Newer medication or trusted older one

Question

When I went to see my Neuro she gave me some information on two different medications and I am having a hard time deciding on what rout to take. T

#1 Copaxone - a trusted med that has been around for a while. There are reviews of good results. The side effects are known and the long term effect is known as well, oh and lets not forget that it is an injectible medication. 

#2 Gilenya - Newer med, long term effect not known. My Neuro currently has a clinical trial that she said would like me to get into which includes this med. I would get the testing and meds paid for as long as I was in the trial. Problem is that there are two other meds that are given in a control setting. I'm concerned with how new this one is when compared to the others

Does anyone have any information on this they would like to share. 

Thank you
Candy

immisceo · Accepted Answer

WARNING: War and Peace-length Post Incoming!

DMD = disease modifying drug. Sometimes you'll also see DMT = Disease modifying treatment. Both terms mean the same things. Any medication specifically for MS falls under this heading, because that's what they do. They don't cure it, they don't stop a relapse in its tracks, they don't treat your symptoms. They modify the disease process and (hopefully) your disease course by slowing down the rate of damage to your central nervous system. They play the long game, so to speak.

I'm interested that your neurologist mentioned wanting to treat this aggressively as possible, but then mentioned two standard first-line drugs. Are the other two drugs in the Gilenya trial investigational? (licenced for trial, but not on the market yet).

Your diagnosis story is similar to mine. Perfectly healthy at thirty, then three successive clinically, objectively observable incidents and an MRI that lit up like Vegas, and I got my diagnosis within 5 weeks of the first hint of a problem. 

If you're feeling a bit overwhelmed, perhaps it's a good thing that you're just choosing between two. But for the record, there are several other DMDs you could also get at this point. Sometimes we have to be a little, er, out-spoken with our neuros. My point is, treatment is better than no treatment, but it's a personal choice. However, if you do find a different DMD sounds more appropriate for you or your more comfortable with, push for it. Almost all of us in this forum have had some sort of self-advocacy crash courses in this!

Side-effects can seem scary, and you're right to look at both of these drugs critically, but for me MS was scarier. A lot scarier. Perhaps look at more mundane aspects of them too. DMDs are a long term (life-long at this point in the game) commitment. Most of us will switch a couple of times, but I went into it thinking, "which of these do I feel I can take for rest of my life, and comply faithfully?" For me, that narrowed things. 

I could never have attempted Copaxone, myself. Having to medicate daily would just be too much of an interruption. Ditto Gilenya (though it wasn't licensed yet for Europe when I begen). If I hadn't gotten on the trial, I would have gone for Avonex. Once a week, then forget it. This fit with my life, my scatter-brained-ness (I always knew 'the pill' wasn't for me either!), and my desire to marginalise MS in my life as much as possible. So there are plenty of other things to consider besides side effects, though it's perfectly understandable that those are forefront in your mind right now.

But then I went for the trial. You will make the best decision for you, but just to walk you through my thought process my reasons were three fold.

1.The Guidance. My diagnosis was sudden. I knew I'd benefit from the opportunity to have face-to-face contact with the experts on a monthly basis. I needed that intensive hand-hold to start. Three years later I still value that. Knowing that this level of observation and the chance to be on a new drug didn't put anyone, even my insurance company out-of-pocket, was an added bonus.

2. The Gamble. It was a gamble that seemed worthwhile. In the terminology of the trial's screening protocol, I was deemed to have "aggressive RRMS" (two or more relapses in the preceding year, one or more currently enhancing lesion). The oral medications weren't out yet, Tysabri was hardly ever used as a first-line treatment (that's changed a bit), and that left me with the tried a true (but less effective) CRABs drugs—the injectibles Copaxone, Rebif, Avonex, Betaseron. 

The drug being investigated in the trial had better statistics and was already in phase three, meaning it did have years of safety data available to consider. And I had little to lose; it was a double blinded trial, but it was comparative. I was either on one drug or the other. No possibility of placebo only. So I was rolling the dice that I was getting something better than what was otherwise available to me.

3.The Gratitude. Lastly, and I've spoken about this before on here, was the sense of pay-it-forward. I had the luxury of being overwhelmed by options when I was diagnosed. Twenty years ago, those options weren't there. And the fact that we have so many drugs to choose from now (about 10) is the direct result of people volunteering to be on trials and in studies when nothing was guaranteed and no effects were known and no real data was available. And between being overwhelmed by options and being overwhelmed by silence after diagnosis, I know which I'd choose. And I am so grateful to those early day vanguards.

