[alexmom]

I have not posted here in a very long time altho I have much appreciated all the support and information I gained from the members of this group, ESPECIALLY when I was first diagnosed with possible cerebritis or vasculitis and feeling very frightened. Johns Hopkins and U of Maryland still disagree about my final neuro SLE diagnosis but I have been on prednisone, plaquenil and cellcept for the last two years. Since the major flare-up in 2005/2006, with the onset of seizures and psychosis, I have had them controlled with Keppra and the other drugs and the occasional steroid infusions. I have just decided not to worry about the "label" and just know that there is definitely inflammation that is "waxing and waning" that causes problems with balance, visions and sometimes speech.

I have some mild kidney protein even with the cellcept (2 mg) and just today started the BLys clinical trial and that is the primary reason for my post. I'm wondering if anyone else here has been in the study or has considered it or decided against it? I had a mild reaction during the infusion so I think I am getting the drug instead of the placebo, which I won't know since the study is double blind for the 76 weeks. This is phase III and the enrollment is for over 800 worldwide and is about to close any day, depending on the number of people screened who are accepted.

The study parameters insist on positive ANAs TWICE so for those of us with maddening floating ANAs (and I have been one from non-reactive to 1:640) the screening can weed people out. The study only allows 2 chances to draw blood for "re-screening" so there is a high failure rate for admission to the study because of the lab requirements. I know my own rheumie had 12 people who "flunked" over the last year and I was positively shocked that I made it, sure that my ANA would be non-reactive.

The positive thing about the study, other than the possibility of a new drug to help, is clinicians are using THREE different scores to measure pain/inflammation etc...those "subjective" measures that are so difficult to quantify and describe, the Selena SLEDAI, BILAG, and PGA (Physician Global Assessment) so the data gathered from all of these lupus patients will be VERY detailed from BOTH PATIENT AND DOCTOR.

I also had to fill out a very detailed survey about my ability to do things for myself, which was very disheartening and somewhat embarrassing for me personnally, but also a valuable assessment tool for the study.


Anyway, I would love to hear from anyone who is participating in the study. I hope the info I posted is helpful to others. Having been on up to 60 mg of prednisone this past year, I just could not face continuing on that path without looking at some other option.

Also, some one commented about Rituxan and lupus in another thread that may be very old... My rheumie advised against because of the PMD deaths...altho that could also be because of the already neuro complications that I have. I could tell that it was a closed subject as far as he was concerned.

As far as this BLyS trial, I know this drug has been used for other things and have tried on my own to find side effect info and of course can't find it...If anyone sees it, pls lmk. Alternate names, BAFF, Belimumab and I believe APRIL may also be the same drug.

I have committed to myself to take this one step at a time and see how it goes, and if I have difficult side effects that are too much or concerns that cannot be answered that I will withdraw.

Thanks for listening and I look forward to hearing from you.
vickie

 

[Raglet]

I guess some of us are desperate enough to risk the very small death risk with rituxan from PMD. With lupus nibbling away at my brainstem (which controls all internal organs, breathing etc) then I'm happy to take my chances !

Personally I think the allergic reaction I have to rituxan is much more of a problem (severe bronchospasm), and my memory of the PMD issue is that the risk is very small.

But, if I had the chose of one drug that had NO risk of it (and time will tell with the new drug) then of course I would choose the safer one.

Anyway, best of luck for the trial, hope it helps

Raglet

 

[alexmom]

Rituxan Side Effects and apology for Raglet and others

Hi Raglet,

Thanks so much for responding to my post. I am glad that you are getting relief from Rituxan, altho not happy to hear of the brainstem complications

I believe I have a vague remembrance of your trying to get insurance approval for the Rituxan, altho I might be mis-remembering.

I want to apologize if I sounded insensitive about Rituxan...that was certainly not my intent and I should have also stated that the rheum that stated the opinion about Rituxan did so right after the PMD alert was first published which was I think fall 2006?

You've been through so much and if I was facing your challenges and choices, I would probably make the same decision.

I would like to ask you about the bronchospasm side effect you mentioned and how it feels if I may...

When I had my BLyS infusion, I had a tightening in my chest and a bit of shortening of breath...No Pain, no coughing, no throat closing, just a VERY uncomfortable feeling of chest tightening.

They stopped the infusion of course, called the doctor in for a good once over and we continued after about 30 minutes...The feeling came and went for the rest of the evening.

Is the tightening I am describing similar to what you are calling a bronchospasm? I did not know how to describe it to the nurse, having never felt it before...

