damage and lesions I'd say its progessing. Especially seeing how my relapses were NEVER like this in the past, symptoms were mild and singular, not all over like now, and they fully went away. No disability, nothing interfered with life but apparently this thing turned left out of the blue. I woke up a shell of my former self and nothing went way. I know  now it's been doing damage silently. I wish I could have gotten ahead of this before black holes. So before I do get really disabled I want a med that gives me a chance. I don't want to try something, see that it didn't work well and then go to the big guns after more damage and disability has been done. I want to get ahead of this.

[doublevision1]

Sorry I haven't read all your posts so forgive me if you've gone over this already, but what is the evidence of your progression?

[shel67]

No, I've seen a  MS specialist in person when I was diagnosed. She wanted to do copaxone first, I said no to shots. She then came back with Aubagio. I was told this is what you'll take. There was no options, this is it and that's it. Her partner is who I'll be seeing but I could not get an appointment until October. Since I do not have insurance and I'm going through teaching hospital clinic, resources are limited therefore next appointment in October. The specialist are good specialist, very well known, so I know I have a quality doctor, its having access to him.

I did contact the clinic and MS society who advocated with the clinic social worker and the doctor did call me and moved my appointment to August 3. So that's good news and he did say he needs to discuss these things in person with me but due to how far away the original appointed was both neurons do not want me to wait that long to do meds. So Aubagio was set up and by the time I saw him I would already be on treatment.

I do think due to the progression they want me on a med sooner then later. The female neuro wants to prevent further damage.

So based on progression I think Ty is my best chance. The partner on the phone agreed perhaps but Ty would take a while to get and it  may be harder to get due to the infusion center cost.  G with the montoring takes longer, So he suggested I go on something he knows I can get sooner then later.

So that's it

[karryon55]

I think you should consider that DMD's take 3 to 6 months to get to a therapeutic level as they are long acting so going onto something like Aubagio and then changing to another fairly rapidly will not be doing you much good.

They have TB testing on drugs like this as a precaution. I am latent TB and have been on some pretty immunosuppressive drugs in my life but I have not had activation of the TB as yet and probably never will.

I would ensure you have made a decision on what DMD suits your lifestyle rather than on what the "possible" side effects may be. I'm not sure why you would consider Tysabri as your first choice because from my knowledge this would be reserved for when other options run out.

As I've said before I've been on Imuran before which is the original form of Aubagio and to be honest I don't recall any side effects worth noting. I think going into anything with the mindset that you are going to have lots of side effects or it's not going to work for you will ensure you will have problems.

I would be looking at all DMD's that your insurance co will cover and that you think is suitable to your lifestyle. I read in one of your questions before that you haven't seen your Neuro but can only speak on the phone or email if I'm correct? Did you actually see your Neuro when they dx you? I know I can email or phone my Neuro but I also physically see my Neuro. I may be confused by what you've said!?!? I just would want to see my Neuro every 6 to 12 months as routine.

Good luck with your decision.

Karry.

[shel67]

... and, ess your right, I do want what's most effective based on my situation. The doc agreed TY may be for me but he expressed difficultly, not with financial assistance for the med but with financial assistance with the  infusion center.  Copaxone, he explained is the safest  one out there and I can have it in two weeks but I feel I need a more effective one and doc sorta agreed but wants me on something quickly and then I can switch when all the paper work is done on another one I chose.

So if Aubagio gets here quick I'll probably begin that one first.

[immisceo]

I think you may have misread ess's statements. The only times she mentions the word adverse in the above very helpful commentary has been

"All of the trial data is compiled and made available for scrutiny, including all adverse happenings as reported by the patient."

and

"If you look at this data and read the commentary, you will find that relatively few of the trial participants experience ANY adverse effects, and that most of these are transient."

I believe she was simply speaking in general terms. Adverse events are the exception, not the rule in all of these drugs. You seem to be letting your disproportionate fears paralyse you.

I am on a drug trial myself, and I know the kind of documentation they make us keep and the amount of testing we undergo. If this drug is ever approved, every sniffle, ache, depressive episode, headache I've had for the last 4 years will be accounted for, regardless of if they had anything to do with the drug itself (and I have no reason to believe any of them did).

A list of side effects does NOT mean "This will likely happen", it means "this may happen, and we're legally required to mention it". Big difference.

[shel67]

ess,

which drug are you referring to that has had little adverse effect?

[Corriel]

I do believe Gilenya has had 2 cases of PML in the last six months although neither was fatal.

Your neuro is doing all of the pre-testing necessary as far as I can tell from your posts.

As for PML I personally do not know uf I am JC positive or not and my oral med, Tec did lower one of my white blood cell counts significantly. My neuro keeps an eye on things with regular blood work which is something all DMDs require.

Good luck with your decision and keep in mind if you are open to trying an injectable DMD they don't take that long to get started. As long as you start something in the next couple of months you haven't done yourself any harm by taking time to make a well-informed decision for yourself and your health.

As ess stated insurance companies may have a different spin on what they will cover especially for a furst time DMD.

Corrie

[essdipity]

As far as I know, Aubagio presents no risk for PML.

For PML to be a consideration, the patient must first be JC positive--that is, must show evidence of this virus in the blood, which a great many people do, but not everyone. In most cases this is entirely harmless and causes no problems. However, if the white blood count of a JC pos. person gets very low, then the virus can become active and cause PML, a very serious, usually fatal, illness.

In rare cases, a JC pos. person on Tysabri will contract PML. Because of this, most often a person who becomes JC pos (which can happen to anyone and has nothing to do with MS), will be taken off Tysabri. All Tysabri patients are monitored for JC and white count status.

In one case only, a person on Tecfidera contracted PML and died. This person,a woman, had been on Tec for several years (during drug trials and afterwards). Her blood, which had been monitored throughout, showed a very low white count consistently. Why she remained om the drug I don't know, but I think this was an outrageous failure by the medical community.

Of all the MS treatment drugs, only Tysabri and the one instance of Tec have shown any association with PML. All of these illnesses could have been prevented.

Personally I'm on Tec. My white count has stayed perfectly normal, and I don't even know my JC status. It's not relevant unless the white cells get into the very low range, which they haven't. And that doesn't happen overnight--it's a slow progression, so monitoring every few months is sufficient. None of the above is relevant to Aubagio, which has its own concerns but not these.

During drug trials, absolutely everything that happens to a person is recorded. He could break a leg, and that would be noted. Does this mean the drug caused the fracture? Of course not, but still this would go in the record. All of the trial data is compiled and made available for scrutiny, including all adverse happenings as reported by the patient. These are compared with the negatives reported by patients (unknowingly) on placebo. Thus strict protocols for scientific investigation are followed precisely.

If you look at this data and read the commentary, you will find that relatively few of the trial participants experience ANY adverse effects, and that most of these are transient. Only a handful go off the drug (including some on placebo) because of negative effects.

What is far more important is how effective the drug is in fighting MS. All of the approved MS drugs show effectiveness well over placebo. *This* is what you should be focusing on. But you are agonizing over minor issues that probably won't even happen to you. If one does and it's intolerable, then you go off the drug and try something else. You need to stop letting your emotions get in the way of rational decision-making and start doing something to fight MS.

I know this sounds harsh, but I've seen a bunch of your posts, all expressing anxiety way disproportionate to the situation. If you are not getting therapeutic help for this, it should be as big a priority as MS treatment, because it is taking over your life. It doesn't have to!

And just by the way, your insurance company may play a big role in what DMD you go on, because some insist on using the older drugs first, mainly because they are (relatively) cheaper, and some won't approve Tysabri unless a less extreme drug has been been shown ineffective for you.

ess