You're at a really, really intense time. I've been there. I lost months to fevered internet research and worry. But it started to calm down once I got into my routine with medication. I'd no idea the weight it would take off my mind to know I was doing SOMETHING, not just abandoning myself to this unpredictable disease. It gave me a sense of agency. And that was my turning point. That, plus time. This will settle down into your new normal. I promise.

essdipity · Answer

Gilenya has been on the market for quite a while now, at least in the US. I believe there are some but not many members here who take it.

I'm not quite sure I understand your dilemma, so let me repeat what I think you're saying: Your doctor is asking you to choose either Copaxone as a regular patient or to be in a drug trial. There are 3 meds in the trial, one being Gilenya, and you don't know which of the 3 you'd be assigned to, nor will they tell you which one it is. Is this correct? Do you know how long the trial would last?

Some others above have given you the pros and cons of a drug trial (which I've never done). The most compelling pro, to me, is that you would be given much more attention and monitoring during a trial than you would likely get just taking a DMT. That can be very useful. If it seems you are having problems and getting worse, they are right there to either change the situation or dismiss you from the trial. I would find that very reassuring.

But I too would like to know why Gilenya is in the mix to begin with, and I'd ask that question before making any decision.

This whole question is one that only you can decide, of course, but if you should decide against the trial, I suggest you ask your neuro why your only other choice then would be Copaxone. Nothing against that, but it's not for everyone, and everyone is different. I'd want to be able to choose from all the standard 'older' drugs, and also Tecfidera. And maybe Gilenya too, outside the trial, so you'd be sure that's what you're getting.

In any event, please rest assured that there's no reason whatever to be terrified to start any MS drug. Once you do, you'll actually be fighting back at the MS monster, which is important. I urge you to take advantage of treatment that can really work. That option wasn't available in generations past. Also remember that there's nothing written in stone about a particular drug. If you find you can't tolerate one, or your neuro decides it isn't being effective, there are many other choices. That too is a new thing.

Best of luck with this.

ess

immisceo · Answer

Fingolimod (trade name Gilenya) has been approved for over three years, but they may be researching adifferent dosage or formulation or gathering longitudinal data. 

Here are the list of current Gilenya trials registered with the go-to source for active trials. http://www.clinicaltrials.gov/ct2/results?term=fingolimod&recr=Open There are thirty-one currently recruiting involving Fingolimod. 

Studies number 8 and 21 might fit the bill. (Obviously your neurologist will give you the scoop. I just got curious!).

Candykane77 · Answer

Im not completely sure if Gilenya has been approved, I think it has but tge trial is for that one and two others. Maybe they are gathering more info or trying to get another one approved. Either way I have soooo many questions.

Candykane77 · Answer

Thank you. All of this is very overwhelming.  Even though I am a nursing student I feel as though I should have the answers but it'S different because it's me and not a pstient. I know I have been making a list of questions to discuss with my Neuro when I see her next and everything that you and everyone else is helping so much. I will continue to visit this site for suppot/information/and to help others. It's always nice to know that you're not alone.

rendean · Answer

Sorry to hear of diagnosis! Everyone here (diagnosed) has had the same feelings you are experiencing on this roller coaster of emotions and thoughts.

I would be more aggressive with questions for my neuro. Gilyena is more aggressive than Copaxone. As for the trial, it might be a good decision due to the increased surveillance of your health but I would find out what other drugs are involved in the trial.

I know all this information is a lot to digest. Please feel free to come back and ask any questions that you may have. No question is too small to deserve a response. Everyone is here to help!

Take care of yourself,

ren

SarahL2491 · Answer

I thouht Gilynia was already approved, so wondering why the trials?  Does she feel your current med isn't working and WHY?

I'd ask some more questions…………….everyone has given you good advice but then I'm the "why" person when you want to change my place in line!

Candykane77 · Answer

This was very helpful information. Good luck on your trial, 

Thank you
Candy

Candykane77 · Answer

Corriel,

When I was at the Neuro she told me that with the rate of my relapses (from the symptoms that I gave her and the time line) she wants to treat this aggressively as possible. I guess that from the information I gave her she felt things could get really bad if we did not do something heavy. 

Also just curious since I'm fairly new to all of this....what does DMD mean?