Thanks

Vickie

 

[Raglet]

hi there

I am likely just feeling very touchy because of all the pred I am on, do don't take any notice of me ! In your shoes I'd be trying the new drug too.

With my rituxan sparks severe asthma attacks which continue for the duration of the treatment.

The first treatment they had to abandon altogether, the second treatment they managed to drip into me very slowly over several days, but the bronchospasm (wheezing/asthma) was terrible. I was on nebulizers the whole time, plus large doses of iv steroids (1000mg a time). Each time I had the treatments it took months for the bronchospasm to settle down, and the second time they did the treatment in the icu as my reaction was so severe. Rituxan really helps me, but I am extremely allergic to it. But then again, i am allergic to mice, which is why I have this problem (the anitbody is half mouse). I look forward to the fully humanised version being available to me, then hopefully I won't have this reaction.

As far as the PMD thing goes - I have a memory of it being said after the alert coming out that there was an increased rate of PMD overall in people with lupus, whether or not they have had rituxan, but this is just memory so I could be wrong. Either way, the risk is pretty low I think and in my case I don't have much choice.

hope the new drug helps you

raglet

 

[alexmom]

for Raglet

thanks so much for writing me back Raglet and for hearing my apology

AND you're not being sensitive because of the prednisone I love that we can communicate via forums like these, but it's also easy to write things and then realize, as I did, that I said something that was insensitive to others.:worried: I'm glad that you said something :wink2:

I'm so sorry that the Rituxan gives you such fits and appreciate you telling me what your experience has been.

I had very mild asthma as a child and I can't imagine being sick with lupus and CNS complications and trying to undergo Rituxan and having a major asthma attack!!!!!

Not to mention the other Rituxan side effects I've heard about from other arthritis acquaintances...

You are a real warrior and I will send healing thoughts to you
vickie

 

[mumsy613]

Hello Raglet
I have a quick question (I think) :blush: How did your CNS symptoms change before and after...say months after...Rituxan? Mine got better for a while, then over a year later after the second round, they went crazy...while completely Bcell depleted. I don't know what to make of it. Drs don't either. I need an LP to look for CNS antibodies that are not found in my blood tests. Symptoms wax and wane (mostly wax)...aphasia, very poor cognition, memory trashed, loss of balance, and occasional feelings of just being "in space". Any ideas? I wonder if Rituxan is not the complete wonder drug for CNS...blood / brain barrier issues? Lots of questions.

Thanks, Fran

 

[mumsy613]

I am sorry to have jumped in on your thread....I thought about it a split second after hitting enter. Hope your trial works out well and will be looking for a new treatment!

Best wishes, Fran

 

[alexmom]

rituxin follow-up

I would also be glad to hear more about Rituxin results...I just got the Alert today on Cellcept and PML See the Rheumie on Friday and don' really want to do something different...Had an emergency heart catherization since my last post:rotfl: quite an experience being airlifted to another hospital, but all is now well...

At least the good knews now is I know that the blockages are taken care of and I didn't have time to fret about it.

Gotta keep laughing to keep from screaming!!

So anyone with ideas info from their docs on Cellcept new warning this month, please lmk
Vickie [email protected]

 

[Zoi]

Hey there,

I'm sorry to hear about the airlift; that must have been really scary for you...

I've been on both rituxan and cellcept and before rituxan my rheumy talked to me about the cases of rituxan-linked PML. Now the way he put it, I could either let lupus and aps kill me for sure, or take the truly miniscule risk of being the next patient to be one-in-a-million and get PML; he did say the choice was mine and it was a very obvious one for me! As far as the cellcept PML, that's one of my meds now too, the choice is still the same as far as I'm concerned; almost non-existent risk of PML (and it is almost non-existent if one thinks about how many people have taken cellcept worldwide over the ten years it's been on the market and how many of those have gotten PML!!) versus a very real risk of death from lupus and aps...At least that's the way I see it...

I remember my docs mentioning (and the internet articles mention this as well, both the ones on the rituxan pml cases and the cellcept ones) that the few patients that got PML were the ones that had recently been taking or were still taking multiple immunossupressants; and they talk about cytoxan and cyclosporine and rituxan or cellcept on top of those ones. The way my doc had explained it was that there is a limit to immunossupression within each person after which the JC virus may be activated (IF one has it!! Emphasis on that IF as that's not even a certainty!!) and the patient might get PML; and multiple immunossupressants might contribute to pushing one over that limit more than any one immunossupressant can.

The first time I got rituxan I was on monthly high dose cytoxan pulses, almost weekly steroid ones and had just gotten off cellcept too; so multiple immunossupressants there... I did not react positively to rituxan as the second infusion triggered an immune response so large that I had to stay in hospital for ten days just to get past it and that immune response in turn triggered my lupus and aps back into action; and it wasn't cellcept or rituxan, but the diseases themselves that have almost killed me since again and again... Rituxan did its job, in the sense that I don't have b-cells at all and I do feel that the combination of meds I've been on this past year (rituxan and cellcept included) helped a lot in keeping me here until today...! Of course that's just me... :hehe:

Are you taking cellcept throughout the lymphostat-b trials? What does your doc think about the cellcept related PML cases? Lymphostat-b is a very, very new med (as you know!!); but it has very promising results regardless!! :bigsmile: :thumbs: I really, truly hope it helps you loads and that you feel better very soon! Brain involvement is no fun indeed...! :grouphug2: :grhug:

:flowery:

Zoi

 

[tbunny1]

Is this a brand new study you are participating in for the b-mab? My rheumy tried to get me into a study for it back in 2003, but I was rejected due to my cns problems. I wonder if they have changed the criteria now?

Thanks for stepping up and volunteering for this! Without people like you, we wouldn't get anywhere in trying to find a better way to treat lupus than mass quantities of prednisone. Here's hoping that it goes well for you and the others!

 

[Sage Hen]

Hi Everyone,

At the complete risk of sounding ? What is PMD? I would very much like to know, since in am up to 2000 mgs. of CellCept..

Thanks,
Sandy

 

[Zoi]

Hi Sandy,

PML is short for progressive multifocal leuco-encephalopathy. It is a progressive neurological disorder caused by the activation of something called the JC virus in the brain. The JC virus is short for John Cunningham virus and people very commonly have it in dormant form after an initial infection (kind of like shingles if you will!), but reactivation of the JC virus that can occur in extremely rare cases of very immunossupressed patients can lead to PML which in turn incredibly rare.

Now the problem with PML besides the fact that only immunocompromised patients can get it (HIV patients, patients on immunossupressants etc) is that it progresses fast and is nearly always fatal. May I just add here Sandy, that the risk of being run over by a bus when one leaves the house is 1000 times higher than getting PML from something like cellcept or rituxan...! :hehe:

Hope you're doing ok,

Zoi

 

[Raglet]

hi Fran

sorry I missed your post. Rituxan never stopped some of my symptoms (balance continued to deteriorate), but it has helped other parts of my lupus.

I'm definitely no expert on this, but I don't think it would be a blood brain barrier issue as rituxan just works by depleting b cells which are involved in the manufacture of antibodies rather than targeting the brain. So improvement should be a by product of lowering antibodies.

But, my antibody levels never did drop - though parts of my lupus progression did slow down, particularly problems with my tongue, swallowing etc. All those problems have started deteriorating again. Rituxan never actually improved anything for me, my neuro damage is pretty much always permanent, it but I do think it slowed the progression rate.

feel better soon, and sorry i took so long to reply

raglet

 

[mumsy613]

Good to hear from you Raglet!

Well, the truth is out there for us.....somewhere :umm:

I am about to see a new neurologist. For some reason, my symptoms come and go in severity. Yet, I have no cns antibodies in the blood. Rituxan leveled all my antibodies to zero, but they return as b cells return...never any cns antibodies however.

Last week I was in hospital for bilateral pulmonary embolism with pleurisy and bilateral dvtt....one large clot in the right lung and shower of smaller in the left. I have never had any risk factors for clotting....all of a sudden lupus anticardiolipin antibodies show up. Strange and scarey. I have a nifty vena cava filter installed, so as protected from roaming clots as possible. This is what is holding up the new LP...coumadin therapy. Darn.

Other than very short pulses of prednisone (60-80mg), I have refused treatment short of Rituxan. The stacked up chemo drugs and immune suppressants were devastating for me. Other than CNS symptoms, Rituxan was a life saver. I am 18 months since the last infusion, so all antibodies are back up plus these new things. Symptoms getting worse again as well.
I am hoping this new neurology practice will have some new insight into the CNS issues.

Take care of yourself! Maybe this Blys thing will be helpful.....

Fran

 

[bamagirl79]

BLys/LymphoStat-B/Belimumab Trial

I have been in the trial since Nov.2007, were i am they said this was
Phase 4 of the study... Hope you are getting the real thing, as for me
My symptoms are some better, when i have a flare it is not as severe
as it was before the study, I think that maybe i am getting one of
the smaller doses in the study...
Where is your study at? I am at UAB Birmingham USA...
Pam