Corriel · Answer

I was terrified at the prospect of starting a DMD. My neuro listedthem all, told me to pick one and meet him a month later.

He only gave me the first level treatment options so that helped but the low effectiveness seemed like it might not be worth trying any of them.

I have wondered about Gilenya just because I had 3 relapses in my first year but since I was advised my neuro is not agresive with treatment I need to be fully armed with info to even bring it up.

It is a tough decision for you though. My only concern with G was its effectiveness and effects over the long term.

Go with your instincts based on any reliable info you can find.  Good luck with your choice.

Corrie

Candykane77 · Answer

Thank you for the input. I know that all of this is really scary. I know from the reading that the Copaxone is an older med with good benefits but the Gilenya is newer with better benefits. The side effects scare me with everything. With everything that I have been researching and the medical knowledge that I have obtained from school....well I'm terrified. Part of the time I think that maybe I should just wait it out and see what happens without treatment but then again I know that this would be foolish just like jumping into a med without knowing everything. My brother is a pharmacist and is able to give me all types of information but that is broad and I will not know exactly what will happen until trying it. 

There really was not any narrowing down process. She gave me information on these two meds and asked me to look over them. As for the clinical trial there are three meds that would be given. It is a controlled trial so I would not know which one I would be getting which raises a lot of other concerns. 

Was anyone else as scared as I am in the beginning or even now years later? All this has happened so quickly. Less then 2 months ago I was being seen for Optic Neuritis and now I have a diagnosis waiting and a decision to make. I've never had any medical problems except for the back surgery that I had a few years back caused by ruptured disks, I've always been healthy and now I feel as though the world has crashed and I have to put the pieces back together. I'm sure all of you have felt this way at some point. 

Anyway back to the topic....thank you for the info and yes you are right weighing the negative is high priority.

candy158 · Answer

Hi, I used Copaxone for 1 1/2 years and I was taken off it because of the damage it was doing to my skin.  It was atrophy all over the place .   I have big huge holes in my skin, and my legs look awful now.  I have never been that proud of them anyways, but now I can't show them without knowing if I will be stared it. 

I am now on Anonex and have been for 2 months as well, I like it better than the Copaxone because the pen is already loaded and it doesn't leave huge welts and bumps all over your body.  It isn't sore either, but, there is side effects from it as well, the flu like symptons are pretty common, and I have those for the day that I do the shot, which is only 1 x per week, instead of everyday with Copaxone. 

Hope this helps, 
Candy

TLC_31 · Answer

Of course, there are other DMDs besides those two. To evaluate the final two, it might help to know how you and/or the neurologist narrowed it to those two in the first place. Also remember that although you want to give any medication a fair chance and not switch on a whim, your selection is not a lifetime choice or even a one-year contract, .

Copaxone and the injectible interferons certainly have stood the test of time. The potential side effects and efficacy of those medications are known, but they can vary significantly among patients. Because I’ve never used Copaxone, I can’t intelligently address its specific side effects. I suggest that with any drug you assume your side effects will be fairly intense and make sure you will be able to manage with them. Likely you’ll be pleasantly surprised that they’re not as intense as you’d planned.

I have used Gilenya … for 19 days. I’ve seen reports that many other people have used it with success, but for me the side effects were prohibitive. As a result, I’m biased toward the older drugs, especially starting out as you are. Use the drug that you can best manage any side effects and maintain the required dosing routine. Missing shots or pills frequently negates the entire purpose of taking the drug.

A clinical trial is a great way to ensure the doctors pay attention to you. You might not know what drug you’re on (I would hope you’d at least be on one of them), but if you can handle each of the drugs that it might be, you really can test-drive a drug and serve the broader MS community in the process.

immisceo · Answer

Here's some feedback from our community members who use or have experiences with Copaxone. 

http://www.medhelp.org/posts/Multiple-Sclerosis/Copaxone-Users/show/1648777

and http://www.medhelp.org/posts/Multiple-Sclerosis/Copaxone-users---past-and-present/show/643683

Ditto Gilenya users. 
http://www.medhelp.org/posts/Multiple-Sclerosis/Gilenya-Users-Past-and-Present/show/1469412

I've never used either, but having weighed the risk/benefit ratio in my own mind when deciding to participate in the drug trial I'm on (the drug isn't on the market yet, so even less safety data), I know exactly what it's like to be having these big decisions to make.

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